Evaluation of a Resiliency Intervention for Siblings of Children With Autism Spectrum Disorder (ASD) (SibChat)
4. april 2022 opdateret af: Karen Kuhlthau, Massachusetts General Hospital
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
44
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- Massachusetts General Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
14 år til 17 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Virtually delivered psycho-educational resiliency training program for teenage siblings of children with ASD.
|
|
Aktiv komparator: 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.
|
Virtually delivered psycho-educational resiliency training program for teenage siblings of children with ASD.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility assessed by the number participants enrolled.
Tidsramme: 6 months
|
We will assess study feasibility based on number of participants enrolled in the study (target N=40)
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6 months
|
|
Feasibility assessed by the number SibChat-3RP of sessions attended
Tidsramme: 8 weeks
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Whether youth attended at least 5 out of 8 total program sessions.
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8 weeks
|
|
Feasibility assessed by the survey retention post intervention.
Tidsramme: 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.
|
6 months
|
|
Acceptability assessed using the participant feedback survey
Tidsramme: 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.
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3 months
|
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Acceptability assessed by relaxation response adherence
Tidsramme: 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.
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3 months
|
|
Effectiveness of trial on improving stress coping ability (assessed using Measure of Current Status-A)
Tidsramme: 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).
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3 months
|
|
Effectiveness of trial on improving resiliency (assessed using Current Experiences Scale)
Tidsramme: 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).
|
3 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pre-post intervention changes as measured by change in primary outcome scores of resiliency and stress coping.
Tidsramme: 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).
|
3 months
|
|
Sustained improvements in primary outcomes of resiliency and stress coping as measured by sustained change in primary outcome scores.
Tidsramme: 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.
|
3 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Karen A Kuhlthau, PhD, Massachusetts General Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
28. januar 2020
Primær færdiggørelse (Faktiske)
1. januar 2021
Studieafslutning (Faktiske)
1. januar 2021
Datoer for studieregistrering
Først indsendt
20. februar 2020
Først indsendt, der opfyldte QC-kriterier
27. april 2020
Først opslået (Faktiske)
30. april 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. april 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. april 2022
Sidst verificeret
1. april 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2019P003218
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