Clinical trial NCT04369417: Evaluation of a Resiliency Intervention for Siblings of Children With Autism Spectrum Disorder (ASD)
Official title: Evaluation of a Resiliency Intervention for Siblings of Children With Autism Spectrum Disorder (ASD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: Resiliency Training
Autism Spectrum Disorder
Family Relationships
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
First posted: 2020-04-30
Enrollment: 44
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility assessed by the number participants enrolled.
timeFrame: 6 months
measure: Feasibility assessed by the number SibChat-3RP of sessions attended
timeFrame: 8 weeks
measure: Feasibility assessed by the survey retention post intervention.
timeFrame: 6 months
measure: Acceptability assessed using the participant feedback survey
timeFrame: 3 months
measure: Acceptability assessed by relaxation response adherence
timeFrame: 3 months
measure: Effectiveness of trial on improving stress coping ability (assessed using Measure of Current Status-A)
timeFrame: 3 months
measure: Effectiveness of trial on improving resiliency (assessed using Current Experiences Scale)
timeFrame: 3 months
Secondary outcomes:
measure: Pre-post intervention changes as measured by change in primary outcome scores of resiliency and stress coping.
timeFrame: 3 months
measure: Sustained improvements in primary outcomes of resiliency and stress coping as measured by sustained change in primary outcome scores.
timeFrame: 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Karen A Kuhlthau, PhD
role: PRINCIPAL_INVESTIGATOR
References: