Evaluation of a Resiliency Intervention for Siblings of Children With Autism Spectrum Disorder (ASD)
- Conditions
- Stress
- Interventions
- Behavioral: Relaxation Response Resiliency Program for Siblings of Children with ASD
- Registration Number
- NCT04369417
- Lead Sponsor
- Massachusetts General Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- 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
- Diagnosis of ASD
- Past year psychiatric hospitalization
There are no exclusion criteria with respect to ethnicity or socioeconomic status.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Experimental: 3RP treatment Relaxation Response Resiliency Program for Siblings of Children with ASD 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. Active Comparator: Waitlist control Relaxation Response Resiliency Program for Siblings of Children with ASD 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.
- Primary Outcome Measures
Name Time Method Effectiveness of trial on improving stress coping ability (assessed using Measure of Current Status-A) 3 months 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).
Feasibility assessed by the number SibChat-3RP of sessions attended 8 weeks Whether youth attended at least 5 out of 8 total program sessions.
Acceptability assessed using the participant feedback survey 3 months 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.
Feasibility assessed by the number participants enrolled. 6 months We will assess study feasibility based on number of participants enrolled in the study (target N=40)
Effectiveness of trial on improving resiliency (assessed using Current Experiences Scale) 3 months 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).
Feasibility assessed by the survey retention post intervention. 6 months 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.
Acceptability assessed by relaxation response adherence 3 months 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.
- Secondary Outcome Measures
Name Time Method Sustained improvements in primary outcomes of resiliency and stress coping as measured by sustained change in primary outcome scores. 3 months 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.
Pre-post intervention changes as measured by change in primary outcome scores of resiliency and stress coping. 3 months 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).
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States