Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-01-09 @ 7:23 PM
Study NCT ID:
NCT05879705
Status:
UNKNOWN
Last Update Posted:
2023-05-30
First Post:
2023-03-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of OT-ParentShip on Parental Resilience and Functioning of Adolescents With High Functioning Autism
Sponsor:
Meir Medical Center
Organization:
Study Overview
Official Title:
The Effectiveness of OT-ParentShip on Parental Resilience and Functioning of Adolescents With High Functioning Autism
Status:
UNKNOWN
Status Verified Date:
2023-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: