Evaluation of a Resiliency Intervention for Siblings of Children With Autism Spectrum Disorder (ASD)

NCT04369417 | Completed DMC

• 1 other identifier: 2019P003218
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed research has the following objectives: Based off findings from the "Development of a Resiliency Program for Siblings of Children with Autism Spectrum Disorder" qualitative focus group study (protocol 2019P002284), the aim is to determine the feasibility and acceptability, of an 8-session Relaxation Response Resiliency (SibChat) program for siblings of children with ASD. We primarily aim to test the preliminary effectiveness of a pilot waitlist controlled trial on improving resiliency and stress coping, This will be assessed by comparing Baseline-3 mo. scores on primary and secondary outcome measures between the Immediate and Waitlist control groups. Among participants randomized to both conditions, we secondarily aim to investigate the extent of pre-post changes in primary and secondary outcomes. Among immediate condition group only, we also aim to assess whether end-of-treatment (3 mo. post enrollment) improvements will be sustained at 6-mo. post enrollment.

Conditions

Stress

Keywords

Resiliency Training; Autism Spectrum Disorder; Family Relationships

Outcome Measures

Primary Outcomes (7)

• Feasibility assessed by the number participants enrolled.

  We will assess study feasibility based on number of participants enrolled in the study (target N=40)

  6 months

• Feasibility assessed by the number SibChat-3RP of sessions attended

  Whether youth attended at least 5 out of 8 total program sessions.

  8 weeks

• Feasibility assessed by the survey retention post intervention.

  Among participants randomized to both conditions, feasibility is assessed by the number of participants who completed the T2 and T3 surveys, 3 months and 6 months post baseline, respectively.

  6 months

• Acceptability assessed using the participant feedback survey

  The participant feedback survey is a questionnaire made up of likert scales and open ended questions designed to record acceptability of the SibChat-3RP program on topics including length of sessions, number of sessions, and virtual delivery.

  3 months

• Acceptability assessed by relaxation response adherence

  Among participants randomized to both conditions, relaxation response adherence is measured at T1, T2 and T3. Relaxation response adherence is a 1-item likert scale that indicates how often participants practice relaxation response exercises. Acceptability is determined based on whether participants indicate that they practice relaxation response exercises at least bimonthly 3 months post intervention.

  3 months

• Effectiveness of trial on improving stress coping ability (assessed using Measure of Current Status-A)

  Measure of Current Status-A is a questionnaire - the score on the questionnaire is used to indicate stress coping ability. A change in score indicates a change in indicated stress coping ability. Comparison of intervention and wait list control 3 months after baseline (T1).

  3 months

• Effectiveness of trial on improving resiliency (assessed using Current Experiences Scale)

  Current experiences Scale is a questionnaire. Improved resiliency is measured base upon change in questionnaire score. Comparison of intervention and wait list control 3 months after baseline (T1).

  3 months

Secondary Outcomes (2)

• Pre-post intervention changes as measured by change in primary outcome scores of resiliency and stress coping.

  3 months

• Sustained improvements in primary outcomes of resiliency and stress coping as measured by sustained change in primary outcome scores.

  3 months

Study Arms (2)

Experimental: 3RP treatment

EXPERIMENTAL

An adapted version of the Relaxation Response Resiliency Program (3RP) for siblings of children with ASD. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.

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

Active Comparator: Waitlist control

ACTIVE COMPARATOR

An adapted version of the Relaxation Response Resiliency Program (3RP) for siblings of children with ASD. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.

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

Interventions

Relaxation Response Resiliency Program for Siblings of Children with ASD BEHAVIORAL

Virtually delivered psycho-educational resiliency training program for teenage siblings of children with ASD.

Active Comparator: Waitlist control; Experimental: 3RP treatment

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 14-17 years (inclusive of ages 14 and 17)
• Being the sibling of at least one individual with ASD
• Access to internet or smart phone
• English speaking

You may not qualify if:

• Diagnosis of ASD
• Past year psychiatric hospitalization

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Health Resources and Services Administration (HRSA): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Kuhlthau KA, Traeger L, Luberto CM, Perez GK, Goshe BM, Fell L, Iannuzzi D, Park ER. Resiliency Intervention for Siblings of Children With Autism Spectrum Disorder: A Randomized Pilot Trial. Acad Pediatr. 2023 Aug;23(6):1187-1195. doi: 10.1016/j.acap.2022.11.011. Epub 2022 Nov 30.

  PMID: 36460184 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Karen A Kuhlthau, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: April 30, 2020
• Study Start: January 28, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: April 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)