A Multi-dimensional Program for Parents of Adolescents With High-functioning Autism
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
"Parentship"- a multi dimensional intervention program to improve parental resilience
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring adolescents, parents, coaching
Eligibility Criteria
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
Sites / Locations
- Hadassah medical organization, Jerusalem Israel
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Parentship coaching intervention
Arm Description
Outcomes
Primary Outcome Measures
Canadian Occupational Performance Measure (COPM)
structured interview administered by occupational therapist
Autism: Parenting Questionnaire (APQ)
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
Secondary Outcome Measures
Clinical Assessment of Therapeutic Responses (CATR)
a questionnaire that monitors the abilities of the therapist to create an optimal parent-therapist relationship
Full Information
NCT ID
NCT03361787
First Posted
November 29, 2017
Last Updated
February 10, 2021
Sponsor
Hadassah Medical Organization
Collaborators
Hebrew University of Jerusalem
1. Study Identification
Unique Protocol Identification Number
NCT03361787
Brief Title
A Multi-dimensional Program for Parents of Adolescents With High-functioning Autism
Official Title
Efficacy of a Multi-dimensional Program for Parents of Adolescents With High-functioning Autism
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
August 15, 2019 (Actual)
Study Completion Date
September 24, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization
Collaborators
Hebrew University of Jerusalem
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
adolescents, parents, coaching
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parentship coaching intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
"Parentship"- a multi dimensional intervention program to improve parental resilience
Intervention Description
"Parentship" is a multi dimensional intervention program to improve parental resilience and adolescent participation using the OPC model.
Primary Outcome Measure Information:
Title
Canadian Occupational Performance Measure (COPM)
Description
structured interview administered by occupational therapist
Time Frame
3-4 months
Title
Autism: Parenting Questionnaire (APQ)
Description
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
Time Frame
3-4 months
Secondary Outcome Measure Information:
Title
Clinical Assessment of Therapeutic Responses (CATR)
Description
a questionnaire that monitors the abilities of the therapist to create an optimal parent-therapist relationship
Time Frame
1.5 months and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hadassah medical organization, Jerusalem Israel
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Multi-dimensional Program for Parents of Adolescents With High-functioning Autism
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