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

Primary Purpose

Stress

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Relaxation Response Resiliency Program for Siblings of Children with ASD
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress focused on measuring Resiliency Training, Autism Spectrum Disorder, Family Relationships

Eligibility Criteria

14 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental: 3RP treatment

Active Comparator: Waitlist control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Feasibility assessed by the number participants enrolled.
We 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 attended
Whether youth attended at least 5 out of 8 total program sessions.
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.
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.
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.
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).
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).

Secondary Outcome Measures

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).
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.

Full Information

First Posted
February 20, 2020
Last Updated
April 4, 2022
Sponsor
Massachusetts General Hospital
Collaborators
Health Resources and Services Administration (HRSA)
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1. Study Identification

Unique Protocol Identification Number
NCT04369417
Brief Title
Evaluation of a Resiliency Intervention for Siblings of Children With Autism Spectrum Disorder (ASD)
Acronym
SibChat
Official Title
Evaluation of a Resiliency Intervention for Siblings of Children With Autism Spectrum Disorder (ASD)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 28, 2020 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Health Resources and Services Administration (HRSA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress
Keywords
Resiliency Training, Autism Spectrum Disorder, Family Relationships

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: 3RP treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Active Comparator: Waitlist control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Response Resiliency Program for Siblings of Children with ASD
Intervention Description
Virtually delivered psycho-educational resiliency training program for teenage siblings of children with ASD.
Primary Outcome Measure Information:
Title
Feasibility assessed by the number participants enrolled.
Description
We will assess study feasibility based on number of participants enrolled in the study (target N=40)
Time Frame
6 months
Title
Feasibility assessed by the number SibChat-3RP of sessions attended
Description
Whether youth attended at least 5 out of 8 total program sessions.
Time Frame
8 weeks
Title
Feasibility assessed by the survey retention post intervention.
Description
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.
Time Frame
6 months
Title
Acceptability assessed using the participant feedback survey
Description
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.
Time Frame
3 months
Title
Acceptability assessed by relaxation response adherence
Description
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.
Time Frame
3 months
Title
Effectiveness of trial on improving stress coping ability (assessed using Measure of Current Status-A)
Description
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).
Time Frame
3 months
Title
Effectiveness of trial on improving resiliency (assessed using Current Experiences Scale)
Description
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).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Pre-post intervention changes as measured by change in primary outcome scores of resiliency and stress coping.
Description
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).
Time Frame
3 months
Title
Sustained improvements in primary outcomes of resiliency and stress coping as measured by sustained change in primary outcome scores.
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen A Kuhlthau, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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