Clinical trial · Interventional
TANDem-2: Closing the Gap to Interventions for TAND
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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?
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Caregivers of Individuals With TSC | — | UNRESOLVED | — |
| Tuberous Sclerosis Complex (TSC) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Well-Beans for Caregivers Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Feasibility of "Well-Beans for Caregivers"
- description
- Pre-post- quazi-experimental pilot intervention of the feasibility, acceptability and impact of the "Well-Beans for Caregivers" Program
- interventionNames
- Behavioral: Well-Beans for Caregivers Program
Primary outcomes (3)
- measure
- Attendance rates to assess feasibility
- timeFrame
- At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 7 days)
- description
- Attendance rates at each of the three weekly intervention sessions will be tracked as a measure of feasibility of the intervention program.
- measure
- Feasibility Feedback Forms for caregivers, facilitators and observers
- timeFrame
- At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 7 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDSchlebusch 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
- DERIVEDde 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, Jansen AC. Closing the Gap to Interventions for Tuberous Sclerosis Complex-Associated Neuropsychiatric Disorders (TAND): Protocol for a Longitudinal Study of TAND Severity, Predictors, and Caregiver Well-Being (TANDem-2). JMIR Res Protoc. 2026 May 5;15:e91726. doi: 10.2196/91726. PMID 42085697