The T1D Talks Pilot Study: An Online Teen / Tween Group About Life With T1D and Managing the Emotions That Come With it
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Percent of participants who attended the intervention
研究概览
简要总结
Despite recent technological advances in type 1 diabetes (T1D) treatment, adolescents are the only age group for which glycemic levels have not improved. Technology and education help adolescents execute the mechanics of managing blood glucose levels, but do not help adolescents manage the emotional distress that arises when T1D management goals conflict with social/emotional goals (e.g., taking insulin for a meal in front of new friends vs. trying to "fit-in"). The emotional distress caused by such situations can be difficult to manage and can lead to unhealthy risk behaviors and disengagement in T1D self-management (e.g., deciding to skip a lunch-time bolus to avoid bolusing in front of new friends).
A novel approach in T1D research is to target emotions directly by promoting emotion regulation skills. In the general population, emotion regulation interventions have demonstrated success in preventing both unhealthy behaviors and mood disorders among younger adolescents, including younger adolescents with social-emotional risk-factors like low SES. The investigators' scientific premise is that an emotion regulation intervention for younger adolescents with T1D (age 12-14) could promote skills to help youth manage emotional burdens of living with T1D, reduce unhealthy and risky T1D self-management behaviors, and prevent unhealthy patterns of behaviors and distress/mood disorders that often appear in later adolescence.
Using the ORBIT Model, a systematic framework for developing behavioral interventions for people with chronic diseases, the investigators adapted an evidence-based, manualized emotion regulation intervention for young adolescents, so that it is relevant for youth with T1D. The current study is a natural extension of this previous work. For the current study, the investigators propose to complete a feasibility and acceptability trial of this novel emotion regulation intervention for youth with T1D.
The investigators aimed to pilot the novel emotion regulation intervention (11 virtual group sessions) with 3 sequential groups of 6-8 young adolescents (age 12-14) with T1D in each group and obtain feedback from facilitators and participants and their parents after each session, and after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T1D for at least 1 year
- •the ability to read/write and converse in English
- •reliable internet connection and a virtual meeting capable device (tablet or laptop)
排除标准
- •a chronic medical condition that requires intensive daily management
- •a significant mental health or cognitive disability that would prevent them from participating
结局指标
主要结局
Percent of participants who attended the intervention
时间窗: Through study completion, up to 12 weeks
Feasibility will be demonstrated by average individual participation in at least 70% of the sessions, and \>70% of participants completing the intervention by participating in the last session.
Percent of participants who rated each session as acceptable
时间窗: Through study completion, up to 12 weeks
The percentage of participants who rated each session as "acceptable" on a post-session survey rating scales that were developed for this study. 6 items on the session evaluation survey assess the following: relevance, trust in the information, ease of understanding, learning novel information, and interest in topics. Item responses include a 5-point Likert scale from "strongly disagree to strongly agree". The research team will average participant's responses across the items, thus total score could be a minimum of 1 and a maximum of 5, with a higher score indicating higher acceptability of the intervention. The intervention will be considered acceptable if ≥ 70% of participants rate each session as acceptable, as indicated by a total score \>3.
Percent of participants who rated the overall intervention as acceptable
时间窗: Through study completion, up to 12 weeks
The percentage of participants who rated the intervention, as a whole, as "acceptable" on a post-intervention survey rating scales that were developed for this study. 16 items on the intervention evaluation survey assess, one's perceptions of the intervention. Item responses include a 5-point Likert scale from "strongly disagree to strongly agree". The research team will reverse score items that negatively worded and average participant's responses across the items, thus total score could be a minimum of 1 and a maximum of 5, with a higher score indicating higher acceptability of the intervention. The intervention will be considered acceptable if ≥ 70% of participants rate the intervention as acceptable, as indicated by a total score \>3.
次要结局
- Difficulties in Emotion Regulation- Short Form Scale(Baseline to post-intervention, up to 11 weeks)
- Emotion Regulation Behaviors Scale (ERBS-R)(Baseline to post-intervention, up to 11 weeks)
- Implicit Theories of Emotion Scale- Child Version (ITES-C)(Baseline to post-intervention, up to 11 weeks)
- Affect Dysregulation Scale (ADS)(Baseline to post-intervention, up to 11 weeks)
- Diabetes-related Executive Functioning Scale- short form (DREFS-SF)(Baseline to post-intervention, up to 11 weeks)
- Early Adolescent Temperament Questionnaire (EATQ-R select subscales)(Baseline to post-intervention, up to 11 weeks)
- Diabetes Knowledge Questionnaire (DKQ)(Baseline to post-intervention, up to 11 weeks)
- Problem Areas in Diabetes: Teen (PAID-T)(Baseline to post-intervention, up to 11 weeks)
- Diabetes-Specific Risk-Taking Inventory (DSRI)(Baseline to post-intervention, up to 11 weeks)
研究者
Rachel Wasserman
Associate Professor
Western Michigan University School of Medicine