The Effectiveness of OT-ParentShip on Parental Resilience and Functioning of Adolescents With High Functioning Autism

May 18, 2023 updated by: Meir Medical Center

The goal of this clinical trial is to evaluate the efficacy of the OT (Occupational Therapy)-ParentShip intervention program for parents of adolescents with Autism. A mixed method, two group, randomized controlled trial (RCT). Forty participants will be recruited through convenience sampling and will be randomly assigned to one of two groups: an OT-ParentShip intervention group or a psycho-educational intervention group.

The main questions it aims to answer are:

  • Which baseline characteristics will predict positive treatment outcomes (based on the outcome measures defined)?
  • What is the parents' perception and experience from the intervention process and its outcomes?

The course of intervention in each group:

OT-ParentShip group: each family will participate in a series of 11 individual weekly sessions of 90 minutes each and another session after three months from the end of the intervention. Control group: Each family will receive a general, psycho-educational, video-based intervention.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Parents of adolescents with Autism Spectrum Disorder (ASD) are at risk for low parental competence and decreased sense of autonomy, facing challenges in parent-child relationships. Moreover, parents of children with High Functioning ASD (HFASD) experience significantly higher levels of parental stress in comparison to parents of typically developing children. A range of body functions is associated with occupational challenges in ASD, such as sensory, cognitive, social-communicative and emotional. Occupation based interventions consistent with Self-Determination Theory (SDT) principles were found to promote parental competence and improve participation of children with ASD. However, there is a need for multidimensional interventions that address both the adolescents' occupational challenges and underlying body functions, as well as parents' psychological needs. OT (Occupational Therapy)-ParentShip is an intervention program for parents of adolescents with HFASD which includes an integrative multidimensional approach to the multiple factors involved in the functioning of adolescents with HFASD and aims to promote parental resilience and enhance adolescents' participation.

Preliminary results: a mixed methods pilot study (N=10) was conducted to evaluate the feasibility of the OT-ParentShip. Significant improvements were found in parents' and adolescents' functional goals, as well as improvement in parental resilience. In addition, six themes were identified, shedding light on the therapeutic components and change mechanisms of OT-Parentship.

Study Type

Interventional

Enrollment (Estimated)

50

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 Contact

Study Contact Backup

Study Locations

  • Israel
      • Jerusalem, Israel
        • Recruiting
        • The Hebrew University of Jerusalem

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Phase A:

  • Parents (father, mother or both) of an adolescent (male or female) aged 12- 18, who is a student in junior or high school.
  • Medical diagnosis (by a neurologist or psychiatrist) of a HFASD (Level 1) according to the criteria of DSM-5 or DSM-IV.
  • Parents report regarding unmet functional needs / difficulties.
  • Signed consent of at least one parent to attend all sessions for a period of approximately 13 weeks.

Phase B:

• Receiving a score that defines disability in at least one of the following areas: sensory processing / executive function / social-communication skills.

Exclusion Criteria:

  • Unbalanced neurologic or psychiatric comorbidity with HFASD, having a major effect on functioning, based on parental report.
  • Parents who are unable or unavailable (emotionally or for any other reason) to participate in the intervention or the implementation (based on self-report).

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: An OT-ParentShip intervention
Each family will participate in a series of 11 individual weekly sessions of 90 minutes each and another session after three months from the end of the intervention.
Other: Parent intervention
Family centered, strength-based, Occupational therapy intervention program
Other: A psycho-educational intervention group.
Each family will receive a general, psycho-educational, video-based intervention. The program includes 6 videos with an average length of 20 minutes each.The participants are asked to watch the video according to the order once every two weeks.
Other: Parent intervention
Family centered, strength-based, Occupational therapy intervention program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autism: Parenting Questionnaire (APQ) (Kim, Anderson, Birkin, Seymour, & Moore, 2004).
Time Frame: Before intervention (Time 1)
A self-completed questionnaire which surveys parents on six domains of autism-specific parenting competence (knowledge, communication, play, behavior management, security and family functioning) and one domain of parenting stress.
Before intervention (Time 1)
Basic Psychological Need Satisfaction in Relationships (La Guardia, Ryan, Couchman, & Deci 2000).
Time Frame: Before intervention (Time 1)
This questionnaire used in order to assess the degree to which a person experiences basic need satisfaction while relating to his or her spouse, best friend, mother, children, or whomever.
Before intervention (Time 1)
Canadian Occupational Performance Measure (COPM)- Parent (Law, Baptiste, Carswell, McColl, Polatajko, & Pollock, 1998)
Time Frame: Before intervention (Time 1)
A semi-structured interview, used as an outcome measure to detect changes in self-perception of patient performance and satisfaction over time by identifying problems with daily functioning.
Before intervention (Time 1)
Autism: Parenting Questionnaire (APQ) (Kim, Anderson, Birkin, Seymour, & Moore, 2004).
Time Frame: Immediately post intervention (Time 2)
A self-completed questionnaire which surveys parents on six domains of autism-specific parenting competence (knowledge, communication, play, behavior management, security and family functioning) and one domain of parenting stress.
Immediately post intervention (Time 2)
Basic Psychological Need Satisfaction in Relationships (La Guardia, Ryan, Couchman, & Deci 2000).
Time Frame: Immediately post intervention (Time 2)
This questionnaire used in order to assess the degree to which a person experiences basic need satisfaction while relating to his or her spouse, best friend, mother, children, or whomever.
Immediately post intervention (Time 2)
Canadian Occupational Performance Measure (COPM)- Parent (Law, Baptiste, Carswell, McColl, Polatajko, & Pollock, 1998)
Time Frame: Immediately post intervention (Time 2)
A semi-structured interview, used as an outcome measure to detect changes in self-perception of patient performance and satisfaction over time by identifying problems with daily functioning.
Immediately post intervention (Time 2)
Autism: Parenting Questionnaire (APQ) (Kim, Anderson, Birkin, Seymour, & Moore, 2004).
Time Frame: Three months post intervention (follow-up-Time 3).
A self-completed questionnaire which surveys parents on six domains of autism-specific parenting competence (knowledge, communication, play, behavior management, security and family functioning) and one domain of parenting stress.
Three months post intervention (follow-up-Time 3).
Basic Psychological Need Satisfaction in Relationships (La Guardia, Ryan, Couchman, & Deci 2000).
Time Frame: Three months post intervention (follow-up-Time 3).
This questionnaire used in order to assess the degree to which a person experiences basic need satisfaction while relating to his or her spouse, best friend, mother, children, or whomever.
Three months post intervention (follow-up-Time 3).
Canadian Occupational Performance Measure (COPM)- Parent (Law, Baptiste, Carswell, McColl, Polatajko, & Pollock, 1998)
Time Frame: Three months post intervention (follow-up-Time 3).
A semi-structured interview, used as an outcome measure to detect changes in self-perception of patient performance and satisfaction over time by identifying problems with daily functioning.
Three months post intervention (follow-up-Time 3).
Canadian Occupational Performance Measure (COPM)- Parent (Law, Baptiste, Carswell, McColl, Polatajko, & Pollock, 1998)- Transfer goal
Time Frame: Immediately post intervention
A semi-structured interview, used as an outcome measure to detect changes in self-perception of patient performance and satisfaction over time by identifying problems with daily functioning.
Immediately post intervention
Canadian Occupational Performance Measure (COPM)- Parent (Law, Baptiste, Carswell, McColl, Polatajko, & Pollock, 1998)- Transfer goal
Time Frame: Three months post intervention
A semi-structured interview, used as an outcome measure to detect changes in self-perception of patient performance and satisfaction over time by identifying problems with daily functioning.
Three months post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Canadian Occupational Performance Measure (COPM)-Adolescent (Law, Baptiste, Carswell, McColl, Polatajko, & Pollock, 1998)
Time Frame: Before intervention (Time 1)
A semi-structured interview, used as an outcome measure to detect changes in self-perception of patient performance and satisfaction over time by identifying problems with daily functioning.
Before intervention (Time 1)
Canadian Occupational Performance Measure (COPM)-Adolescent (Law, Baptiste, Carswell, McColl, Polatajko, & Pollock, 1998)
Time Frame: Immediately post intervention (Time 2)
A semi-structured interview, used as an outcome measure to detect changes in self-perception of patient performance and satisfaction over time by identifying problems with daily functioning.
Immediately post intervention (Time 2)
Canadian Occupational Performance Measure (COPM)-Adolescent (Law, Baptiste, Carswell, McColl, Polatajko, & Pollock, 1998)
Time Frame: Three months post intervention (follow-up-Time 3)
A semi-structured interview, used as an outcome measure to detect changes in self-perception of patient performance and satisfaction over time by identifying problems with daily functioning.
Three months post intervention (follow-up-Time 3)
Canadian Occupational Performance Measure (COPM)-Adolescent (Law, Baptiste, Carswell, McColl, Polatajko, & Pollock, 1998)- Transfer goal
Time Frame: Immediately post intervention
A semi-structured interview, used as an outcome measure to detect changes in self-perception of patient performance and satisfaction over time by identifying problems with daily functioning.
Immediately post intervention
Canadian Occupational Performance Measure (COPM)-Adolescent (Law, Baptiste, Carswell, McColl, Polatajko, & Pollock, 1998)- Transfer goal
Time Frame: Three months post intervention
A semi-structured interview, used as an outcome measure to detect changes in self-perception of patient performance and satisfaction over time by identifying problems with daily functioning.
Three months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Collaborators

Hebrew University of Jerusalem

Investigators

  • Study Director: Batel Wachspress, MA, Hebrew University of Jerusalem

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

March 3, 2021

Primary Completion (Estimated)

May 1, 2023

Study Completion (Estimated)

September 1, 2023

Study Registration Dates

First Submitted

March 20, 2023

First Submitted That Met QC Criteria

May 18, 2023

First Posted (Actual)

May 30, 2023

Study Record Updates

Last Update Posted (Actual)

May 30, 2023

Last Update Submitted That Met QC Criteria

May 18, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0119-20-COM

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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