The T1D Talks Pilot Study

Western Michigan University School of Medicine

Status: Invitation-only

Conditions: Type 1 Diabetes (T1D)

Treatments: Behavioral: The T1D Talks: A Virtual Group for Teens and Tweens with T1D

Study type: Interventional

Funder types: Other

Identifiers

NCT07109128

WMED1378

11-23-JDFBMH-03 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 12 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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18 participants in 1 patient group

The T1D Talks Virtual Group Intervention for Teens and Tweens with T1D

Experimental group

Description:

Experimental: The T1D Talks Group Intervention. This is the intervention, as this is a proof of concept pilot study, we will only have an intervention arm.

Treatment:

Behavioral: The T1D Talks: A Virtual Group for Teens and Tweens with T1D