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University of Santo Tomas

College of Rehabilitation Sciences


PARTICIPANT’S INFORMATION AND INFORMED CONSENT FORM
(FOR OCCUPATIONAL THERAPISTS FORWARD TRANSLATING THE SPSRC INTO TAGALOG)
Research Study Title: Examining the psychometric properties of the Sensory Processing and
Self-Regulation Checklist Tagalog version
Institutional Affiliation: University of Santo Tomas
Department: Department of Occupational Therapy
Faculty Researchers: Ivan Neil B. Gomez, OTRP, OT, OTR, MAED, PhD (cand)
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Participant Information Sheet
Dear Participant,
Greetings!
I am Ivan Neil Gomez, a researcher from the Center for Health Research and Movement
Sciences of University of Santo Tomas – College of Rehabilitation Sciences (UST-CRS), and I am
currently undertaking a study entitled “Examining the psychometric properties of the Sensory
Processing and Self-Regulation Checklist- Tagalog version” which aims to translate and examine
the reliability and validity of the Sensory Processing and Self-Regulation Checklist- Tagalog
version.
I am inviting you to be part of the study and in line with the requirements of the Ethics Review
Committee of UST-CRS, I provide you this consent form to give you an idea of what my research
is all about, what we expect of you, and what you should expect from me. This will also serve
proof of your voluntary consent with full intent and knowledge of the content of my 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.
Purpose of the study:
The Sensory Processing and Self-Regulation Checklist (SPSRC) is a caregiver-answered
questionnaire that aims to ascertain the self-regulation functions and sensory processing of
children ages 3-8 years old. The purpose of this study is to translate the SPSRC into Tagalog, and
examine it reliability and validity.
Procedure:
The researcher has 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
This research will be inviting several participants to answer several research objectives. Specific
to this study phase, one professional will perform forward translation of the tool. 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 professional (at least 5 years continued practice within the recent years) having
knowledge on sensory processing and/ or self-regulation (i.e. Occupational Therapist,
Physical Therapist, Speech-Language Pathologist)
 Knowledgeable in the Asian culture with proficiency in English language and written
texts;
 Tagalog is the mother tongue;
 Has worked with children with disabilities;
 Has worked primarily in Metro Manila for >5 years;
 Has a history of continuing professional education related to sensory processing and/or
self-regulation.
Procedures
To achieve the objectives, the study will undergo three phases: (1) Translation, (2) Pilot Testing
and (3) Field Testing. As an occupational therapist, your role is valuable in this study.
Phase 1 of the study entails several steps. Specific to your expertise, you are invited to forward
translate the SPSRC into Tagalog (from its current English translation version) which also
includes adaptation of the items into the Filipino culture. There are 130 items in the
questionnaire, divided into two parts. Part 1 tests self-regulation ability and Part 2 tests sensory
processing ability. Part 1 consist of three scales: (1) physiological, (2) social/cognitive/emotional
and (3) facing changes or challenges. Part 2 consists of six scales: (1) auditory, (2) visual, (3)
tactile, (4) gustatory/olfactory, (5) vestibular and (6) proprioceptive. The parents are required
to report their child’s typical condition during the previous 3 months on a 5-point Likert scale
(never= 5, seldom = 4, sometimes = 3. most of the time = 2, always =1; opposite polarity in
some items).
Please be informed that for your convenience, the questionnaire and further correspondence
as needed will be done by e-mail or uploaded privately online.
Data Management
All the hard copies of the data, information sheets and documents collected during the study
will be stored in a storage box with a lock. Soft copies will be kept by the researcher in a
password-encoded storage disk and cloud drive. Results from the assessment tool will be
encoded in Microsoft Excel using codes (ID numbers) to ensure the anonymity of the
participant. 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 will be
deleted after a period of 5 years.

Safety Measures
The procedures entailed in this research study poses minimal to no safety hazard. Participants
are advised to take rests in between answering the questionnaires. Furthermore, participants
are given ample time (1-2 weeks to complete the questionnaires)

Benefits
The study will be beneficial for occupational therapists as this paves an opportunity to create
better assessments which may help identify skills and deficits for children in the Philippine
context. Assessment of self-regulation and sensory processing can help health-care
professionals determine eligibility for services for children with special needs, facilitate
intervention planning and understand a child’s performance in daily activities. Other than this,
participants will be given a summary of the results of the assessment based on the
questionnaires they answered, consultation with an OT professional as necessary, and a
pamphlet about child development and parenting.

Risks and Inconvenience


For the professionals: The study will be requiring approximately ten hours of time to evaluate
the translations of the items. To minimize inconveniences, we will conduct the procedures via
online and when it is most convenient for them.
For the parents: The study will be requiring approximately four hours of time to evaluate the
translations of the items. To minimize inconveniences, we will commence the procedures that
are most convenient for you with ample time to complete the questionnaires.

Compensation
Compensations for participation in this study can be provided. The researcher is willing to
compensate for the professional fee in time translating and evaluating the SPSRC-Tagalog. The
researchers will also be providing acknowledgments for participation in the study. Parents will
be given free assessment and consultation (as necessary) in the form of summary results based
from the questionnaires they answered.

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

Confidentiality
The researcher assures participants 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.

Plan for Dissemination of Results


Once data gathering has been completed (i.e. meeting the required sample size ample for
statistical analysis), participants will be contacted via email or SMS message that the availability
of the study results will be posted on trial registry from which this research project will apply to
(ClinicalTrials.gov). A short summary of the results will likewise be made available and mailed to
the participants, and made publicly available in a website that will developed to contain the
information about the research project. Likewise participants will be informed by way of email,
post or SMS of this.

Contact Persons
If you participants have any questions regarding our study, feel free to contact the following
person: Ivan Neil B. Gomez: +639177034993 or ibgomez@ust.edu.ph.
For any questions about their rights as participants of this study, they are instructed to contact
the head of the UST-College of Rehabilitation Sciences Ethics Review Committee, Dr. Anna Lea
Enriquez, at 7409713 or ustcrs.erc@gmail.com. They 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 the participants have acquired injuries as a result of direct
participation in the study, the researcher will shoulder all relevant medical expenses for the
treatment of the injury.

CONSENT FORM FOR OCCUPATIONAL THERAPISTS FORWARD TRANSLATING THE SPSRC INTO
TAGALOG
I have read and understood the above information and have been given the opportunity to
consider and ask question 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:
_____________________ _____________________ __________________
Printed Name of Participant Signature of Participant Date
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

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