The T1D Talks Pilot Study

NCT07109128 | Enrolling By Invitation

• 2 other identifiers: WMED137811-23-JDFBMH-03
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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)

Keywords

adolescents; emotion regulation; group; virtual

Outcome Measures

Primary Outcomes (3)

• Percent of participants who attended the intervention

  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.

  Through study completion, up to 12 weeks

• Percent of participants who rated each session as acceptable

  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.

  Through study completion, up to 12 weeks

• Percent of participants who rated the overall intervention as acceptable

  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.

  Through study completion, up to 12 weeks

Secondary Outcomes (9)

• 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

• Early Adolescent Temperament Questionnaire (EATQ-R select subscales)

  Baseline to post-intervention, up to 11 weeks

Study Arms (1)

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

EXPERIMENTAL

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.

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

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).

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

Eligibility Criteria

• Age: 12 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Western Michigan University School of Medicine: lead
• Nemours Children's Health System: collaborator

Study Sites (1)

Nemours Children's Hospital, Florida

Orlando, Florida, 32827, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Emotional Regulation

Interventions

Polysorbates

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Rachel Wasserman, PhD

  Western Michigan University Homer Stryker MD School Of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 3 sequential trials of a novel behavioral intervention

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: August 7, 2025
• Study Start: February 15, 2024
• Primary Completion: November 14, 2025
• Study Completion: November 14, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: The investigators will share this data by May 2027, either within 6 months of publication or within 18 months of the conclusion of the funding period (November 14, 2025), if the study remains unpublished.
• Access Criteria: Public use and restricted access study data and associated documentation will be made available to the research community free of charge through openICPSR, (https://www.openicpsr.org/openicpsr/) which is a self-publishing repository for social, behavioral, and health sciences research data.

Locations

US (1)