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

Stress Clinical Trial

— SibChat  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04369417
• Other study ID #: 2019P003218
• Status: Completed
• Phase: N/A
• Start date: January 28, 2020
• Est. completion date: January 1, 2021

Study information

• Verified date: April 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Stress

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Health Resources and Services Administration (HRSA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Feasibility assessed by the number SibChat-3RP of sessions attended	Whether youth attended at least 5 out of 8 total program sessions.	8 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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