The T1D Talks Pilot Study

Официальное название

The T1D Talks Pilot Study: An Online Teen / Tween Group About Life With T1D and Managing the Emotions That Come With it

Обзор

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.

Вмешательства

• Поведенческое The T1D Talks: A Virtual Group for Teens and Tweens with T1D
  The T1D Talks intervention is an 11 session, virtual (online), group intervention. The T1D Talks intervention teaches developmentally appropriate emotion regulation (ER) skills and facilitates practicing these skills via role-plays and in-session experiences that are meant to elicit strong emotions. The investigators adapted the content and situations of an established intervention to be relevant for youth with T1D (e.g., practicing ER skills while role playing situations like telling parents ab

Первичные конечные точки

• Percent of participants who attended the intervention [Срок оценки: Through study completion, up to 12 weeks]
• Percent of participants who rated each session as acceptable [Срок оценки: Through study completion, up to 12 weeks]
• Percent of participants who rated the overall intervention as acceptable [Срок оценки: Through study completion, up to 12 weeks]

Вторичные конечные точки (9)

• Difficulties in Emotion Regulation- Short Form Scale [Срок оценки: Baseline to post-intervention, up to 11 weeks]
• Emotion Regulation Behaviors Scale (ERBS-R) [Срок оценки: Baseline to post-intervention, up to 11 weeks]
• Implicit Theories of Emotion Scale- Child Version (ITES-C) [Срок оценки: Baseline to post-intervention, up to 11 weeks]
• Affect Dysregulation Scale (ADS) [Срок оценки: Baseline to post-intervention, up to 11 weeks]
• Early Adolescent Temperament Questionnaire (EATQ-R select subscales) [Срок оценки: Baseline to post-intervention, up to 11 weeks]
• Problem Areas in Diabetes: Teen (PAID-T) [Срок оценки: Baseline to post-intervention, up to 11 weeks]
• Diabetes-related Executive Functioning Scale- short form (DREFS-SF) [Срок оценки: Baseline to post-intervention, up to 11 weeks]
• Diabetes-Specific Risk-Taking Inventory (DSRI) [Срок оценки: Baseline to post-intervention, up to 11 weeks]
• Diabetes Knowledge Questionnaire (DKQ) [Срок оценки: Baseline to post-intervention, up to 11 weeks]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• a chronic medical condition that requires intensive daily management
• a significant mental health or cognitive disability that would prevent them from participating

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Nemours Children's Hospital, Florida — Orlando

Идентификаторы

NCT: NCT07109128 · WMED1378 · 11-23-JDFBMH-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗