- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03361787
A Multi-dimensional Program for Parents of Adolescents With High-functioning Autism
Efficacy of a Multi-dimensional Program for Parents of Adolescents With High-functioning Autism
The purpose of this pilot study is to examine the initial efficacy of a multi-dimensional coaching intervention ("Parentship") for parents of adolescents with High Functioning Autism (HFASD).
The "Parentship" protocol is a short-term intervention program in occupational therapy that aims to promote parental resilience and enhance adolescents' participation in daily life.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
"Parentship" is a structured occupational therapy intervention for promoting parental resilience and enhance adolescents' participation in daily life The Parentship protocol uses OPC (Graham & Rodger, 2010) as the primary treatment approach. Its primary goal is to lead parents into recognition and understanding of their adolescent's multi-dimensional personal profile that includes sensorimotor, cognitive-behavioral, and social-communicative and personal factors, as required by the International Classification of Functioning (ICF) model (WHO, 2007).
The intervention will be administered by occupational therapists on an individual (or both parents) basis, once a week, over 3-4 months.
10-15 families will be recruited through community advertising. Data will be collected at the onset and completion of the intervention. Data will be analysed using quantitative and qualitative methods.
Adverse events, if occur, will be reported to supervising neurologist and the Helsinki Committee.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Jerusalem, Israel
- Hadassah medical organization, Jerusalem Israel
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ASD diagnosed by certified medical practitioner
- parent report regarding barriers to occupational performance/participation
- SP2 or BRIEF-Parent or SSIS scores reflecting at least 1 SD from typical
Exclusion Criteria:
- Diagnoses of severe neurological or psychiatric health condition.
- Instability in pharmacological treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Parentship coaching intervention
|
"Parentship" is a multi dimensional intervention program to improve parental resilience and adolescent participation using the OPC model.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Canadian Occupational Performance Measure (COPM)
Time Frame: 3-4 months
|
structured interview administered by occupational therapist
|
3-4 months
|
Autism: Parenting Questionnaire (APQ)
Time Frame: 3-4 months
|
7 dimensions (Knowledge About Autism, Communication, Play, Behaviour Management, Confidence, Stress Management, and Family Functioning) are the focus of this questionnaire that serves as a basis for intervention with parents
|
3-4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Assessment of Therapeutic Responses (CATR)
Time Frame: 1.5 months and 3 months
|
a questionnaire that monitors the abilities of the therapist to create an optimal parent-therapist relationship
|
1.5 months and 3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0269-17-HMO-CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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