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

NCT ID: NCT04369417

Last Updated: 2022-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-28

Study Completion Date

2021-01-01

Brief Summary

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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

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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.

Conditions

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Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Relaxation Response Resiliency Program for Siblings of Children with ASD

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Relaxation Response Resiliency Program for Siblings of Children with ASD

Intervention Type BEHAVIORAL

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

Interventions

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Relaxation Response Resiliency Program for Siblings of Children with ASD

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Health Resources and Services Administration (HRSA)

FED

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Karen Kuhlthau

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen A Kuhlthau, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Kuhlthau KA, Traeger L, Luberto CM, Perez GK, Goshe BM, Fell L, Iannuzzi D, Park ER. Resiliency Intervention for Siblings of Children With Autism Spectrum Disorder: A Randomized Pilot Trial. Acad Pediatr. 2023 Aug;23(6):1187-1195. doi: 10.1016/j.acap.2022.11.011. Epub 2022 Nov 30.

Reference Type DERIVED
PMID: 36460184 (View on PubMed)

Other Identifiers

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2019P003218

Identifier Type: -

Identifier Source: org_study_id

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