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

NCT05879705 | Unknown DMC

• 1 other identifier: 0119-20-COM
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism; RCT; Parent-intervention; Adolescents

Outcome Measures

Primary Outcomes (11)

• Autism: Parenting Questionnaire (APQ) (Kim, Anderson, Birkin, Seymour, & Moore, 2004).

  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).

  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)

  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).

  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).

  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)

  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).

  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).

  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)

  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

  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

  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 Outcomes (5)

• Canadian Occupational Performance Measure (COPM)-Adolescent (Law, Baptiste, Carswell, McColl, Polatajko, & Pollock, 1998)

  Before intervention (Time 1)

• Canadian Occupational Performance Measure (COPM)-Adolescent (Law, Baptiste, Carswell, McColl, Polatajko, & Pollock, 1998)

  Immediately post intervention (Time 2)

• Canadian Occupational Performance Measure (COPM)-Adolescent (Law, Baptiste, Carswell, McColl, Polatajko, & Pollock, 1998)

  Three months post intervention (follow-up-Time 3)

• Canadian Occupational Performance Measure (COPM)-Adolescent (Law, Baptiste, Carswell, McColl, Polatajko, & Pollock, 1998)- Transfer goal

  Immediately post intervention

• Canadian Occupational Performance Measure (COPM)-Adolescent (Law, Baptiste, Carswell, McColl, Polatajko, & Pollock, 1998)- Transfer goal

  Three months post intervention

Study Arms (2)

An OT-ParentShip intervention

EXPERIMENTAL

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

A psycho-educational intervention group.

OTHER

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

Interventions

Parent intervention OTHER

Family centered, strength-based, Occupational therapy intervention program

A psycho-educational intervention group.; An OT-ParentShip intervention

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Meir Medical Center: lead
• Hebrew University of Jerusalem: collaborator

Study Sites (1)

The Hebrew University of Jerusalem

Jerusalem, Israel

RECRUITING

Related Publications (1)

• Wachspress B, Maeir A, Mazor-Karsenty T. Content Validity of the Parentship Protocol: A Multidimensional Intervention for Parents of Adolescents with High-Functioning Autism Spectrum Disorder. Phys Occup Ther Pediatr. 2019;39(4):373-387. doi: 10.1080/01942638.2018.1500968. Epub 2018 Sep 6.

  PMID: 30188233 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Batel Wachspress, MA

  Hebrew University of Jerusalem

  STUDY DIRECTOR

Central Study Contacts

Shlomit Tsafrir, MD

CONTACT

0503255205; shtsafrir@gmail.com

Tal Mazor-Karsenty, PHD

CONTACT

0546387621; tal.mazor-karse@mail.huji.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A mixed method, two group, randomized controlled trial (RCT).

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: May 30, 2023
• Study Start: March 3, 2021
• Primary Completion: May 1, 2023
• Study Completion: September 1, 2023
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)