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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05879705
• Other study ID #: 0119-20-COM
• Status: Recruiting
• Phase: N/A
• Start date: March 3, 2021
• Est. completion date: September 2023

Study information

• Verified date: May 2023
• Source: Meir Medical Center
• Contact: Shlomit Tsafrir, MD
• Phone: 0503255205
• Email: shtsafrir[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Other:
• Parent intervention
Family centered, strength-based, Occupational therapy intervention program

Locations

Country	Name	City	State
Israel	The Hebrew University of Jerusalem	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Meir Medical Center	Hebrew University of Jerusalem

Country where clinical trial is conducted

Israel, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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).
Primary	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).
Primary	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).
Primary	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
Primary	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	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.	Before intervention (Time 1)
Secondary	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.	Immediately post intervention (Time 2)
Secondary	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.	Three months post intervention (follow-up-Time 3)
Secondary	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.	Immediately post intervention
Secondary	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.	Three months post intervention