The T1D Talks Pilot Study

NCT ID: NCT07109128

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-15
• Study Completion Date: 2025-11-14

Brief Summary

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.

Conditions

Type 1 Diabetes (T1D)

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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 about high blood glucose numbers or telling a coach about needing to take a time out from a game because of a low blood glucose level). The intervention also provides basic diabetes education about risky situations (e.g., how physical activity can affect blood glucose).

Interventions

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 about high blood glucose numbers or telling a coach about needing to take a time out from a game because of a low blood glucose level). The intervention also provides basic diabetes education about risky situations (e.g., how physical activity can affect blood glucose).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nemours Children's Health System

OTHER

Sponsor Role: collaborator

Western Michigan University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Rachel Wasserman

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rachel Wasserman, PhD

Role: PRINCIPAL_INVESTIGATOR

Western Michigan University Homer Stryker MD School Of Medicine

Locations

Nemours Children's Hospital, Florida

Orlando, Florida, United States

Countries

United States

Other Identifiers

11-23-JDFBMH-03

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

WMED1378

Identifier Type: -

Identifier Source: org_study_id