StressSibChatNCT04369417
Evaluation of a Resiliency Intervention for Siblings of Children With Autism Spectrum Disorder (ASD)
A study testing Relaxation Response Resiliency Program for Siblings of Children with ASD in people with Stress, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Relaxation Response Resiliency Program for Siblings of Children with ASD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2020to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Diagnosis of ASD
- Past year psychiatric hospitalization
- There are no exclusion criteria with respect to ethnicity or socioeconomic status.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02215
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Stress
- Being tested
- Relaxation Response Resiliency Program for Siblings of Children with ASD
- Keywords
- Resiliency Training, Autism Spectrum Disorder, Family Relationships
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation Response Resiliency Program for Siblings of Children with ASDBehavioural
Virtually delivered psycho-educational resiliency training program for teenage siblings of children with ASD.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Relaxation Response Resiliency Program for Siblings of Children with ASD |
| 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. Receives: Behavioral: Relaxation Response Resiliency Program for Siblings of Children with ASD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility assessed by the number participants enrolled.
We will assess study feasibility based on number of participants enrolled in the study (target N=40)
Measured: 6 months
Feasibility assessed by the number SibChat-3RP of sessions attended
Whether youth attended at least 5 out of 8 total program sessions.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Effectiveness of trial on improving stress coping ability (assessed using Measure of Current Status-A)
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).
Measured: 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).
Measured: 3 months
Secondary outcomes (2)
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).
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start28 Jan 2020
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Responsible party
- Principal investigator, Karen Kuhlthau, Massachusetts General Hospital
- Investigators
- Karen A Kuhlthau, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369417
- Sponsor's protocol ID
- 2019P003218
- Acronym
- SibChat
- Status last verified
- Apr 2022
- First submitted
- 20 Feb 2020
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36460184
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Resiliency Intervention for Siblings of Children With Autism Spectrum Disorder (ASD)
- ClinicalTrials.gov ID
- NCT04369417
- Acronym / sponsor ID
- SibChat / 2019P003218
- Conditions
- Stress
- Keywords
- Resiliency Training, Autism Spectrum Disorder, Family Relationships
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 30 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: 3RP treatment | Experimental | Behavioral: Relaxation Response Resiliency Program for Siblings of Children with ASDAn 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 | Behavioral: Relaxation Response Resiliency Program for Siblings of Children with ASDAn 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. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Diagnosis of ASD
- Past year psychiatric hospitalization
- There are no exclusion criteria with respect to ethnicity or socioeconomic status.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relaxation Response Resiliency Program for Siblings of Children with ASDVirtually delivered psycho-educational resiliency training program for teenage siblings of children with ASD. | Behavioural | Active Comparator: Waitlist control, Experimental: 3RP treatment |
Primary outcome
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)
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.
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.
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.
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.
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).
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).
2 secondary outcomes
Pre-post intervention changes as measured by change in primary outcome scores of resiliency and stress coping.
Time frame: 3 months
Sustained improvements in primary outcomes of resiliency and stress coping as measured by sustained change in primary outcome scores.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Derived from this study: PubMed 36460184Kuhlthau 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen A Kuhlthau, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation Response Resiliency Program for Siblings of Children with ASD in people with Stress, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility assessed by the number participants enrolled. (time frame: 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04369417, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.