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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04369417
Acronym
SibChat
Enrollment
44
Registered
2020-04-30
Start date
2020-01-28
Completion date
2021-01-01
Last updated
2022-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress

Keywords

Resiliency Training, Autism Spectrum Disorder, Family Relationships

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.

Interventions

BEHAVIORALRelaxation Response Resiliency Program for Siblings of Children with ASD

Virtually delivered psycho-educational resiliency training program for teenage siblings of children with ASD.

Sponsors

Health Resources and Services Administration (HRSA)
CollaboratorFED
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 17 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Effectiveness of trial on improving resiliency (assessed using Current Experiences Scale)3 monthsCurrent 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).
Acceptability assessed by relaxation response adherence3 monthsAmong 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.
Effectiveness of trial on improving stress coping ability (assessed using Measure of Current Status-A)3 monthsMeasure 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 participants enrolled.6 monthsWe will assess study feasibility based on number of participants enrolled in the study (target N=40)
Feasibility assessed by the number SibChat-3RP of sessions attended8 weeksWhether youth attended at least 5 out of 8 total program sessions.
Feasibility assessed by the survey retention post intervention.6 monthsAmong 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 using the participant feedback survey3 monthsThe 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.

Secondary

MeasureTime frameDescription
Sustained improvements in primary outcomes of resiliency and stress coping as measured by sustained change in primary outcome scores.3 monthsAmong 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 monthsAmong 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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026