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

Primary Purpose

Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Parent intervention
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism, RCT, Parent-intervention, Adolescents

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • The Hebrew University of JerusalemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

An OT-ParentShip intervention

A psycho-educational intervention group.

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Canadian Occupational Performance Measure (COPM)-Adolescent (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.
Canadian Occupational Performance Measure (COPM)-Adolescent (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.
Canadian Occupational Performance Measure (COPM)-Adolescent (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.
Canadian Occupational Performance Measure (COPM)-Adolescent (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.
Canadian Occupational Performance Measure (COPM)-Adolescent (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.

Full Information

First Posted
March 20, 2023
Last Updated
May 18, 2023
Sponsor
Meir Medical Center
Collaborators
Hebrew University of Jerusalem
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1. Study Identification

Unique Protocol Identification Number
NCT05879705
Brief Title
The Effectiveness of OT-ParentShip on Parental Resilience and Functioning of Adolescents With High Functioning Autism
Official Title
The Effectiveness of OT-ParentShip on Parental Resilience and Functioning of Adolescents With High Functioning Autism
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
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
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism, RCT, Parent-intervention, Adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A mixed method, two group, randomized controlled trial (RCT).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
An OT-ParentShip intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
A psycho-educational intervention group.
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Parent intervention
Intervention Description
Family centered, strength-based, Occupational therapy intervention program
Primary Outcome Measure Information:
Title
Autism: Parenting Questionnaire (APQ) (Kim, Anderson, Birkin, Seymour, & Moore, 2004).
Description
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.
Time Frame
Before intervention (Time 1)
Title
Basic Psychological Need Satisfaction in Relationships (La Guardia, Ryan, Couchman, & Deci 2000).
Description
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.
Time Frame
Before intervention (Time 1)
Title
Canadian Occupational Performance Measure (COPM)- Parent (Law, Baptiste, Carswell, McColl, Polatajko, & Pollock, 1998)
Description
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.
Time Frame
Before intervention (Time 1)
Title
Autism: Parenting Questionnaire (APQ) (Kim, Anderson, Birkin, Seymour, & Moore, 2004).
Description
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.
Time Frame
Immediately post intervention (Time 2)
Title
Basic Psychological Need Satisfaction in Relationships (La Guardia, Ryan, Couchman, & Deci 2000).
Description
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.
Time Frame
Immediately post intervention (Time 2)
Title
Canadian Occupational Performance Measure (COPM)- Parent (Law, Baptiste, Carswell, McColl, Polatajko, & Pollock, 1998)
Description
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.
Time Frame
Immediately post intervention (Time 2)
Title
Autism: Parenting Questionnaire (APQ) (Kim, Anderson, Birkin, Seymour, & Moore, 2004).
Description
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.
Time Frame
Three months post intervention (follow-up-Time 3).
Title
Basic Psychological Need Satisfaction in Relationships (La Guardia, Ryan, Couchman, & Deci 2000).
Description
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.
Time Frame
Three months post intervention (follow-up-Time 3).
Title
Canadian Occupational Performance Measure (COPM)- Parent (Law, Baptiste, Carswell, McColl, Polatajko, & Pollock, 1998)
Description
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.
Time Frame
Three months post intervention (follow-up-Time 3).
Title
Canadian Occupational Performance Measure (COPM)- Parent (Law, Baptiste, Carswell, McColl, Polatajko, & Pollock, 1998)- Transfer goal
Description
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.
Time Frame
Immediately post intervention
Title
Canadian Occupational Performance Measure (COPM)- Parent (Law, Baptiste, Carswell, McColl, Polatajko, & Pollock, 1998)- Transfer goal
Description
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.
Time Frame
Three months post intervention
Secondary Outcome Measure Information:
Title
Canadian Occupational Performance Measure (COPM)-Adolescent (Law, Baptiste, Carswell, McColl, Polatajko, & Pollock, 1998)
Description
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.
Time Frame
Before intervention (Time 1)
Title
Canadian Occupational Performance Measure (COPM)-Adolescent (Law, Baptiste, Carswell, McColl, Polatajko, & Pollock, 1998)
Description
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.
Time Frame
Immediately post intervention (Time 2)
Title
Canadian Occupational Performance Measure (COPM)-Adolescent (Law, Baptiste, Carswell, McColl, Polatajko, & Pollock, 1998)
Description
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.
Time Frame
Three months post intervention (follow-up-Time 3)
Title
Canadian Occupational Performance Measure (COPM)-Adolescent (Law, Baptiste, Carswell, McColl, Polatajko, & Pollock, 1998)- Transfer goal
Description
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.
Time Frame
Immediately post intervention
Title
Canadian Occupational Performance Measure (COPM)-Adolescent (Law, Baptiste, Carswell, McColl, Polatajko, & Pollock, 1998)- Transfer goal
Description
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.
Time Frame
Three months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shlomit Tsafrir, MD
Phone
0503255205
Email
shtsafrir@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tal Mazor-Karsenty, PHD
Phone
0546387621
Email
tal.mazor-karse@mail.huji.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Batel Wachspress, MA
Organizational Affiliation
Hebrew University of Jerusalem
Official's Role
Study Director
Facility Information:
Facility Name
The Hebrew University of Jerusalem
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30188233
Citation
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.
Results Reference
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The Effectiveness of OT-ParentShip on Parental Resilience and Functioning of Adolescents With High Functioning Autism

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