Study Results
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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ENROLLING_BY_INVITATION
NA
30 participants
INTERVENTIONAL
2025-07-15
2027-07-15
Brief Summary
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1. Can this innovative, ultra-brief caregiver well-being intervention be delivered feasibly to caregivers via an online modality?
2. How do the caregivers experience the program (acceptability)?
3. Does limited efficacy testing suggest the program has an impact on caregiver's well-being?
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Detailed Description
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For step 2 (pilot intervention), two specialist facilitators and four trainee observers will deliver the 3-session program using ZoomPro, a secure online platform to two groups of 10-12 caregivers. Caregivers are those who provide long-term, day-to-day support and care, and this group includes parents, partners, relatives, or other family members (not paid professional caregivers). These sessions will not be recorded to ensure that participants can join the program without feeling concerned about being recorded. Data collection will use a quasi-experimental pre-post-test design. Eligible and consented participants will therefore complete baseline data as 'pre-test' and then 'post-test' data after the 3-week intervention. Following this, they will complete 3-month and 6-month data collection. Caregiver wellbeing measures will only include open access and freely available measures. The program as well as data collection will be conducted in English.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Feasibility of "Well-Beans for Caregivers"
Pre-post- quazi-experimental pilot intervention of the feasibility, acceptability and impact of the "Well-Beans for Caregivers" Program
Well-Beans for Caregivers Program
This is a brief behavioral intervention consisting of 3 weekly 2-hour sessions. The sessions are based on Acceptance and Commitment Therapy (ACT) and are designed to improve psychological flexibility in caregivers. This in turn is designed to help them connect with their difficult emotions and experiences in a flexible way, and improve emotional well-being.
Interventions
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Well-Beans for Caregivers Program
This is a brief behavioral intervention consisting of 3 weekly 2-hour sessions. The sessions are based on Acceptance and Commitment Therapy (ACT) and are designed to improve psychological flexibility in caregivers. This in turn is designed to help them connect with their difficult emotions and experiences in a flexible way, and improve emotional well-being.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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University of Cape Town
OTHER
United States Department of Defense
FED
Vrije Universiteit Brussel
OTHER
Responsible Party
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Prof Anna Jansen
Professor
Principal Investigators
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Anna Jansen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Vrije Universiteit Brussel
Petrus J de Vries, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Cape Town
Locations
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TSC Alliance
Silver Spring, Maryland, United States
Tuberous Sclerosis Australia
Beverly Hills, New South Wales, Australia
Countries
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References
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Schlebusch L, Chambers N, Rosenstein D, Erasmus P; WHO CST Team; de Vries PJ. Supporting caregivers of children with developmental disabilities: Findings from a brief caregiver well-being programme in South Africa. Autism. 2024 Jan;28(1):199-214. doi: 10.1177/13623613221133182. Epub 2022 Nov 9.
Other Identifiers
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HT94252410790
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
HT94252410791
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
327/2024
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
EC-2024-222
Identifier Type: -
Identifier Source: org_study_id
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