Clinical trial NCT06879665: TANDem-2: Closing the Gap to Interventions for TAND
Official title: TANDem-2: Closing the Gap to Interventions for TAND
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Adult Caregivers of Individuals with TSC
Tuberous Sclerosis Complex (TSC)
Keywords: Caregiver well-being
Psychological flexibility
Acceptance and Commitment Therapy (ACT)
Tuberous sclerosis complex (TSC)
TSC-Associated Neuropsychiatric Disorders (TAND)
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
Collaborators: name: University of Cape Town
name: United States Department of Defense
First posted: 2025-03-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Attendance rates to assess feasibility
timeFrame: At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 7 days)
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)
measure: Acceptability Feedback Forms for caregivers, facilitators and observers
timeFrame: At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 7 days)
Secondary outcomes:
measure: Change in psychological flexibility on the Psy-Flex measure
timeFrame: Change from baseline to immediately post-treatment, and at 3 and 6 months post-treatment
measure: Change in depression on the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Change from baseline to immediately post-, and 3 and 6-month post treatment
measure: Change in anxiety on the Generalized Anxiety Disorder-7 Scale (GAD-7)
timeFrame: Change from baseline to immediately post-, and 3 and 6-month post treatment
measure: Change in general wellbeing scores on the World Health Organization Wellbeing Index (WHO-5)
timeFrame: Change from baseline to immediately post-, and 3 and 6-month post treatment
measure: Change in resilience as measured on the Brief Resilience Scale
timeFrame: Change from baseline to immediately post-, and 3 and 6-month post treatment
Other outcomes:
Locations:
Study officials:
affiliation: Vrije Universiteit Brussel
name: Anna Jansen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cape Town
name: Petrus J de Vries, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.