TANDem-2: Closing the Gap to Interventions for TAND
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Attendance rates to assess feasibility
研究概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult caregiver of an individual with Tuberous Sclerosis Complex (TSC) of any age
排除标准
- •Not an adult caregiver of an individual with TSC
结局指标
主要结局
Attendance rates to assess feasibility
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
- 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)
研究者
Prof Anna Jansen
Professor
Vrije Universiteit Brussel