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

NCT ID: NCT05879705

Last Updated: 2023-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-03

Study Completion Date

2023-09-30

Brief Summary

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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

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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.

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A mixed method, two group, randomized controlled trial (RCT).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Parent intervention

Intervention Type OTHER

Family centered, strength-based, Occupational therapy intervention program

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.

Group Type OTHER

Parent intervention

Intervention Type OTHER

Family centered, strength-based, Occupational therapy intervention program

Interventions

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Parent intervention

Family centered, strength-based, Occupational therapy intervention program

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hebrew University of Jerusalem

OTHER

Sponsor Role collaborator

Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Batel Wachspress, MA

Role: STUDY_DIRECTOR

Hebrew University of Jerusalem

Locations

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The Hebrew University of Jerusalem

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Shlomit Tsafrir, MD

Role: CONTACT

0503255205

Tal Mazor-Karsenty, PHD

Role: CONTACT

0546387621

References

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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.

Reference Type BACKGROUND
PMID: 30188233 (View on PubMed)

Other Identifiers

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0119-20-COM

Identifier Type: -

Identifier Source: org_study_id

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