Ignite Creation Date:
2024-05-06 @ 2:35 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04369417
Status:
COMPLETED
Last Update Posted:
2022-04-05
First Post:
2020-02-20
Brief Title:
Evaluation of a Resiliency Intervention for Siblings of Children With Autism Spectrum Disorder ASD
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Evaluation of a Resiliency Intervention for Siblings of Children With Autism Spectrum Disorder ASD
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SibChat
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
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 Parks 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None