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

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.

Study Overview

• Status: Completed
• Conditions: Stress
• Intervention / Treatment: Behavioral: Relaxation Response Resiliency Program for Siblings of Children with ASD

Detailed Description

This intervention will be a modified version of Dr. Elyse Park's evidence-based 8-week multimodal treatment which is designed to promote adaptation to stress and promotion of resiliency. The program is an 8 session, 1 hour a week multi modal intervention that incorporates relaxation techniques, stress awareness discussion, and adaptive strategies for coping with stress. This study will refine an 8-session group virtual-delivered resiliency treatment program consisting of 8 virtual group 1-1 ½ hour sessions. The goal of this study would be to advance our ultimate objective to implement a national sibling resiliency program.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Diagnosis of ASD
2. Past year psychiatric hospitalization

There are no exclusion criteria with respect to ethnicity or socioeconomic status.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: 3RP treatment; 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; Virtually delivered psycho-educational resiliency training program for teenage siblings of children with ASD.
Active Comparator: Active Comparator: Waitlist control; 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; Virtually delivered psycho-educational resiliency training program for teenage siblings of children with ASD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-post intervention changes as measured by change in primary outcome scores of resiliency and stress coping.	Among participants randomized to both conditions, pre-post intervention changes in primary outcome scores of resiliency and stress coping will be assessed using the scores from the questionnaire (includes all primary outcome scores indicated above).	3 months
Sustained improvements in primary outcomes of resiliency and stress coping as measured by sustained change in primary outcome scores.	Among immediate condition group only, assess whether end-of-treatment (3 mo. post enrollment) improvements in primary outcome scores (resiliency and stress coping indicated above; collected using a questionnaire) will be sustained at 6-mo. post enrollment.	3 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Health Resources and Services Administration (HRSA)
• Investigators: Principal Investigator: Karen A Kuhlthau, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2020
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: February 20, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Autism Spectrum Disorder; Resiliency Training; Family Relationships
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: 2019P003218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No