TANDem-2: Closing the Gap to Interventions for TAND
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Well-Beans for Caregivers Program.
- Who it may be relevant to
- Registry conditions: Adult Caregivers of Individuals With TSC, Tuberous Sclerosis Complex (TSC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this pilot study is to determine the feasibility, acceptability and impact of a brief behavioral intervention - the "Well-Beans for Caregivers" program, for adult caregivers of individuals with tuberous sclerosis complex (TSC) of any age. The main questions of the study are: 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?
Detailed description
The investigators hypothesize that an innovative, ultra-brief caregiver wellbeing intervention developed for caregivers of children with developmental disabilities can be adapted as a universal caregiver wellbeing intervention in tuberous sclerosis complex (TSC), that it can be delivered feasibly in an online modality, and will result in changes in key caregiver wellbeing factors. To test these hypotheses, the researchers will adapt the 3-session 'Well-Beans for Caregivers' program through a participatory method with the TAND consortium (the TAND consortium is an international group of clinical and research professionals as well as family members living with individuals with TSC - TAND stands for TSC-Associated Neuropsychiatric Disorders - see tandconsortium.org). The input from the TAND Consortium will be augmented by members of TSCi (Tuberous Sclerosis International), the global network of TSC non-profit organizations.
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.
Interventions
- Behavioral 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.
Primary outcome measures
- Attendance rates to assess feasibility [Time frame: At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 7 days)]
- Feasibility Feedback Forms for caregivers, facilitators and observers [Time frame: At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 7 days)]
- Acceptability Feedback Forms for caregivers, facilitators and observers [Time frame: At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 7 days)]
Secondary outcome measures (5)
- Change in psychological flexibility on the Psy-Flex measure [Time frame: Change from baseline to immediately post-treatment, and at 3 and 6 months post-treatment]
- Change in depression on the Patient Health Questionnaire-9 (PHQ-9) [Time frame: Change from baseline to immediately post-, and 3 and 6-month post treatment]
- Change in anxiety on the Generalized Anxiety Disorder-7 Scale (GAD-7) [Time frame: Change from baseline to immediately post-, and 3 and 6-month post treatment]
- Change in general wellbeing scores on the World Health Organization Wellbeing Index (WHO-5) [Time frame: Change from baseline to immediately post-, and 3 and 6-month post treatment]
- Change in resilience as measured on the Brief Resilience Scale [Time frame: Change from baseline to immediately post-, and 3 and 6-month post treatment]
Eligibility criteria
Inclusion criteria
- Adult caregiver of an individual with Tuberous Sclerosis Complex (TSC) of any age
Exclusion criteria
- Not an adult caregiver of an individual with TSC
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- TSC Alliance — Silver Spring
Australia · 1 center
- Tuberous Sclerosis Australia — Beverly Hills
Publications
- 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. PMID 36352758
- de Vries PJ, Chambers N, Campbell E, Gutierrez-Lafrentz L, Heunis TM, Schlebusch L, Beaure d'Augeres G, Bissell S, Byars A, Capal J, Cardozo L, Cukier S, Davis P, Epstein NB, Fladrowski C, Flinn J, Gipson T, Goy SL, Kingswood JC, Krueger D, Little F, Lubbe S, Mitchell R, Rozenberg M, Sahin M, Silva M, Smith C, Srivastava S, Takei M, van Eeghen A, Vasseghi M, Wagenaar JP, Waltereit R, De Waele L, J PMID 42085697
Identifiers
NCT: NCT06879665 · EC-2024-222 · HT94252410790 · HT94252410791 · 327/2024