PARTICIPANT INFORMATION SHEET AND INFORMED CONSENT FORM

University of Santo Tomas

College of Rehabilitation Sciences

PARTICIPANT’S INFORMATION AND INFORMED CONSENT FORM

FOR OCCUPATIONAL THERAPISTS

Research Study Title: A Cross-Cultural Adaptation of the Revised Knox Preschool Play Scale
for Filipino Children
Institutional Affiliation: University of Santo Tomas
Department: Department of Occupational Therapy
Faculty Researchers: Paulin Grace Morato-Espino, OTRP, PhD (Cand.)
Student Researchers: Chiu, Bea Angelina; Berdijo, Lina Lou; Caparas, Angela Veronica;
Hilario, Monina Angeli; Leoncio, Czarina Jae; Soliven, Mary Katherine; Versoza, Aaron Jan
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Participant Information Sheet

Dear Participants,

Greetings!

We are 5th year BS Occupational Therapy students from the University of Santo Tomas -
College of Rehabilitation Sciences (UST-CRS), and we are currently undertaking a study
entitled “A Cross-Cultural Adaptation of the Revised Knox Preschool Play Scale for Filipino
Children” which aims to provide a cross-cultural adaptation of the RKPPS for Filipino children,
establish the content validityof the adapted tool, and establish intra-rater reliability and inter-
rater reliability of the culturally validated tool.

We are inviting you to be part of our study and in line with the requirements of the ethics
committee of UST-CRS, we provide you this consent form to give you an idea of what our
research is all about, what we expect of you, and what you should expect from us. This will also
serve as proof of your voluntary consent with full intent and knowledge of the content of our
study to participate in our study. . You will be given a copy of the signed and dated written forms
prior to your participation in the study. All information after the introduction will be presented in a
“second-person” point of view to help you better understand the text.

Please take your time to thoroughly read through all the information presented hereafter. For
more information about our study, feel free to ask any of the researchers.

Purpose of the study:

The RKPPS is an observational play assessment tool used to

determine a child’s

Valid until October 2018

developmental status. The purpose of this study is to culturally adapt the Revised Knox
Preschool Play Scale (RKPPS) in order to make it relevant for the Filipino population. Once
cultural adaptation has been performed, its psychometric properties will be established in order
to ensure accuracy and reproducibility of the results. Performing a cultural adaptation of the
RKPPS will provide occupational therapists in the Philippines a better means to objectively
evaluate a child’s development.

Procedure:

The researchers have sought approval from the University of Santo Tomas - College of
Rehabilitation Sciences Ethics Review Committee (UST-CRS ERC) to ensure the rights and
safety of the participants. The authorities of the UST-CRS ERC will be granted direct access to
the participant’s medical records ONLY for the purpose of verification of procedures and data.

Recruitment Criteria
The researchers will be inviting 40 occupational therapists to participate in the study. You have
been selected to be part of the study primarily because of your expertise and because you may
possibly meet the following requirements:
 Licensed pediatric occupational therapist

 Practicing for at least 2 years in the pediatric setting

 No prior experience in using the Revised Knox Preschool Play Scale

Procedures
To achieve the objectives, the study will undergo three phases: (1) Cultural Validation, (2) Pilot-
testing and (3) Establishing intra-rater and inter-rater reliability. The occupational therapists will
be important in Phases 2 and 3 of the study.

Phase 1 involves the cultural validation of the RKPPS through an expert panel review. Experts
will be recruited to evaluate the cultural equivalence and relevance of the items of the
assessment tool. They will be providing comments and suggestions as to how items can be
revised to make it relevant for the Filipino population. Revisions will be made and the expert
panel committee will be rating the revised tool on a 4-point likert scale: 1 = not relevant, 2 =
unable to assess relevance, 3 = relevant but needs minor alterations and 4 = highly relevant.
Items classified as 1 or 2 should be re-evaluated and revised. This will produce the pre-final
version of the culturally adapted assessment tool.

Phase 2 involves the pilot-testing of the pre-final version of the tool. In this phase, your role will
be to rate the pre-final version of the tool on a dichotomous scale (relevant or irrelevant). For
any items you will be rating as irrelevant, you will be asked to provide suggestions as to how to
revise the item to make it relevant. Any items found to be irrelevant by 20% of the OTs will be
re-evaluated and once again revised by the expert panel committee. The same procedures
mentioned above will be conducted until all the items are rated as relevant by 80% of the OTs.

Valid until October 2018

This process will then produce the final version of the tool which will be used to establish intra-
rater and inter-rater reliability of the said tool.

Once all the items have been rated as relevant, the study will proceed to phase 3 wherein you
will be asked to watch and rate videos of children in two settings – one indoors and one
outdoors. The videos will last for 45 minutes each; the first 15 minutes will serve as a warm-up
period, and you will start rating the child at the 15 minute mark until the end. To establish intra-
rater reliability, you will be asked to rate the same videos after a wash-out period of at least 48
hours. To establish inter-rater reliability, we will just be comparing the scores you obtained with
the scores obtained by other occupational therapists.

Please be informed that for your convenience, the scale and the video recordings will be sent to
you via e-mail or uploaded privately online.

Data Management

All the data and information sheets collected during the study will be stored in a storage box
with a lock. Results from the assessment tool will be encoded in Microsoft Excel using codes (ID
numbers) to ensure the anonymity of the child. The file will be stored in a storage application
with a passcode.

Video recording of the children will be uploaded privately or sent via e-mail to the occupational
therapists who will be rating them. These videos will be copyrighted by placing a statement
which emphasizes that the video will solely be used for the purpose of the study.

All the data gathered will be appropriately disposed once the study has been completed. Hard
copies of the data sheets will be shredded and the soft copy of the files of the videos will be

deleted.

Safety Measures
Phase 2 and 3 poses minimal safety hazards. However, to prevent eye strains from watching a
lengthy video while rating, you may opt to skip to the 15-minute mark of the video as rating will
only commence on that period. You may also opt to take rest break in between when
necessary.

Benefits:
The study will be beneficial for occupational therapists as this paves an opportunity to create
better play assessments which may help identify skills and deficits for children in the Philippine
context. Assessment of play can help the therapists determine eligibility for services for children
with special needs, facilitate intervention planning and understand a child’s preferences.

Valid until October 2018

Risks and Inconvenience:
The study will be requiring approximately an hour of your time to rate the items on a
dichotomous scale and another hour to watch and rate the videos of the children. To minimize
inconveniences, we will be sending you the videos privately for you to be able to rate them at a
time where it is most convenient for you.

Compensation:
Compensations for your participation in our study will be provided. The researchers will be
willing to compensate for your professional fee as you will be spending time examining the
child’s play participation through a video recording. The researchers will also be providing
acknowledgments for your participation in the study.

Voluntariness:
Please be assured that it is upon your discretion to participate in the study. If you agree to
participate in the study, you will be allowed to withdraw at any point of the study without any loss
of benefits. Your decision will be accepted with utmost respect. An informed consent form will
be given to ensure that your decision will be properly documented.

Confidentiality:
The researchers assure you that all the data and information gathered during the study will be
kept confidential and will be used for the sole purpose of this study.

Contact Persons:
If you have any questions regarding our study, feel free to contact any of the following persons:
Name Contact details
Chiu, Bea Angelina 09333580677
Berdijo, Lina Lou 09275088766
Hilario, Monina
Angeli 09276728559

For any questions about your rights as participants of this study, you may contact the head of
the UST-College of Rehabilitation Sciences Ethics Review Committee, Dr. Anna Lea Enriquez,
at 7409713 or ustcrs.erc@gmail.com.You may find her at Room 101 Medicine Building,
University of Santo Tomas Espana Boulevard, Manila, 1015 on Mondays – Fridays from 8:00
am – 5:00 pm.

Injury Statement:
For any incidences wherein you have acquired injuries as a result of participation in the study,
the researchers will shoulder all medical expenses for the treatment of the injury.

Valid until October 2018

 CONSENT FORM FOR OCCUPATIONAL THERAPISTS

I have read and understood the above information and have been given the opportunity to
consider and ask questions on the information regarding my involvement in this study. I have
spoken directly to the investigator/s of this study who has/have answered to my satisfaction all
my questions. I have received a copy of this Participant’s Information and Informed Consent
Form and hereby voluntarily agree to be part of the study.

Participant’s Signature:
(Thumb Print needed only if the participant cannot write)

_______________________ ______________________ ________________

Printed Name of Participant Signature of Participant Date

Left Thumb Right Thumb

Guardian’s Signature:

______________________ ____________________ ________________

Printed Name of Legal Guardian Signature of Legal Guardian Date
(If applicable)

Witness:

______________________ ___________________ ________________

Printed Name of Witness Signature of Witness Date

I have presented and explained to _______________________________________ the

purpose of the research, the procedures that are involved, as well as the possible benefits and
risks with the study, to the best of my knowledge and ability

___________________________________ ________________
Signature over printed name of investigator Date

Valid until October 2018