TANDem-2: Closing the Gap to Interventions for TAND

Not Applicable

Not yet recruiting

• Conditions: Adult Caregivers of Individuals with TSC; Tuberous Sclerosis Complex (TSC)

• Registration Number: NCT06879665
• Lead Sponsor: Vrije Universiteit Brussel

Brief Summary

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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-28
• Study First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-13
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17
• Study Start: 2025-07-15
• Primary Completion: 2026-12-31
• Study Completion: 2027-07-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Attendance rates to assess feasibility	At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 7 days)	Attendance rates at each of the three weekly intervention sessions will be tracked as a measure of feasibility of the intervention program.
Feasibility Feedback Forms for caregivers, facilitators and observers	At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 7 days)	Caregivers, facilitators and observers will complete bespoke Feasibility Feedback Forms to assess whether the intervention could be implemented as designed.
Acceptability Feedback Forms for caregivers, facilitators and observers	At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 7 days)	Caregivers, facilitators and observers will complete bespoke Acceptability Feedback Forms to assess their experience and acceptability of the program.

Secondary Outcome Measures

Name	Time	Method
Change in psychological flexibility on the Psy-Flex measure	Change from baseline to immediately post-treatment, and at 3 and 6 months post-treatment	Changes in scores on the Psy-Flex (Gloster, 2021) will be used to assess changes in caregiver psychological flexibility from before to after treatment. The Psy-Flex consists of 6 items with a minimum score of 6 and a maximum score of 30. Higher scores indicate better psychological flexibility (better outcome).
Change in depression on the Patient Health Questionnaire-9 (PHQ-9)	Change from baseline to immediately post-, and 3 and 6-month post treatment	Changes in participant levels of depression will be measured via changes in scores on the Patient Health Questionnaire (PHQ-9) from before to after the intervention and at two follow-up intervals. The PHQ consists of 9 items with a minimum score of 0 and a maximum score of 27. Higher scores indicate higher levels of depression.
Change in anxiety on the Generalized Anxiety Disorder-7 Scale (GAD-7)	Change from baseline to immediately post-, and 3 and 6-month post treatment	Changes in anxiety will be assessed via changes in scores on the Generalized Anxiety Disorder-7 Scale (GAD-7). This is a 7-item scale with a minimum score of 0 and a maximum score of 21. Higher scores indicate higher levels of anxiety.
Change in general wellbeing scores on the World Health Organization Wellbeing Index (WHO-5)	Change from baseline to immediately post-, and 3 and 6-month post treatment	Changes in general wellbeing will be assessed via changes in scores on the WHO-5 Wellbeing Index (WHO-5). This is a 5-item scale with a minimum score of 0 and a maximum score of 25. Higher scores indicate higher levels of well-being.
Change in resilience as measured on the Brief Resilience Scale	Change from baseline to immediately post-, and 3 and 6-month post treatment	Changes in resilience will be assessed via changes in scores on the Brief Resilience Scale (BRS). The BRS is a 6-item scale with a minimum score of 6 and a maximum score of 30. Higher scores indicate higher levels of resilience. Citation: Smith, B. W., Dalen, J., Wiggins, K., Tooley, E., Christopher, P., \& Bernard, J. (2008). The brief resilience scale: assessing the ability to bounce back. International journal of behavioral medicine, 15(3), 194-200.