TANDem-2: Closing the Gap to Interventions for TAND (TANDem-2)

September 16, 2025 updated by: Prof Anna Jansen, Vrije Universiteit Brussel

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?

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Beverly Hills, New South Wales, Australia, 2209
        • Tuberous Sclerosis Australia
  • United States
    • Maryland
      • Silver Spring, Maryland, United States, 20910
        • TSC Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Feasibility of "Well-Beans for Caregivers"
Pre-post- quazi-experimental pilot intervention of the feasibility, acceptability and impact of the "Well-Beans for Caregivers" Program
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attendance rates to assess feasibility
Time Frame: 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.
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)
Caregivers, facilitators and observers will complete bespoke Feasibility Feedback Forms to assess whether the intervention could be implemented as designed.
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)
Caregivers, facilitators and observers will complete bespoke Acceptability Feedback Forms to assess their experience and acceptability of the program.
At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 7 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 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
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 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
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 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
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 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
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.
Change from baseline to immediately post-, and 3 and 6-month post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vrije Universiteit Brussel

Collaborators

United States Department of Defense
University of Cape Town

Investigators

  • Principal Investigator: Anna Jansen, MD, PhD, Vrije Universiteit Brussel
  • Principal Investigator: Petrus J de Vries, MD PhD, University of Cape Town

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

July 15, 2027

Study Registration Dates

First Submitted

February 28, 2025

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 17, 2025

Study Record Updates

Last Update Posted (Actual)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC-2024-222
  • HT94252410790 (Other Grant/Funding Number: US Department of Defense)
  • HT94252410791 (Other Grant/Funding Number: US Department of Defense)
  • 327/2024 (Other Grant/Funding Number: University of Cape Town Human Research Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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