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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stress

Intervention / Treatment
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* Behavioral: Relaxation Response Resiliency Program for Siblings of Children with ASD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Diagnosis of ASD Past year psychiatric hospitalization There are no exclusion criteria with respect to ethnicity or socioeconomic status.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resiliency Training, Autism Spectrum Disorder, Family Relationships