Development of a Resiliency Training Program for Parents of Children With Autism Spectrum Disorder

NCT02995408 | Completed Results DMC

• 1 other identifier: 2016P002037
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This study has three aims: Phase I: Through focus group interviews with expert clinicians, leaders of organizations, and parents with children with ASD, this study aims to identify the psychosocial needs of parents of children with ASD, specifically a) the types of concerns that parents find most difficult and stressful b) areas of concern that lack support and resources, and c) areas of need for education and skill training. This study also aims to gather feedback on the Benson-Henry Institute's Relaxation Response Resiliency Program (3RP). Phase II: Informed by Phase I findings, this study aims to develop and determine the feasibility and acceptability of a virtual 8-session Relaxation Response Resiliency (3RP) program for parents of children with ASD. Phase II: This study also aims to test the effectiveness of a pilot wait-list control trial, establishing efficacy of a virtual resiliency program.

Conditions

Stress

Keywords

resiliency training; parenting; Autism Spectrum Disorders

Outcome Measures

Primary Outcomes (3)

• Distress

  Visual Analogue Scale-Distress is a 1-item scale which asks responders to rate their level of distress on a scale of 0 to 10. A higher score indicates more distress.

  change between baseline (week 0) to post intervention (week 12)

• Resiliency

  Current Experiences Scale is a 25-item measure of resilience adapted from the Post-Traumatic Growth Inventory to reflect current functioning in the domains of appreciation for life, adaptive perspectives, personal strength, spiritual connectedness, relating to others, and an additional four items to assess current adaptive health behaviors. Total scores range from 0-25 and higher scores indicate greater resilience.

  change between baseline (week 0) to post intervention (week 12)

• Stress Reactivity/Coping

  Measure of Current Status (MOCS-A) is a 13-item self-report measure developed to assess perceived status on ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses. Total score range is 0 to 52, and higher scores indicate greater perceived proficiency with these skills.

  change between baseline (week 0) to post-intervention (week 12)

Study Arms (2)

Experimental: 3RP treatment

EXPERIMENTAL

An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with ASD. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies. Experimental arm participated in the 8-week 3RP program starting immediately after enrollment.

Behavioral: Relaxation Response Resiliency Program for Parents of Children with ASD

Waitlist control

ACTIVE COMPARATOR

An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with ASD. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies. The waitlist arm participated in the 8-week 3RP program starting 3 months after enrollment.

Behavioral: Relaxation Response Resiliency Program for Parents of Children with ASD

Interventions

Relaxation Response Resiliency Program for Parents of Children with ASD BEHAVIORAL

Experimental: 3RP treatment; Waitlist control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being the parent of at least one child with a diagnosed autism spectrum disorder
• Age 18 or older

You may not qualify if:

• \. Unable or unwilling to sign the informed consent documents

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Kuhlthau KA, Luberto CM, Traeger L, Millstein RA, Perez GK, Lindly OJ, Chad-Friedman E, Proszynski J, Park ER. A Virtual Resiliency Intervention for Parents of Children with Autism: A Randomized Pilot Trial. J Autism Dev Disord. 2020 Jul;50(7):2513-2526. doi: 10.1007/s10803-019-03976-4.

  PMID: 30900195 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Karen Kuhlthau, PhD Researcher
• Organization: Massachusetts General Hospital

kkuhlthau@partners.org

6177242842

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 16, 2016
• Study Start: December 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: March 12, 2024
• Results First Posted: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)