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2004;113;e597 Pediatrics

Slota and Beverly Corbo-Richert


F. Crean, Jean Johnson, Eileen Fairbanks, Leigh Small, Jeffrey Rubenstein, Margaret
Bernadette Mazurek Melnyk, Linda Alpert-Gillis, Nancy Fischbeck Feinstein, Hugh
Mothers
Mental Health/Coping Outcomes of Critically Ill Young Children and Their
Creating Opportunities for Parent Empowerment: Program Effects on the

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Creating Opportunities for Parent Empowerment: Program Effects
on the Mental Health/Coping Outcomes of Critically Ill
Young Children and Their Mothers
Bernadette Mazurek Melnyk, PhD, RN*; Linda Alpert-Gillis, PhD; Nancy Fischbeck Feinstein, PhD, RN*;
Hugh F. Crean, PhD*; Jean Johnson, PhD, RN*; Eileen Fairbanks, MS, RN*; Leigh Small, PhD, RN-CS*;
Jeffrey Rubenstein, MD; Margaret Slota, MN, RN; and Beverly Corbo-Richert, PhD, RN
ABSTRACT. Objective. Increasing numbers of chil-
dren in the United States (ie, 200 children per 100 000
population) require intensive care annually, because of
advances in pediatric therapeutic techniques and a
changing spectrum of pediatric disease. These children
are especially vulnerable to a multitude of short- and
long-term negative emotional, behavioral, and academic
outcomes, including a higher risk of posttraumatic stress
disorder (PTSD) and a greater need for psychiatric treat-
ment, compared with matched hospitalized children who
do not require intensive care. In addition, the parents of
these children are at risk for the development of PTSD,
as well as other negative emotional outcomes (eg, depres-
sion and anxiety disorders). There has been little research
conducted to systematically determine the effects of in-
terventions aimed at improving psychosocial outcomes
for critically ill children and their parents, despite recog-
nition of the adverse effects of critical care hospitaliza-
tion on the nonphysiologic well-being of patients and
their families. The purpose of this study was to evaluate
the effects of a preventive educational-behavioral inter-
vention program, the Creating Opportunities for Parent
Empowerment (COPE) program, initiated early in the
intensive care unit hospitalization on the mental health/
psychosocial outcomes of critically ill young children
and their mothers.
Design. A randomized, controlled trial with fol-
low-up assessments 1, 3, 6, and 12 months after hospital-
ization was conducted with 174 mothers and their 2- to
7-year-old children who were unexpectedly hospitalized
in the pediatric intensive care units (PICUs) of 2 chil-
drens hospitals. The final sample of 163 mothers ranged
in age from 18 to 52 years, with a mean of 31.2 years.
Among the mothers reporting race/ethnicity, the sample
included 116 white (71.2%), 33 African American (20.3%),
3 Hispanic (1.8%), and 2 Indian (1.2%) mothers. The mean
age of the hospitalized children was 50.3 months. Ninety-
nine children (60.7%) were male and 64 (39.3%) were
female. The major reasons for hospitalization were respi-
ratory problems, accidental trauma, neurologic problems,
and infections. Fifty-seven percent (n 93) of the chil-
dren had never been hospitalized overnight, and none
had experienced a previous PICU hospitalization.
Interventions. Mothers in the experimental (COPE)
group received a 3-phase educational-behavioral inter-
vention program 1) 6 to 16 hours after PICU admission, 2)
2 to 16 hours after transfer to the general pediatric unit,
and 3) 2 to 3 days after their children were discharged
from the hospital. Control mothers received a structurally
equivalent control program. The COPE intervention was
based on self-regulation theory, control theory, and the
emotional contagion hypothesis. The COPE program,
which was delivered with audiotapes and matching writ-
ten information, as well as a parent-child activity work-
book that facilitated implementing the audiotaped infor-
mation, focused on increasing 1) parents knowledge and
understanding of the range of behaviors and emotions
that young children typically display during and after
hospitalization and 2) direct parent participation in their
childrens emotional and physical care. The COPE work-
book, which was provided to parents and children after
transfer from the PICU to the general pediatric unit,
contained 3 activities to be completed before discharge
from the hospital, ie, 1) puppet play to encourage expres-
sion of emotions in a nonthreatening manner, 2) thera-
peutic medical play to assist children in obtaining some
sense of mastery and control over the hospital experi-
ence, and 3) reading and discussing Jennys Wish, a story
about a young child who successfully copes with a stress-
ful hospitalization.
Outcome Measures. Primary outcomes included ma-
ternal anxiety, negative mood state, depression, maternal
beliefs, parental stress, and parent participation in their
childrens care, as well as child adjustment, which was
assessed with the Behavioral Assessment System for
Children (parent form).
Results. COPE mothers reported significantly less pa-
rental stress and participated more in their childrens
physical and emotional care on the pediatric unit, com-
pared with control mothers, as rated by nurses who were
blinded with respect to study group. In comparison with
control mothers, COPE mothers reported less negative
mood state, less depression, and fewer PTSD symptoms
at certain follow-up assessments after hospitalization. In
addition, COPE mothers reported stronger beliefs re-
garding their childrens likely responses to hospitaliza-
tion and how they could enhance their childrens adjust-
ment, compared with control mothers. COPE children, in
comparison with control children, exhibited significantly
fewer withdrawal symptoms 6 months after discharge, as
well as fewer negative behavioral symptoms and exter-
nalizing behaviors at 12 months. COPE mothers also
reported less hyperactivity and greater adaptability
among their children at 12 months, compared with con-
trol mothers. One year after discharge, a significantly
higher percentage of control group children (25.9%) ex-
From the *School of Nursing and School of Medicine and Dentistry,
University of Rochester, Rochester, New York; and Department of Nurs-
ing, Childrens Hospital of Pittsburgh, Pittsburgh, Pennsylvania.
Received for publication Feb 2, 2004; accepted Feb 2, 2004.
Reprint requests to (B.M.M.) University of Rochester School of Nursing, 601
Elmwood Ave, Box SON, Rochester, NY 14642. E-mail: bernadette
melnyk@urmc.rochester.edu
PEDIATRICS (ISSN 0031 4005). Copyright 2004 by the American Acad-
emy of Pediatrics.
http://www.pediatrics.org/cgi/content/full/113/6/e597 PEDIATRICS Vol. 113 No. 6 June 2004 e597
by guest on May 31, 2014 pediatrics.aappublications.org Downloaded from
hibited clinically significant behavioral symptoms, com-
pared with COPE children (2.3%). In addition, 6 and 12
months after discharge, significantly higher percentages
of control group children exhibited clinically significant
externalizing symptoms (6 months, 14.3%; 12 months,
22.2%), compared with COPE children (6 months, 1.8%;
12 months, 4.5%).
Conclusions. The findings of this study indicated that
mothers who received the COPE program experienced
improved maternal functional and emotional coping out-
comes, which resulted in significantly fewer child adjust-
ment problems, in comparison with the control group.
With the increasing prevalence of attention-deficit/hy-
peractivity disorder and externalizing problems among
children and the documented lack of mental health
screening and early intervention services for children in
this country, the COPE intervention could help protect
this high-risk population of children from developing
these troublesome problems. As a result, the mental
health status of children after critical care hospitalization
could be improved. With routine provision of the COPE
program in PICUs throughout the country, family bur-
dens and costs associated with the mental health treat-
ment of these problems might be substantially reduced.
Pediatrics 2004;113:e597e607. URL: http://www.
pediatrics.org/cgi/content/full/113/6/e597; pediatric inten-
sive care unit, coping, outcomes, parents, young children.
ABBREVIATIONS. PICU, pediatric intensive care unit; BASC, Be-
havioral Assessment System for Children; ICU, intensive care
unit; PTSD, posttraumatic stress disorder; COPE, Creating Oppor-
tunities for Parent Empowerment.
I
ncreasing numbers of children in the United
States (ie, 200 children per 100 000 population)
require intensive care annually, because of ad-
vances in pediatric therapeutic methods and a
changing spectrum of pediatric disease.
1
It has been
projected that there will be continued growth in the
number of pediatric intensive care unit (PICU) beds
well into the new millennium, with a higher level of
illness acuity for children occupying them.
2
Critically ill children hospitalized in intensive care
units (ICUs) are especially vulnerable to a multitude
of short- and long-term, negative emotional, behav-
ioral, and academic outcomes, including a higher
risk of posttraumatic stress disorder (PTSD) and a
greater need for psychiatric treatment, compared
with matched hospitalized children who do not re-
quire intensive care.
3
In addition, the parents of these
children are at risk for the development of PTSD, as
well as other negative emotional outcomes (eg, de-
pression and anxiety disorders).
46
Little research has been conducted to determine
systematically the effects of interventions aimed at
improving psychosocial outcomes for critically ill
children and their parents, despite recognition of the
adverse effects of critical care hospitalization on the
nonphysiologic well-being of these patients and their
families. Although numerous studies have demon-
strated the positive effects of including parents in the
psychologic preparation of children for planned mi-
nor operations and procedures,
79
it is empirically
unknown whether similar approaches initiated early
in the ICU hospitalization would benefit critically ill
children and their parents. Therefore, the urgent
need to test interventions aimed at improving the
mental health and coping outcomes for this high-risk
population is immediately evident.
Our pilot study demonstrated the positive effects
of an educational-behavioral intervention program
titled Creating Opportunities for Parent Empower-
ment (COPE) on short-term coping outcomes for 30
mothers and their 1- to 6-year-old, critically ill chil-
dren, up to 1 month after hospitalization.
6
Because
short-term findings from our pilot project were
promising, this study was undertaken with the pri-
mary aims of determining whether the outcomes
could be replicated within the context of a full-scale,
randomized, controlled trial and evaluating whether
the COPE program could have sustained positive
effects on the process and outcomes of maternal and
child coping with critical illness for up to 1 year after
hospital discharge.
Design of the COPE intervention was driven by
self-regulation theory,
10,11
control theory,
12,13
and the
emotional contagion hypothesis.
1416
On the basis of
self-regulation and control theories, we hypothe-
sized that the COPE intervention would strengthen
mothers beliefs and knowledge of the typical behav-
iors and emotions to expect from their young chil-
dren as they recovered from a critical illness and
would remove barriers to enhance their ability to
facilitate their childrens adjustment. COPE mothers
were expected to experience less negative mood and
to support their children more effectively during and
after hospitalization, compared with mothers who
received the control program. On the basis of the
emotional contagion hypothesis, we thought that ef-
fective parental coping among the COPE mothers
would lead to better adjustment outcomes for their
children.
METHODS
Study Design
A randomized controlled trial was designed in which subjects
at each of 2 study sites were randomly assigned, after providing
informed consent, to receive either the COPE program or a control
program, in 1-week blocks of time to decrease the probability of
staff-to-parent and parent-to-parent contamination (ie, the likeli-
hood that parents in the PICU who were in different study groups
would exchange content that was provided to them in their ex-
perimental program). Both groups received an educational-behav-
ioral intervention program (ie, COPE or control), which was de-
livered in 3 phases, as follows: phase I, within 6 to 16 hours after
the child was admitted to the PICU; phase II, within 2 to 16 hours
after the child was transferred from the PICU to the general
pediatric unit; phase III, within 2 to 3 days after the child was
discharged from the hospital. Follow-up assessments were com-
pleted 1, 3, 6, and 12 months after discharge. Procedures were
followed in accordance with the ethical standards of the institu-
tional research subject review boards and the Helsinki Declaration
of 1975, as revised in 1983. Enrollment and follow-up monitoring
of participants occurred from January 1998 through March 2002.
Participants
All mothers who could read and speak English with children
admitted to either of the 2 PICU study sites (ie, a 12-bed PICU at
a 124-bed childrens hospital within a 720-bed academic medical
center in upstate New York or a 31-bed PICU at a 235-bed chil-
drens hospital in southwestern Pennsylvania) were eligible to
participate if their children 1) had an unplanned medical or sur-
gical admission to the PICU, 2) were between 2 and 7 years of age,
3) were expected to survive, 4) had no prior ICU admissions, 5)
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had no cancer, and 6) had no suspected or diagnosed physical or
sexual abuse. Mothers were excluded from data analysis if 1) their
children were readmitted to the PICU after transfer from the PICU
to the general pediatric unit, 2) their children were hospitalized in
the PICU for 21 days, or 3) they made a personal decision to
withdraw from the study. We chose to focus solely on mothers to
eliminate the possibility of substantial variability in the data,
because evidence has indicated that there are marked differences
in the responses of fathers and mothers to childhood critical
illness.
17
Of 212 eligible mothers, 38 (18%) refused, with the ma-
jority stating that they were too stressed or too tired to participate
(n 17) or that they wanted to focus only on their children (n
7).
The convenience sample was composed of 174 mothers (90 in
the COPE group and 84 in the control group). After enrollment
and randomization to a study group, data for 3 COPE mothers
were eliminated, because of a prior admission to the PICU (n 1),
readmission to the PICU before discharge (n 1), or death after
multiple readmissions to the PICU (n 1). Data for 8 control
mothers were eliminated from analyses because of an extended
PICU stay of 21 days (30 days) (n 1), readmission to the PICU
before hospital discharge (n 5), a planned admission (n 1), or
death (n 1). Therefore, the final sample for data analyses in-
cluded 163 mothers and their children.
Mothers in the final sample ranged in age from 18 to 52 years,
with a mean of 31.2 years (SD: 6.3 years). They had a mean number
of 1.7 other children at home (SD: 1.4 children; range: 06 chil-
dren). The sample included 116 white mothers (71.2%), 33 African
American mothers (20.3%), 3 Hispanic mothers (1.8%), and 2
Indian mothers (1.2%). Two mothers (1.2%) reported that they
were of other races, and 7 (4.3%) did not report their ethnic
groups. One hundred thirty-three mothers (81.6%) had completed
high school. Seventy-eight (47.8%) were in their first marriages, 36
(22.1%) had never married, 5 (3.1%) were separated from their
husbands, 12 (7.4%) were divorced, 21 (12.9%) were in their sec-
ond marriages, and 11 (6.7%) did not report their marital status.
The household income for the majority of families (n 102, 62.6%)
was at least $15 000/year (see Table 1 for baseline characteristics of
the mothers in both study groups).
The mean age of the hospitalized children was 50.3 months (SD:
18.9 months; range: 2288 months). Ninety-nine children were
male (60.7%) and 64 (39.3%) were female. The major reasons for
hospitalization were respiratory problems (eg, asthma or pneu-
monia) (n 71, 43.6%), accidental trauma (n 26, 16%), neuro-
logic problems (eg, seizures or accidents) (n 22, 13.5%), infec-
tions (eg, meningitis or sepsis) (n 18, 11%), hematologic
problems (eg, bleeding after procedures) (n 8, 4.9%), cardiac
problems (n 3, 1.9%), ingestions (n 7, 4.3%), or other causes
(eg, acidosis) (n 8, 4.9%). Fifty-seven percent (n 93) of the
children had never been hospitalized overnight. Pediatric Risk of
Mortality scores
18
averaged 4.4 (SD: 4.9; range: 031) on a scale of
0 to 76, with 0 representing no risk of death. The length of stay in
the PICU averaged 64.3 hours (SD: 64.3 hours; range: 10.0440.0
hours), and the total length of hospital stay averaged 6.9 days (SD:
6.3 days; range: 132 days) (see Table 2 for baseline characteristics
of children in both study groups).
The COPE Program
The experimental program focused on increasing 1) parents
knowledge and understanding of the range of behaviors and
emotions that young children typically display during and after
hospitalization and 2) direct parent participation in their chil-
drens emotional and physical care. Phase I of the intervention in
the PICU consisted of audiotaped information and matching writ-
ten information.
Phase II of the COPE intervention, a booster intervention that
occurred shortly after transfer from the PICU to the general pedi-
atric unit, consisted of 1) audiotaped and written information that
reinforced critical content of the initial audiotape and provided
additional information on childrens responses during and after
hospitalization, as well as providing mothers with additional sug-
gestions to enhance coping outcomes for their children, and 2) a
parent-child activity workbook. The workbook contained 3 activ-
ities to be completed before discharge from the hospital, ie, 1)
puppet play to encourage expression of emotions in a nonthreat-
ening manner, 2) therapeutic medical play to assist children in
obtaining some sense of mastery and control over the hospital
experience, and 3) reading and discussing Jennys Wish, a story
about a young child who successfully copes with a stressful hos-
pitalization.
Phase III of the COPE intervention program, the second booster
intervention, occurred 2 to 3 days after hospital discharge and
consisted of a telephone call, during which a 5-minute script that
reinforced the following was read: 1) young childrens typical
postdischarge emotions and behaviors and 2) parenting behaviors
that would continue to facilitate positive coping outcomes for the
children. Mothers were encouraged to continue to perform the
activities from the workbook they had received during hospital-
ization. Immediately after the telephone intervention, the tele-
phone script was mailed to the mothers.
TABLE 1. Baseline Characteristics of Mothers Enrolled in the
COPE Randomized Trial (Participants [N 163] by Random
Assignment)
Characteristics COPE
(n 87)
Control
(n 76)
P
Value
Mothers
Mean age, years (SD) 32.0 (5.8) 30.1 (6.8) .12
Race/ethnicity, n (%)
White 65 (74.7) 51 (67.1) .28
Black 15 (17.3) 18 (23.7)
Hispanic 1 (1.1) 2 (2.6)
Indian 2 (2.3) 0 (0)
Other 2 (2.3) 0 (0)
Not reported 2 (2.3) 5 (6.6)
Income, yearly, n (%)
$15 000 27 (31.0) 17 (22.4) .12
$15 001$30 000 14 (16.1) 24 (31.6)
$30 000 37 (42.5) 27 (35.5)
Not reported 9 (10.4) 8 (10.5)
Marital status, n (%)
Married 45 (51.7) 33 (43.3) .82
Separated 2 (2.3) 3 (3.9)
Divorced 6 (6.9) 6 (7.9)
Never married 17 (19.5) 19 (25.0)
Second marriage 11 (12.6) 10 (13.2)
Education level completed,
n (%)
Less than high school 11 (12.7) 8 (10.5) .06
High school 18 (20.7) 33 (43.4)
14 years of college 45 (51.7) 26 (34.2)
Graduate school 7 (8.0) 4 (5.3)
Not reported 6 (6.9) 5 (6.6)
TABLE 2. Baseline Characteristics of Children Enrolled in the
COPE Randomized Trial (Participants [N 163] by Random
Assignment)
Characteristics COPE
(n 87)
Control
(n 76)
P
Value
Children
Mean age in months (SD) 50.7 (19.3) 49.5 (18.6) .70
Gender, n (%)
Male 53 (60.9) 46 (60.5) .96
Female 34 (39.1) 30 (39.5)
Prism, mean (SD) 4.2 (4.9) 4.7 (4.8) .51
Type of admission, n (%)
Medical 75 (86.2) 58 (76.3) .10
Surgical 12 (13.8) 18 (23.7)
Prior hospitalization, n (%)
No 45 (51.7) 36 (47.4) .40
Yes 35 (40.2) 35 (46.0)
Not reported 7 (8.1) 5 (6.6)
Length of stay, mean,
days (SD)
PICU 2.8 (2.7) 2.8 (2.6) .86
Pediatrics unit 4.4 (5.9) 3.7 (3.4) .37
Total 6.8 (6.8) 6.9 (5.7) .92
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The Control Program
The structurally equivalent control program also consisted of 3
phases, which occurred at the same times as the COPE program
phases. Phase I provided audiotaped and written information on
the services and policies of the PICU. Phase II consisted of 1)
audiotaped and written information about the general pediatric
unit and its policies and 2) a parent-child activity workbook
containing control activities (eg, reading a non-hospital-related
book and working with modeling compound). Phase III of the
control program consisted of a telephone call made 2 to 3 days
after discharge, during which mothers were informed that they
should contact their primary health care providers if their children
were having any problems or unusual symptoms. During the
telephone call, the mothers were asked to comment on their chil-
drens hospital stays.
Measures
Instruments with established construct validity and reliability
were used to measure the primary outcomes of the study. These
instruments, with their Cronbach values for this sample, are
summarized in Table 3. Higher scores on the State Anxiety Inven-
tory,
19
the Profile of Mood States,
20
and the Parental Stressor Scale:
PICU
21
are indicative of greater state anxiety, negative mood state,
and parental stress.
The Post-Hospital Stress Index for Parents and the Post-Hospi-
tal Stress Index for Children were based on criteria for the diag-
nosis of PTSD, as published in the Diagnostic and Statistical Manual
of Mental Disorders (4th ed).
4
Parents completed these two 20-item
questionnaires regarding their own symptoms and their childrens
symptoms by checking either the yes or no column in re-
sponse to each of the questions (eg, Do you experience frequent
distressing memories of the hospitalization?). Content validity
was established by 3 psychiatrists and 3 psychologists. Scoring
consisted of totaling the number of positive responses; therefore,
total scores could range from 0 to 20. Subjects reporting 7 PTSD
symptoms were referred to their primary care physicians for
follow-up care.
The mothers involvement in their childrens care was assessed
with the Index of Parent Participation,
22
a 36-item instrument
describing parenting behaviors in which mothers could engage
during their childrens hospitalizations (eg, bathing the child or
explaining a test or procedure). Scores were computed by sum-
ming the parenting behaviors, with a higher score indicating more
parent participation. The nurses completed this measure while the
children were in the PICU, and the mothers completed it while
their children were in the general pediatric unit. In addition, the
childrens primary nurses, who were blinded with respect to the
study groups, were asked to make hatch marks on 2 visual analog
scales (10 cm), indicating the extent to which the childrens moth-
ers participated in the physical and emotional care of their chil-
dren in the PICU and in the general pediatric unit. Higher scores
on each of these scales indicated greater involvement by mothers
in their childrens care.
Childrens adjustment was measured by using the Behavioral
Assessment System for Children (BASC) (parent form).
23
The
BASC is a comprehensive measure of both adaptive and problem
behaviors. Mothers rated their children, during the past 6 months,
for each of the 131 items on a 4-point scale, ranging from 1 (never)
to 4 (always). Composite subscales included externalizing prob-
lems, internalizing problems, behavioral symptoms, and adaptive
skills.
The Parental Belief Scale for Parents of Hospitalized Children
24
was used to measure parental beliefs about their hospitalized
childrens responses and their role during hospitalization. Twenty
items assessed parental beliefs about the hospitalized childs re-
sponses (eg, I know what changes in behavior to expect in my
hospitalized child) and the parental role during hospitalization
(eg, I am clear about the things that I can do to best help my
child). Parents indicated agreement with each item on a 5-point
scale, ranging from 1 (strongly disagree) to 5 (strongly agree). Item
scores were summed, with a possible range of scores of 20 to 100;
higher scores indicated stronger beliefs.
Manipulation Checks
To assess whether subjects processed the information they re-
ceived at the 3 intervention points, mothers answered 12 manip-
ulation check questions (6 of the 12 questions were specific to the
COPE program and 6 were specific to the control program).
Higher scores for the mothers on the questions relevant to their
experimental program provided evidence of processing of the
information for the study condition. The timing of the interven-
TABLE 3. Variable, Measures, and Measurement Schedule
Variables Measures Cronbachs Time*
1 2 3 4 5 6 7 8 9
Maternal emotional outcomes
State anxiety State Anxiety Inventory (A-State)
19
.94.96
Negative mood state Profile of Mood States (POMS, Short-form)
20
.92.96
Depression Depression Subscale, Profile of Mood States
(POMS)
20
.92.96
Stress related to PICU and
pediatric unit
Parental Stressor Scale: PICU (PSS:PICU)
21
.90.91
Posthospitalization stress Post Hospitalization Stress Index for Parent
(PSI-P)
24
.83.85
Maternal functional outcomes
Involvement in physical
care
Involvement in Physical Care (VAS-PC) NA
Involvement in emotional
care
Involvement in Emotional Care (VAS-EC) NA
Parent participation in care Index of Parent Participation (IPP)
22
.85
Other key maternal variables
Parental beliefs Parental Beliefs Scale (PBS)
24
.91
Manipulation checks Manipulation checks NA
Evaluation Self-report questionnaire NA
Child adjustment outcomes
Posthospital stress Posthospital Stress Index for Children
(PSI-C)
24
.78.85
Child behavior Behavioral Assessment Scale for Children
(BASC)
23
.92.95
* Time 1 indicates phase I intervention (616 hours after PICU admission); time 2, observation contact (1630 hours after PICU admission);
time 3, phase II intervention (216 hours after transfer to pediatric unit); time 4, observation contact (2436 hours after transfer to pediatric
unit); time 5, phase III intervention (23 days after hospital discharge); time 6, 1 month postdischarge follow-up (1 month after hospital
discharge); time 7, 3 months postdischarge follow-up (3 months following hospital discharge); time 8, 6 months postdischarge follow-up
(6 months following hospital discharge); time 9, 12 months postdischarge follow-up (12 months following hospital discharge).
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tions and the collection of outcome measures is summarized in
Table 3.
RESULTS
Data Analyses
To confirm that randomization produced equiva-
lent study groups within and across study sites, fre-
quency distributions and descriptive statistics (ie,
means, medians, modes, and SDs) were calculated
for all demographic and clinical variables, as well as
preintervention measures. No distribution anomalies
were found. Students t tests,
2
tests, and analyses of
variance were conducted to examine the data for
baseline group or site differences. Subjects from the 2
study sites were similar with respect to most vari-
ables, except 1) the gender of the child, 2) the type of
admission (surgical or medical), 3) the use of re-
straints, and 4) the fathers level of education. To
help control for these site differences, a decision was
made to enter site as a covariate in subsequent anal-
yses. Because maternal trait anxiety was highly cor-
related with a multitude of the studys dependent
variables (eg, mothers depression and child out-
comes), it also was used as a covariate in subsequent
data analyses. To help control for preintervention
group differences, maternal education and income
were used as covariates, because they were corre-
lated significantly with each other and because edu-
cation was correlated with experimental condition.
Analyses of covariance were used to test the study
hypotheses. A repeated-measures approach was not
used, because such an approach demands listwise
deletion of data, which would severely limit the use
of available data for this sample.
Despite multiple attempts to gather all posthospi-
talization mailed survey questionnaires from the
subjects, there was a 58.2% rate of attrition in the
study by 1 year after hospitalization (n 44, 50.5%,
in the COPE group and n 51, 67%, in the control
group). Because of the smaller numbers of subjects at
postdischarge time points, which resulted in low
observed power of our statistical tests to detect sig-
nificant findings, a decision was made to calculate
and report effect sizes for the studys outcome vari-
ables, as well as the traditional results from statistical
analyses. Effect sizes are not dependent on sample
size and help avoid type II errors in the interpreta-
tion of the findings. Pooled within-group SDs were
used to calculate effect sizes, and values of .2, .5, and
.8 were used to define small, medium, and large
effects, respectively.
25
Table 4 presents the study
findings.
Maternal Emotional Outcomes During Hospitalization
There were no differences with respect to state
anxiety and total negative mood state during hospi-
talization. The 2 groups demonstrated similar pat-
terns of decline across the 4 time points at which
these variables were measured (Table 4).
Although there was only a small positive effect of
the COPE program on maternal reports of overall
parental stress during the PICU stay, as assessed
with the Parental Stressor Scale: PICU (Table 4),
mothers in the COPE group reported significantly
less stress regarding staff communication than did
control group mothers (COPE: mean score 4.3, SD
3.9; control: mean score 6.0, SD 5.9; P .05).
Mothers in the COPE group reported significantly
less total stress on the Parental Stressor Scale: PICU
after transfer to the general pediatric unit, compared
with control mothers (Table 4). Specifically, COPE
mothers reported significantly less stress, compared
with control mothers, on the following subscales: 1)
their childrens appearance (COPE: mean 2.9, SD
2.9; control: mean 4.7, SD 4.0; P .01), 2) their
childrens procedures (COPE: mean 10.8, SD6.9;
control: mean 13.6, SD 7.7; P .05), and 3) their
childrens behaviors and emotions (COPE: mean
19.0, SD 9.8; control: mean 23.4, SD 11.9; P
.01).
Mothers Involvement in Their Childrens Care
Nurses who were blinded with respect to study
groups rated the COPE mothers as significantly more
involved in their childrens physical care on the pe-
diatric unit, compared with control mothers (Table
4). In addition, they rated COPE mothers as being
more involved in their childrens emotional care on
the pediatric unit, compared with control mothers.
There were no significant differences related to ma-
ternal involvement in care rated by the PICU nurses.
Maternal Anxiety and Negative Mood After
Hospitalization
Although there were no significant differences be-
tween groups, positive effect sizes (range: .25.40)
were found for the COPE program with respect to
maternal state anxiety at 3 of the 4 postdischarge
time points. With respect to total negative mood
state, COPE mothers reported significantly less neg-
ative mood 1 month after hospitalization, compared
with control mothers (Table 4). In addition, there was
a trend for COPE mothers to report less total nega-
tive mood 1 year after hospitalization, compared
with control mothers (P .10, medium effect size).
There were also small positive effects of the COPE
program on total negative mood state at all of the
postdischarge time points (range: .29.42). Specifi-
cally, COPE mothers reported significantly less de-
pression 1 month after hospitalization and 6 months
after hospitalization, compared with control mothers
(Fig 1), with effect sizes ranging from .20 to .45.
PTSD Symptoms
Because the number of stressful events in the year
before hospitalization was correlated significantly
with PTSD symptoms after hospitalization (r .24
.25, P .05, across the 4 postdischarge time points),
this variable was used as a covariate in this analysis,
in addition to site and trait anxiety. There were dif-
ferences in mothers work status after hospitaliza-
tion, and this variable was also controlled for in the
analysis.
There were no significant differences in reports of
PTSD symptoms in the COPE and control groups 1
and 3 months after hospitalization, although there
was a small positive effect (effect size: .22) for the
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COPE program at 3 months. There was a trend for
the COPE mothers to report fewer PTSD symptoms
at 6 months, compared with the control mothers,
even after controlling for the number of stressful
events before hospitalization. At 12 months, the
COPE mothers reported statistically fewer PTSD
symptoms, compared with the control mothers (Fig
2).
Child Adjustment
COPE mothers reported significantly fewer behav-
ioral symptoms for their children on the BASC be-
havioral symptoms index composite 12 months after
discharge, compared with control mothers (Fig 3).
One year after discharge, there was a significantly
higher percentage of control group children (25.9%)
with clinically significant behavioral symptoms,
compared with COPE group children (2.3%) (
2
[1
df] 9.36, P .01). In addition, although it was not
significant, there was a small positive effect (effect
size: .27) for the COPE program with respect to the
behavioral symptoms index composite 3 months af-
ter discharge.
With respect to the other BASC composite sub-
scales, COPE mothers reported significantly fewer
externalizing problems for their children 12 months
TABLE 4. Maternal Outcomes
Outcome Cope Group Comparison
Group
F Effect
Size*
N Mean (SD) N Mean (SD)
Maternal emotional variables
State anxiety
Time 1 78 52.8 (13.0) 68 52.8 (12.6) .001 .002
Time 2 72 45.6 (13.4) 51 45.0 (11.8) .07 .04
Time 3 77 42.4 (12.8) 70 42.4 (12.9) .001 .00
Time 4 75 40.6 (12.6) 63 41.0 (13.6) .33 .03
Time 6 59 35.7 (12.2) 44 39.8 (14.3) 3.21 .32
Time 7 50 38.4 (13.9) 43 40.7 (12.3) .90 .17
Time 8 55 36.0 (11.1) 34 39.1 (13.8) 1.75 .25
Time 9 42 35.8 (12.8) 25 40.9 (12.5) 3.21 .40
Negative mood state
Time 1 76 53.2 (21.5) 67 51.1 (19.7) .47 .10
Time 2 72 45.6 (21.2) 51 41.7 (19.6) 1.37 .19
Time 3 77 43.2 (19.8) 68 43.6 (21.4) .02 .01
Time 4 75 38.2 (21.8) 59 39.4 (21.9) .13 .05
Time 6 58 31.0 (19.1) 43 38.7 (23.5) 4.09 .36
Time 7 50 33.7 (22.7) 42 40.2 (23.7) 2.24 .32
Time 8 55 26.9 (17.8) 35 33.1 (26.0) 2.46 .29
Time 9 42 27.9 (21.2) 24 36.9 (21.2) 3.46 .42
Depression
Time 1 76 6.0 (4.3) 67 5.7 (4.1) .26 .07
Time 2 72 4.5 (4.5) 51 3.8 (4.0) .90 .16
Time 3 77 3.7 (4.4) 68 3.8 (4.2) .02 .02
Time 4 75 3.3 (4.2) 60 3.2 (4.4) .001 .02
Time 6 59 2.6 (3.3) 46 4.1 (4.3) 4.26 .39
Time 7 52 3.3 (4.4) 45 4.2 (4.6) 1.11 .20
Time 8 58 2.0 (3.3) 41 3.9 (5.2) 6.30 .45
Time 9 42 2.5 (4.0) 24 3.6 (4.0) 1.73 .27
Parent stress during hospitalization
Time 2 70 67.7 (23.8) 52 76.0 (33.3) 2.94 .29
Time 3 77 57.3 (28.3) 68 70.0 (34.6) 6.38 .40
Parent posthospitalization stress
Time 6 61 7.3 (4.2) 44 7.1 (4.3) .003 .01
Time 7 52 6.4 (4.3) 43 7.4 (4.9) 1.36 .23
Time 8 57 5.6 (4.0) 36 7.4 (5.7) 2.09 .31
Time 9 44 5.8 (3.8) 25 7.8 (5.0) 3.86 .49
Maternal functional outcomes
Involvement in physical care of child
Time 2 70 70.7 (19.6) 50 64.9 (23.8) 2.15 .20
Time 4 70 75.6 (20.3) 57 65.6 (25.4) 6.22 .43
Involvement in emotional care of child
Time 2 70 74.9 (19.4) 48 72.7 (19.8) .36 .17
Time 4 70 78.8 (16.5) 56 68.3 (23.8) 8.70 .51
Parent participation in care
Time 2 74 .35 (.18) 57 .38 (.22) .35 .15
Time 4 78 26.5 (5.6) 63 24.9 (7.0) 2.06 .25
Parental beliefs
Time 4 75 72.7 (10.0) 61 69.0 (13.5) 3.80 .31
* Small effect size .20; medium effect size .50; large effect size .80.
Baseline scores prior to interventions.
P .05.
P .01.
P .05 with multiple imputation analysis.
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after discharge, compared with control mothers (Fig
4; Table 5). At 6 and 12 months after discharge, there
was a significantly higher percentage of control
group children with clinically significant externaliz-
ing symptoms (6 months, 14.3%; 12 months, 22.2%),
compared with the COPE children (6 months, 1.8%;
12 months, 4.5%) (
2
[1 df] at 6 months 5.59, P
.05;
2
[1 df] at 12 months 5.23, P .05). Although
there was no statistically significant difference be-
tween the 2 study groups with respect to the adap-
tive skills composite and the internalizing composite,
there were positive effects of the COPE program at
12 months (effect size: .45 and .38, respectively).
With respect to specific BASC subscales, COPE
mothers reported significantly fewer withdrawal
symptoms at the 6-month follow-up assessment
(COPE: mean 42.5, SD 28.5; control: mean
30.4, SD 23.1; P .05, effect size: .45). In addition,
although values were not significantly different,
there was a small positive effect (effect size: .42) of
the COPE program on attention problems 6 months
after hospitalization.
Twelve months after discharge, COPE mothers
rated their children significantly lower on the hyper-
activity BASC subscale and higher on the adaptabil-
ity BASC subscale, in comparison with control moth-
ers. There was also a trend for the COPE children to
be rated as less depressed (P .10, effect size: .49).
Although they were not statistically significant, there
were small positive effects of the COPE program on
aggression (effect size: .41), anxiety (effect size: .29),
and attention problems (effect size: .20). In addition,
22.2% of the control group children met the criteria
for clinically significant maladaptive behaviors,
compared with 6.8% of the COPE group children (
2
[1 df] 3.59, P .10).
Maternal Beliefs
COPE mothers reported statistically stronger be-
liefs regarding their childrens likely responses to
hospitalization and how they could enhance their
childrens adjustment, compared with control moth-
ers (COPE: mean 72.7, SD 10; control: mean
69.0, SD 13.5; P .05).
Attrition Analyses
The data were analyzed to determine whether
families who left the study were different with re-
Fig 1. Maternal depression with time.
*P .05.
Fig 2. Maternal PTSD symptoms. *P .05.
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spect to major demographic factors (eg, age, race, or
gender) and/or baseline clinical variables (eg, Pedi-
atric Risk of Mortality scores or mothers trait anxi-
ety), as well as the BASC measures before the 12-
month follow-up assessment. Analyses indicated
that there were no significant differences in any of
these measures between families who remained in
the study at the 12-month follow-up assessment and
those who left the study. Because of the attrition rate
from 6 months to 12 months, a systematic analysis
was conducted to assess whether the study findings
were influenced by patterns of missing data. There
were no predictors of missing data except for group
assignment (the control group had more missing
data with time) and race (the percentage of nonwhite
respondents decreased with time). However, the ef-
fects of the treatment did not differ according to race,
and race did not predict outcomes at any time point.
To examine the robustness of the study findings
more thoroughly, multiple-imputation strategies
were used. In general, multiple imputation imputes
missing scale values with regression-based maximal
likelihood procedures but also incorporates random
error into the estimates.
26
To improve estimates, key
demographic factors and the important covariates
were used in the imputation strategy, and the pro-
cedures described by Allison
27
for intervention stud-
ies were used. Ten imputations were performed, and
each of the 10 datasets was analyzed as described
above. The results obtained for each of the 10 data-
sets were combined by using the techniques de-
scribed by Rubin.
28
Overall, the results obtained with multiple impu-
tation confirmed the findings derived by using list-
wise techniques. Specifically, COPE mothers 1) were
significantly more involved in their childrens phys-
ical and emotional care in the pediatric unit, 2) were
less stressed regarding their childrens overall ap-
pearance, 3) reported less total negative mood 1 year
after hospitalization, 4) reported fewer externalizing
problems for their children 12 months after dis-
charge, and 5) reported fewer aggressive problems
for their children 1 year after discharge (all P .05).
Moreover, there were trends for differences between
the 2 groups, with COPE mothers reporting 1) less
total stress after transfer to the general pediatric unit,
2) less stress regarding their childrens medical pro-
cedures and their childrens behaviors and emotions,
3) less negative mood and depression 1 month after
hospitalization, 4) fewer PTSD symptoms 6 months
after hospitalization, and 5) less depression among
their children 12 months after discharge, compared
with control mothers. The level of agreement in the
findings between the listwise and multiple-imputa-
Fig 3. BASC behavioral symptoms index
for the children. *P .05.
Fig 4. BASC externalizing behaviors among the
children. *P .05.
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tion approaches to the handling of missing data in-
creases the robustness of the findings.
DISCUSSION
The principal finding of this study is that the men-
tal health/psychosocial outcomes of critically ill chil-
dren can be improved by enhancing their mothers
coping outcomes, during and after hospitalization,
with the COPE program. Despite low statistical
power at the 12-month follow-up assessments, there
were significant differences between the COPE and
control groups with respect to major maternal and
child outcome variables, with positive effects of the
COPE intervention. Therefore, we think that the
findings of this study represent true improvements
among critically ill children and their mothers who
received the experimental program, with the results
of this study supporting the value of the COPE in-
tervention in improving the mental health and cop-
ing outcomes of mothers and young children who
experience critical care hospitalization.
Because the COPE program created a clear cogni-
tive schema for their childrens likely behaviors and
emotions as they recovered from critical illnesses,
mothers reported stronger beliefs regarding their
ability to understand and predict their childrens
responses to hospitalization. As a result, COPE
mothers experienced less parental stress after their
children were transferred to the general pediatric
unit, in comparison with control mothers. The
mounting evidence regarding the findings from this
study and our previous work
6,22,29,30
provides strong
support for the self-regulation theory
10
in explaining
how the child behavior component of the COPE
program positively affects maternal coping.
A lack of differences between the COPE and con-
trol group mothers with respect to state anxiety and
negative mood state during hospitalization may be
attributable to the fact that the length of hospital stay
for this full-scale clinical trial was approximately
one-half of that in our pilot study.
6
There might not
have been enough time to demonstrate the positive
effects of the COPE program on maternal anxiety
and mood state during the short course of hospital-
ization in this trial. The control group did receive an
intervention at a high-stress time, which might have
decreased anxiety and negative mood, in comparison
with a pure control group receiving standard care
only.
COPE mothers did report less anxiety and nega-
tive mood state (specifically depression) at various
times after hospitalization. In addition to statistically
significant differences, there were clinically mean-
ingful differences in state anxiety; mothers in the
control group scored in the 72nd to 73rd percentile of
standardized normative values, compared with
mothers in the COPE group, who scored in the 58th
to 59th percentile 12 months after discharge. Overall,
upon reflection, the hospitalization might have been
less stressful for the COPE parents than the control
parents. Because mothers in the COPE group were
reported as being more involved in their childrens
emotional and physical care in the pediatric unit,
they might have felt better about their ability to cope
with the stressful event and to enhance their chil-
drens coping outcomes.
Although there were no significant differences be-
tween the study groups with respect to the nurses
ratings of maternal involvement in the physical and
emotional care of the children in the PICU, the chil-
drens nurses, who were blinded with respect to
study group, rated the COPE mothers as being sig-
nificantly more involved in their childrens care in
the pediatric unit. Because of the short length of stay,
mothers in the COPE program might not have had
time to begin to demonstrate higher levels of in-
volvement in their childrens care, compared with
control mothers, in the PICU. In the first 2 days in the
PICU, children typically undergo numerous treat-
ments and tests, which may not create an environ-
ment in which parents feel at ease in performing
multiple parenting activities. Findings from earlier
studies support this reasoning; emergency admission
of a child to the PICU produces a major loss of
parenting roles for parents, which is a major source
of stress for them. However, after transfer to the
TABLE 5. Child Adjustment Outcomes
Outcome Cope Group Control Group F Effect Size*
N Mean (SD) N Mean (SD)
Child adjustment outcomes
BASC scores
Behavior symptoms composite
Time 4 72 291.3 (39.4) 56 288.5 (43.1) .16 .07
Time 7 49 291.2 (52.5) 40 307.7 (69.1) 1.69 .27
Time 8 55 294.2 (44.3) 34 299.6 (59.9) .25 .11
Time 9 42 288.8 (47.5) 25 320.5 (72.9) 4.48 .54
Externalizing behaviors
Time 4 73 98.6 (18.2) 57 98.8 (19.5) .005 .07
Time 7 49 99.6 (20.8) 41 107.9 (28.2) 2.68 .34
Time 8 55 100.0 (17.7) 34 103.6 (27.5) .51 .17
Time 9 43 97.3 (18.8) 25 111.6 (28.3) 5.94 .62
* Small effect size .20; medium effect size .50; large effect size .80.
BASC baseline score that reflects parents report of their childrens adjustment over the 3 months period prior to the sudden
hospitalization.
P .05.
P .01.
P .05 with multiple imputation analysis.
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pediatric unit, mothers in the COPE program re-
ceived a booster intervention that suggested strate-
gies regarding how they could continue to partici-
pate in their childrens care, as well as activities to
perform with their children that could enhance the
childrens adjustment. As a result, according to con-
trol theory,
13
barriers to parent participation were
most likely removed, so that these mothers could
provide more physical and emotional care to their
children.
With respect to PTSD symptoms, there was a trend
for COPE mothers to report fewer symptoms 6
months after discharge, which led to a greater diver-
gence of PTSD scores between the 2 study groups 12
months after discharge and resulted in a statistically
significant difference. These differences may be re-
lated to the fact that COPE mothers reported less
parental stress during hospitalization and partici-
pated more generally in their childrens emotional
and physical care, compared with control mothers.
Therefore, the experience might not have been as
stressful for them. The role that a person has in a
traumatic experience is a major factor that increases
the likelihood of developing PTSD.
31
Specifically, a
previous study found that parents whose children
underwent bone marrow transplantation might ex-
perience PTSD, largely because of their being unable
to be as supportive to their children and as actively
involved in their care as they were during outpatient
treatments, with high stress levels and feelings of
helplessness.
5
Those investigators hypothesized that
loss of parental roles might be a factor contributing
to the development of PTSD among parents whose
children undergo bone marrow transplantation. The
COPE mothers in this study were more involved in
their childrens care in the pediatric unit than were
the control parents, which might explain why the
former experienced fewer PTSD symptoms after the
experience. In addition, COPE mothers were able to
anticipate their childrens emotions and behaviors,
which might aid in decreasing uncertainty and feel-
ings of helplessness.
Overall, the findings from this study indicated that
children of mothers who received the COPE program
exhibited significantly fewer adjustment problems
with time, compared with children of mothers in the
control group. Although they were not statistically
significant, small positive effects of the COPE pro-
gram were noticeable 3 months after hospitalization.
At the 6-month follow-up assessments, COPE moth-
ers reported fewer clinically significant behavioral
symptoms and withdrawal symptoms, compared
with control mothers. Twelve months after dis-
charge, COPE mothers rated their children signifi-
cantly lower in hyperactivity and higher in adapt-
ability, compared with control mothers. These are
very important clinical findings, because there is ev-
idence that children who have been hospitalized in
critical care units are at higher risk for psychologic
trauma and/or behavior problems that demand psy-
chiatric attention, compared with other hospitalized
pediatric patients.
3
As hypothesized, COPE mothers
experienced improved maternal functional and emo-
tional coping outcomes, which resulted in fewer
child adjustment problems.
With the increasing prevalence of attention-defi-
cit/hyperactivity disorder and externalizing prob-
lems among children and the documented lack of
mental health screening and early intervention ser-
vices for children in this country,
32,33
our COPE in-
tervention could help protect this high-risk popula-
tion of children from developing these troublesome
problems. As a result, the mental health status of
children after critical care hospitalization could be
improved. In addition, family burdens and costs as-
sociated with the mental health treatment of these
problems might be substantially reduced.
A limitation of this clinical trial was the rate of
attrition through 12 months after discharge, which
presents a threat to the internal validity of the study.
Even with follow-up telephone calls, monetary in-
centives for completing questionnaires, repeated
mailings to the mothers after hospital discharge, and
cultural sensitivity training for research assistants,
attrition from the study was sizeable. For the method
used for follow-up assessment (ie, mailed question-
naires), however, the return rate was fairly typical.
34
Although there was no apparent relationship be-
tween the missing data and outcomes, overcoming
the challenge of obtaining posthospitalization fol-
low-up data with this high-risk population will be
essential for future studies. Home visits in which
data are obtained at regularly scheduled intervals
may be more successful than mailed questionnaires.
In our current intervention trial with high-risk par-
ents and low birth weight premature infants, testing
the effects of another version of the COPE program,
home visits have resulted in a substantially higher
subject retention rate and collection of long-term fol-
low-up data up to 2 years after hospital discharge.
CONCLUSIONS
This is the first full-scale, randomized trial to sup-
port the effectiveness of an efficient, easy-to-admin-
ister, reproducible intervention program for parents
of critically ill young children. On the basis of this
studys findings and the accumulating evidence of
the benefits of our similar intervention programs
with parents of hospitalized children and premature
infants,
6,23,27,35
the COPE program should be pro-
vided routinely to parents of young children admit-
ted unexpectedly to the PICU. Future research is
needed to determine 1) the cost-effectiveness of the
COPE intervention, 2) whether its effects can be
strengthened by including fathers, 3) whether its
effects can be strengthened with additional interven-
tion sessions 1 and 3 months after hospital discharge,
and 4) whether similar positive effects can be ob-
tained if the program is delivered to parents of
younger and older children and parents whose crit-
ically ill children have chronic and/or terminal con-
ditions.
ACKNOWLEDGMENTS
This research was supported by the National Institutes of
Health, National Institute of Nursing Research grant R01-
NR04174.
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Special thanks go to Zendi Moldenhauer, MS, RN, and Nancee
Bender, PhD, RN, for assistance with this research.
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