Brief Self-Compassion Intervention for Adolescents With Diabetes Type 1 and Their Caregivers: Protocol for a Single Case Multiple-baseline Feasibility Study
试验速览
- 阶段
- 不适用
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Change in Self-report psychological variables: self-compassion (teens)
研究概览
简要总结
The goal of this study is to examine the feasibility and potential effectiveness of a short (4 sessions) self-compassion intervention for adolescents with T1D and their caregivers on psychological, metabolic, and behavioral outcomes.
详细描述
Type 1 Diabetes (TD1) has a significant impact on individuals dealing with this chronic metabolic condition, their families and the whole society. A particularly vulnerable group of individuals with TD1 are adolescents. The investigators created a short (4 sessions) self-compassion intervention for adolescents with T1D and their caregivers. Both feasibility and potential clinical effectiveness will be assessed using a single-case, multiple baseline experimental design where psychological, behavioral, and metabolic outcomes will be evaluated at baseline, post intervention, and 3- and 6-months follow ups. Moreover, ecological momentary assessment will be performed daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
No blinding can be used however the researcher will be blinded when coding observational data.
入排标准
- 年龄范围
- 12 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •non-Spanish native speakers
- •presenting developmental or attention deficit disorders (e.g., autism spectrum disorder, ADHD)
- •being diagnosed with a serious mental disorder requiring ongoing treatment (e.g., psychosis) or receiving a pharmacological intervention (e.g., depression, anxiety).
- •Exclusion criteria for teens:
- •untreated hypothyroidism
- •recently (in previous 48 hours of the recruiting process) diagnosed with (a) diabetic ketoacidosis (DKA) or (b) severe hypoglycaemia.
结局指标
主要结局
Change in Self-report psychological variables: self-compassion (teens)
时间窗: Change in SOCS-S from pre (Day 1) to post (Day 30). Change in SOCS-S from post (Day 30) to follow up3 (Month 3). Change in SOCS-S from follow up 3 (month 3) to follow up 6 (month 6).
- 20 items for teens: SOCS-S (Gu et al., 2020); Spanish version back forward translation and adapted to teens
Change in Self-report psychological variables: self care (teens)
时间窗: Change in B-MSC from pre (Day 1) to post (Day 30). Change in B-MSC from post (Day 30) to follow up3 (Month 3). Change in B-MSC from follow up 3 (month 3) to follow up 6 (month 6).
- 24 items for teens: B-MSC (Cook-Cottone, 2018); Spanish version back forward translation and adapted to teens
Change in Self-report psychological variables: depression ( teens)
时间窗: change in PHQ from pre (Day 1) to post (Day 30). Change in PHQ from post (Day30) to Follow up3 (Month 3). Change in PHQ from Follow up 3 (month 3) to Follow up6 (Month 6)
- 2 items for teens: PHQ-2 (Richardson et al., 2010; Spanish version: Arrieta et al., 2017)
Change in Self-report psychological variables: interoceptive awareness (caregivers)
时间窗: Change in MAIA-2 from pre (Day 1) to post (Day 30). Change in MAIA-2 from post (Day 30) to follow up3 (Month 3). Change in MAIA-2 from follow up 3 (month 3) to follow up 6 (month 6).
- 32 items for caregivers: MAIA-2 (Mehling et al., 2018); Spanish version back forward translation
Change in Self-report psychological variables: depression (caregivers )
时间窗: change in PHQ from pre (Day 1) to post (Day 30). Change in PHQ from post (Day30) to Follow up3 (Month 3). Change in PHQ from Follow up 3 (month 3) to Follow up6 (Month 6)
- 2 items for caregivers: PHQ-2 (Kroenke, 2003; Spanish version: Wulsin et al., 2002)
Change in Self-report psychological variables: self-compassion (caregivers)
时间窗: Change in SOCS-S from pre (Day 1) to post (Day 30). Change in SOCS-S from post (Day 30) to follow up3 (Month 3). Change in SOCS-S from follow up 3 (month 3) to follow up 6 (month 6).
- 20 items for caregivers: SOCS-S (Gu et al., 2020); Spanish version back forward translation
Change in Self-report psychological variables: self care (caregivers)
时间窗: Change in B-MSC from pre (Day 1) to post (Day 30). Change in B-MSC from post (Day 30) to follow up3 (Month 3). Change in B-MSC from follow up 3 (month 3) to follow up 6 (month 6).
- 24 items for caregivers: B-MSC (Cook-Cottone, 2018); Spanish version back forward translation
Change in Self-report psychological variables: interoceptive awareness (teens)
时间窗: Change in MAIA-2 from pre (Day 1) to post (Day 30). Change in MAIA-2 from post (Day 30) to follow up3 (Month 3). Change in MAIA-2 from follow up 3 (month 3) to follow up 6 (month 6).
- 32 items for teens: MAIA-Y (Joenes et al., 2020); Spanish version back forward translation and adapted to teens
change in Self-report psychological variables: self-criticism (caregivers)
时间窗: Change in FSCRS-SR from pre (Day 1) to post (Day 30). Change in FSCRS-SR from post (Day 30) to follow up3 (Month 3). Change in FSCRS-SR from follow up 3 (month 3) to follow up 6 (month 6).
- 14 items for caregivers: FSCRS-SR (Gilbert, Clarke, Hempel, Miles \& Irons, 2004); Spanish version back forward translation
Change in Self-report psychological variables: self-criticism (teens)
时间窗: Change in FSCRS-SR from pre (Day 1) to post (Day 30). Change in FSCRS-SR from post (Day 30) to follow up3 (Month 3). Change in FSCRS-SR from follow up 3 (month 3) to follow up 6 (month 6).
- 14 items for teens: FSCRS-SR (Gilbert, Clarke, Hempel, Miles \& Irons, 2004); Spanish version back forward translation and adapted to teens
次要结局
- Change in observational behavioural variable (caregiver-teen dyad)(Change in PCIM between pre (Day 1) and post (Day 30).)
- Change in ecological momentary assessment self kindness (teens)(Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).)
- Change in ecological momentary assessment: triggering event (caregivers)(Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).)
- change in ecological momentary assessment: positive impact on caregiver-teen interactions (caregivers and teens)(Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).)
- Change in ecological momentary assessment: affect (caregivers)(Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).)
- Change in ecological momentary assessment: self criticism (caregivers)(baseline (Day 1-Day11), post (Day 30-Day 34), follow up3 (Day 90-Day 104), and follow up6 (Day 180- Day194))
- change in metabolic outcome 1 (only teens)(Change in HbA1c from pre (Day 1) to post (Day 30). Change in HbA1c from post (Day 30) to follow up3 (Month 3). Change in HbA1c from follow up 3 (month 3) to follow up 6 (month 6).)
- Change in Self-report diabetes-related variables: the diabetes family conflict scale (caregivers)(Change in DFCS from pre (Day 1) to post (Day 30). Change in DFCS from post (Day 30) to follow up3 (Month 3). Change in DFCS from follow up 3 (month 3) to follow up 6 (month 6).)
- Change in Self-report diabetes-related variables: parental report on teen's health-related quality of life(Change in KIDSCREEN-10 from pre (Day 1) to post (Day 30). Change in KIDSCREEN-10 from post (Day 30) to follow up3 (Month 3). Change in KIDSCREEN-10 from follow up 3 (month 3) to follow up 6 (month 6).)
- Change in ecological momentary assessment self kindness (caregivers )(Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).)
- change in metabolic outcome 2 (only teens)(Change in TiR from pre (Day 1) to post (Day 30). Change in TiR from post (Day 30) to follow up3 (Month 3). Change in TiR from follow up 3 (month 3) to follow up 6 (month 6).)
- Change in Self-report diabetes-related variables: diabetes-specific emotional distress (teens)(Change in PAID-T from pre (Day 1) to post (Day 30). Change in PAID-T from post (Day 30) to follow up3 (Month 3). Change in PAID-T from follow up 3 (month 3) to follow up 6 (month 6).)
- Change in Self-report diabetes-related variables: the diabetes family conflict scale (teens)(Change in DFCS from pre (Day 1) to post (Day 30). Change in DFCS from post (Day 30) to follow up3 (Month 3). Change in DFCS from follow up 3 (month 3) to follow up 6 (month 6).)
- Change in ecological momentary assessment: affect (teens)(Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).)
- Change in Self-report diabetes-related variables: diabetes-specific emotional distress (caregivers)(Change in PAID-P from pre (Day 1) to post (Day 30). Change in PAID-P from post (Day 30) to follow up3 (Month 3). Change in PAID-P from follow up 3 (month 3) to follow up 6 (month 6).)
- change in ecological momentary assessment: negative impact on caregiver-teen interactions (caregivers and teens)(Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).)
- Practice frequency(during the intervention (Day11-Day 30))
- Change in ecological momentary assessment: self criticism (teens)(Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).)
- Change in ecological momentary assessment: emotion regulation (caregivers )(Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).)
- Change in ecological momentary assessment: triggering event (teens)(Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).)
- Change in ecological momentary assessment: emotion regulation (teens)(Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).)
- Possible adverse effects(Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).)