TANDem-2: Closing the Gap to Interventions for TAND

Обзор

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?

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Attendance rates to assess feasibility [Срок оценки: At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 7 days)]
• Feasibility Feedback Forms for caregivers, facilitators and observers [Срок оценки: At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 7 days)]
• Acceptability Feedback Forms for caregivers, facilitators and observers [Срок оценки: At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 7 days)]

Вторичные конечные точки (5)

• Change in psychological flexibility on the Psy-Flex measure [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Change from baseline to immediately post-, and 3 and 6-month post treatment]
• Change in resilience as measured on the Brief Resilience Scale [Срок оценки: Change from baseline to immediately post-, and 3 and 6-month post treatment]

Критерии участия

Критерии включения

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

Критерии исключения

• Not an adult caregiver of an individual with TSC

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• TSC Alliance — Silver Spring

Австралия · 1 центр

• Tuberous Sclerosis Australia — Beverly Hills

Публикации

• 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
• de 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, J PMID 42085697

Идентификаторы

NCT: NCT06879665 · EC-2024-222 · HT94252410790 · HT94252410791 · 327/2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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