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Completed

NCT Number: NCT04369417

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

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.

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Key information

Conditions

Stress Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

14 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Relaxation Response Resiliency Program for Siblings of Children with ASD

Behavioral

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

Primary outcomes

  1. Feasibility assessed by the number participants enrolled.

    Time frame: 6 months

    We will assess study feasibility based on number of participants enrolled in the study (target N=40)

  2. Feasibility assessed by the number SibChat-3RP of sessions attended

    Time frame: 8 weeks

    Whether youth attended at least 5 out of 8 total program sessions.

  3. Feasibility assessed by the survey retention post intervention.

    Time frame: 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.

  4. Acceptability assessed using the participant feedback survey

    Time frame: 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.

  5. Acceptability assessed by relaxation response adherence

    Time frame: 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.

  6. Effectiveness of trial on improving stress coping ability (assessed using Measure of Current Status-A)

    Time frame: 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).

  7. Effectiveness of trial on improving resiliency (assessed using Current Experiences Scale)

    Time frame: 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).

Secondary outcomes

  1. Pre-post intervention changes as measured by change in primary outcome scores of resiliency and stress coping.

    Time frame: 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).

  2. Sustained improvements in primary outcomes of resiliency and stress coping as measured by sustained change in primary outcome scores.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Health Resources and Services Administration (HRSA)

Registry information

Acronym: SibChat

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 30, 2020
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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