TANDem-2: Closing the Gap to Interventions for TAND

Vrije Universiteit Brussel

Status: Invitation-only

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

Treatments: Behavioral: Well-Beans for Caregivers Program

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06879665

HT94252410790 (Other Grant/Funding Number)

EC-2024-222

327/2024 (Other Grant/Funding Number)

HT94252410791 (Other Grant/Funding Number)

Details and patient eligibility

About

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?

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Feasibility of "Well-Beans for Caregivers"

Other group

Description:

Pre-post- quazi-experimental pilot intervention of the feasibility, acceptability and impact of the "Well-Beans for Caregivers" Program

Treatment:

Behavioral: Well-Beans for Caregivers Program