The T1D Talks Pilot Study

Part of paid clinical trials in Orlando, Florida.

Sponsor
Western Michigan University School of Medicine
Study ID
NCT07109128
Status
Enrolling By Invitation

Conditions

  • Type 1 Diabetes (T1D)

Eligibility Criteria

Sex
ALL
Age
12 Years - 14 Years
Healthy Volunteers
Not accepted

Interventions

  • The T1D Talks: A Virtual Group for Teens and Tweens with T1D — 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).

Study Details

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.

Key Dates

Start date
Feb 15, 2024
Status verified
Jul 2025
Primary completion
Nov 14, 2025
Completion
Nov 14, 2025

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: 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.

Primary Outcome Measure

Percent of participants who attended the intervention [ Time Frame: Through study completion, up to 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Nemours Children's Hospital, FloridaOrlandoFlorida32827-

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Nemours Children's Hospital, Florida· Orlando, FL

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