- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04107792
Parental Sense of Competence Workshops for Parents of Children With Sensory Processing Issues
February 8, 2020 updated by: Yani Hamdani, PhD, Holland Bloorview Kids Rehabilitation Hospital
The Impact of an Education Workshop on Parental Sense of Competence
The primary objective of this pilot randomized waitlist control trial is to evaluate the impact of an OT-led parent education workshop on the PSOC of parents of children experiencing SPIs who are on the waitlist for a neurodevelopmental diagnostic assessment.
The secondary objective is to obtain a subjective evaluation of the content, format, and delivery of the parent education workshop from the parents' perspectives.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Introduction.
Parents of children with sensory processing issues (SPIs) experience decreased levels of parental sense of competence (PSOC) in managing SPI-related behaviours that challenge conventional parenting skills.
Occupational therapy (OT)-led parent education workshops (PEWs) have been found to increase the PSOC of parents of children with SPIs who have a formal Autism Spectrum Disorder (ASD) diagnosis.
However, research is limited on how these interventions affect PSOC of parents of children with SPIs who do not have a formal diagnosis, and are still on the waitlist for a neurodevelopmental assessment.
This is vital as children with SPIs and their parents may have limited access to specialist referrals, government-funded interventions, or support services while they await a diagnostic assessment.
SPI-related workshops may provide an opportunity to support families and promote PSOC and well-being by providing strategies to address SPI-related behaviours while they wait (which may be beneficial regardless of whether their child eventually receives a formal neurodevelopmental diagnosis or not).
Objectives.
The primary objective of this pilot randomized waitlist control trial is to evaluate the impact of an OT-led parent education workshop on the PSOC of parents of children experiencing SPIs who are on the waitlist for a neurodevelopmental diagnostic assessment.
The secondary objective is to obtain a subjective evaluation of the content, format, and delivery of the parent education workshop from the parents' perspectives.
Methods.
Parents will be recruited from the waitlist for a neurodevelopmental assessment for their children through the "Communication, Learning, and Behaviour" clinic at Holland Bloorview Kids Rehabilitation Hospital.
Participants will be randomly selected to attend one of two identical workshops scheduled two weeks apart.
The PSOC Scale, along with demographics and follow-up questionnaires that include both closed and open-ended questions, will be administered to parents pre- and post-workshop attendance.
Descriptive statistics, an independent sample t-test and a two-way Analysis of Variance (ANOVA) will be used to analyze quantitative data from these outcome measures.
To analyze the qualitative data (parents' open ended responses on the follow-up feedback questionnaire), a content analysis will be completed, which will be used to complement the quantitative results, as well as provide feedback regarding the content, format, and delivery of the parent education workshop.
Practice Implications.
Results from this study can provide evidence to support the need for parent education workshops in improving the PSOC of parents of children on the waitlist for a neurodevelopmental assessment, promote mental health and wellbeing of parents while they wait for the assessment, promote parenting that helps children with SPIs engage in daily life occupations, and inform the development of future workshops.
Conclusion.
Information garnered from this study can inform the development of OT services that can address the current gap in care while parents and their children with SPIs are waiting for a formal neurodevelopmental assessment and referrals to publicly funded services funded for specific diagnosis.
Study Type
Interventional
Enrollment (Anticipated)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4G 1R8
- Recruiting
- Holland Bloorview Kids Rehabilitation Hospital
-
Contact:
- Yani Hamdani
- Phone Number: 4169780528
- Email: y.hamdani@utoronto.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Parents of children with Sensory Processing Issues
- On the waitlist for a neurodevelopmental diagnostic assessment at the "Communication, Learning, and Behaviour" clinic at Holland Bloorview Kids Rehabilitation Hospital
- At least 18 years of age or older
- Target child(ren) with SPIs must be between the ages of 0-17 years (which is the age restriction of the Parental Sense of Comptence scale)
- The child(ren)'s scheduled neurodevelopmental diagnostic assessment date must be after their final completion of the Parental Sense of Competence Scale (two weeks following workshop attendance) to control for any external influence that a formal diagnosis may have on participants' Parental Sense of Competence
- Basic English comprehension reading and writing skills
- Access to the internet
Exclusion Criteria:
- Previously attended a parent education workshop or intervention targeting Sensory Processing Issues
- Attend a different parent education workshop or intervention for Sensory Processing Issues throughout the duration of the current study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Experimental
Parents of children with sensory processing issues who attend Workshop 1
|
The intervention will be a two-hour parent education workshop that provides education and teaches parent-mediated strategies for managing children's behaviours associated with SPIs.
|
|
NO_INTERVENTION: Waitlist Control
parents of children with sensory processing issues who attend Workshop 2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parental Sense of Competence (PSOC) Scale
Time Frame: One Month
|
The Parental Sense of Competence (PSOC) scale is a self-report scale that measures and assesses parent self-efficacy on two dimensions: Satisfaction and Self-Efficacy.
It is a 17-item scale, with each item rated on a 6-point Likert scale, anchored by 1 = "Strongly Disagree" and 6 = "Strongly Agree".
Nine (9) items (#2, 3, 4, 5, 8, 9, 12, 14, 16) on the PSOC are reverse coded.
Once reverse coded, the score for each item is added up to give the "total score" for this scale.
The minimum and maximum total scores (total range) are 17 and 102, respectively.
No subscale scores are reported.
A higher total score indicates a higher parenting sense of competency; a lower total score indicates a lower parenting sense of competency.
There are no average scores or "cut offs" for this tool.
|
One Month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Yani Hamdani, PhD, University of Toronto
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
January 31, 2020
Primary Completion (ANTICIPATED)
September 30, 2020
Study Completion (ANTICIPATED)
September 30, 2020
Study Registration Dates
First Submitted
September 26, 2019
First Submitted That Met QC Criteria
September 26, 2019
First Posted (ACTUAL)
September 27, 2019
Study Record Updates
Last Update Posted (ACTUAL)
February 11, 2020
Last Update Submitted That Met QC Criteria
February 8, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- SPIStudy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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