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

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ClinicalTrials.gov Identifier: NCT04369417
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : July 29, 2020
Sponsor:
Collaborator:
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
Karen Kuhlthau, Massachusetts General Hospital

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.


Condition or disease Intervention/treatment Phase
Stress Behavioral: Relaxation Response Resiliency Program for Siblings of Children with ASD Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Resiliency Intervention for Siblings of Children With Autism Spectrum Disorder (ASD)
Actual Study Start Date : January 28, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental: 3RP treatment
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
Virtually delivered psycho-educational resiliency training program for teenage siblings of children with ASD.

Active Comparator: Active Comparator: Waitlist control
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
Virtually delivered psycho-educational resiliency training program for teenage siblings of children with ASD.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369417


Contacts
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Contact: Karen A Kuhlthau, PhD 617-724-2842 kkuhlthau@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Karen A Kuhlthau, PhD    617-724-2842    kkuhlthau@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Health Resources and Services Administration (HRSA)
Investigators
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Principal Investigator: Karen A Kuhlthau, PhD Massachusetts General Hospital
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Responsible Party: Karen Kuhlthau, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04369417    
Other Study ID Numbers: 2019P003218
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karen Kuhlthau, Massachusetts General Hospital:
Resiliency Training
Autism Spectrum Disorder
Family Relationships
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders