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| Name | Class |
|---|---|
| Health Resources and Services Administration (HRSA) | FED |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: 3RP treatment | Experimental | 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. |
|
| Active Comparator: Waitlist control | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility assessed by the number participants enrolled. | We will assess study feasibility based on number of participants enrolled in the study (target N=40) | 6 months |
| Feasibility assessed by the number SibChat-3RP of sessions attended | Whether youth attended at least 5 out of 8 total program sessions. | 8 weeks |
| 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. | 6 months |
| 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. | 3 months |
| 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. | 3 months |
| Effectiveness of trial on improving stress coping ability (assessed using Measure of Current Status-A) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
There are no exclusion criteria with respect to ethnicity or socioeconomic status.
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| Name | Affiliation | Role |
|---|---|---|
| Karen A Kuhlthau, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36460184 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 26, 2024 | |
| Reset | Sep 19, 2024 | |
| Release | Jan 15, 2026 | |
| Reset | Jan 30, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 26, 2024 | Sep 19, 2024 | |||
| Jan 15, 2026 |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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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).
| 3 months |
| 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). | 3 months |
| 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. | 3 months |
| Jan 30, 2026 |