TANDem-2: Closing the Gap to Interventions for TAND

NCT06879665 | Enrolling By Invitation

• 4 other identifiers: EC-2024-222HT94252410790HT94252410791327/2024
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 2

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. 1.Can this innovative, ultra-brief caregiver well-being intervention be delivered feasibly to caregivers via an online modality?
2. 2.How do the caregivers experience the program (acceptability)?
3. 3.Does limited efficacy testing suggest the program has an impact on caregiver's well-being?

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)

Outcome Measures

Primary Outcomes (3)

• Attendance rates to assess feasibility

  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

  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

  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 Outcomes (5)

• Change in psychological flexibility on the Psy-Flex measure

  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)

  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)

  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)

  Change from baseline to immediately post-, and 3 and 6-month post treatment

• Change in resilience as measured on the Brief Resilience Scale

  Change from baseline to immediately post-, and 3 and 6-month post treatment

Study Arms (1)

Feasibility of "Well-Beans for Caregivers"

OTHER

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

Interventions

Well-Beans for Caregivers Program BEHAVIORAL

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.

Feasibility of "Well-Beans for Caregivers"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult caregiver of an individual with Tuberous Sclerosis Complex (TSC) of any age

You may not qualify if:

• Not an adult caregiver of an individual with TSC

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• University of Cape Town: collaborator
• United States Department of Defense: collaborator

Study Sites (2)

TSC Alliance

Silver Spring, Maryland, 20910, United States

Location

Tuberous Sclerosis Australia

Beverly Hills, New South Wales, 2209, Australia

Location

Related Publications (1)

• 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.

  PMID: 36352758 BACKGROUND

MeSH Terms

Conditions

Tuberous Sclerosis

Condition Hierarchy (Ancestors)

Hamartoma; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Nervous System Diseases; Neurocutaneous Syndromes; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Anna Jansen, MD, PhD

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

• Petrus J de Vries, MD PhD

  University of Cape Town

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 17, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 15, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); US (1)