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

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Clalit Health Services

Status

Enrolling

Conditions

Autism Spectrum Disorder

Treatments

Other: Parent intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05879705
0119-20-COM

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

30 to 80 years old

Volunteers

Accepts 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

An OT-ParentShip intervention
Experimental group
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.
Treatment:
Other: Parent intervention
A psycho-educational intervention group.
Other group
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.
Treatment:
Other: Parent intervention

Trial contacts and locations

1

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Central trial contact

Tal Mazor-Karsenty, PHD; Shlomit Tsafrir, MD

Data sourced from clinicaltrials.gov

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