Adult Caregivers of Individuals With TSCTANDem-2NCT06879665
TANDem-2: Closing the Gap to Interventions for TAND
A study testing Well-Beans for Caregivers Program in people with Adult Caregivers of Individuals With TSC and Tuberous Sclerosis Complex (TSC), run by Vrije Universiteit Brussel at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adult Caregivers of Individuals With TSC, Tuberous Sclerosis Complex (TSC)
- What is being tested?
- Well-Beans for Caregivers Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Jul 2025to 15 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult caregiver of an individual with Tuberous Sclerosis Complex (TSC) of any age
Who cannot join
- Not an adult caregiver of an individual with TSC
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Australia1 site
Tuberous Sclerosis Australia
Beverly Hills, New South Wales, 2209
About this study
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:
- Can this innovative, ultra-brief caregiver well-being intervention be delivered feasibly to caregivers via an online modality?
- How do the caregivers experience the program (acceptability)?
- Does limited efficacy testing suggest the program has an impact on caregiver's well-being?
Read the 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.
- Being tested
- Well-Beans for Caregivers Program
- Keywords
- Caregiver well-being, Psychological flexibility, Acceptance and Commitment Therapy (ACT), Tuberous sclerosis complex (TSC), TSC-Associated Neuropsychiatric Disorders (TAND)
- Medical subject headings
- Tuberous Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Well-Beans for Caregivers ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Well-Beans for Caregivers Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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).
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Change from baseline to immediately post-, and 3 and 6-month post treatment
Change in resilience as measured on the Brief Resilience Scale
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.
Measured: Change from baseline to immediately post-, and 3 and 6-month post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start15 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adult Caregivers of Individuals With TSCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cape Town, United States Department of Defense
- Responsible party
- Principal investigator, Prof Anna Jansen, Vrije Universiteit Brussel
- Investigators
- Anna Jansen, MD, PhD, Principal investigator, Vrije Universiteit BrusselPetrus J de Vries, MD PhD, Principal investigator, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879665
- Sponsor's protocol ID
- EC-2024-222
- Other IDs
- HT94252410790, HT94252410791, 327/2024
- Acronym
- TANDem-2
- Status last verified
- Sep 2025
- First submitted
- 28 Feb 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36352758de Vries PJ, Chambers N, Campbell E, Gutierrez-Lafrentz L, Heunis TM, Schlebusch L, Beaure d'Augeres G, Bissell S, Byars A, Capal J, Cardozo L, Cukier S, Davis P, Epstein NB, Fladrowski C, Flinn J, Gipson T, Goy SL, Kingswood JC, Krueger D, Little F, Lubbe S, Mitchell R, Rozenberg M, Sahin M, Silva M, Smith C, Srivastava S, Takei M, van Eeghen A, Vasseghi M, Wagenaar JP, Waltereit R, De Waele L, Jansen AC. Closing the Gap to Interventions for Tuberous Sclerosis Complex-Associated Neuropsychiatric Disorders (TAND): Protocol for a Longitudinal Study of TAND Severity, Predictors, and Caregiver Well-Being (TANDem-2). JMIR Res Protoc. 2026 May 5;15:e91726. doi: 10.2196/91726.
PubMed 42085697
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TANDem-2: Closing the Gap to Interventions for TAND
- ClinicalTrials.gov ID
- NCT06879665
- Acronym / sponsor ID
- TANDem-2 / EC-2024-222
- Keywords
- Caregiver well-being, Psychological flexibility, Acceptance and Commitment Therapy (ACT), Tuberous sclerosis complex (TSC), TSC-Associated Neuropsychiatric Disorders (TAND)
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Collaborators
- University of Cape Town, United States Department of Defense
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can this innovative, ultra-brief caregiver well-being intervention be delivered feasibly to caregivers via an online modality?
- How do the caregivers experience the program (acceptability)?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Feasibility of "Well-Beans for Caregivers" | Other | Behavioral: Well-Beans for Caregivers ProgramPre-post- quazi-experimental pilot intervention of the feasibility, acceptability and impact of the "Well-Beans for Caregivers" Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult caregiver of an individual with Tuberous Sclerosis Complex (TSC) of any age
Key exclusion criteria (1 listed)
- Not an adult caregiver of an individual with TSC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Well-Beans for Caregivers ProgramThis 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. | Behavioural | Feasibility of "Well-Beans for Caregivers" |
Primary outcome
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.
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.
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.
5 secondary outcomes
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Background: PubMed 36352758Schlebusch 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.
- Derived from this study: PubMed 42085697de Vries PJ, Chambers N, Campbell E, Gutierrez-Lafrentz L, Heunis TM, Schlebusch L, Beaure d'Augeres G, Bissell S, Byars A, Capal J, Cardozo L, Cukier S, Davis P, Epstein NB, Fladrowski C, Flinn J, Gipson T, Goy SL, Kingswood JC, Krueger D, Little F, Lubbe S, Mitchell R, Rozenberg M, Sahin M, Silva M, Smith C, Srivastava S, Takei M, van Eeghen A, Vasseghi M, Wagenaar JP, Waltereit R, De Waele L, Jansen AC. Closing the Gap to Interventions for Tuberous Sclerosis Complex-Associated Neuropsychiatric Disorders (TAND): Protocol for a Longitudinal Study of TAND Severity, Predictors, and Caregiver Well-Being (TANDem-2). JMIR Res Protoc. 2026 May 5;15:e91726. doi: 10.2196/91726.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Jansen, MD, PhD principal investigator
Vrije Universiteit Brussel
Petrus J de Vries, MD PhD principal investigator
University of Cape Town
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Well-Beans for Caregivers Program in people with Adult Caregivers of Individuals With TSC and Tuberous Sclerosis Complex (TSC), run by Vrije Universiteit Brussel at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance rates to assess feasibility (time frame: At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 7 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06879665, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.