Adapting Single Sessions Interventions for Type 1 Diabetes

Last updated: December 27, 2024
Sponsor: Nemours Children's Health System
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Prevention

Diabetes Mellitus, Type 1

Treatment

T1D Educational

T1D-specific depression SSI

Clinical Study ID

NCT06752369
K23DK139431
K23DK139431
  • Ages 12-17
  • All Genders

Study Summary

The goal of this clinical trial is to learn if implementing a single-session depression intervention for youth with type 1 diabetes (T1D) is feasible and acceptable to patients. can help improve mood and health outcomes. It will also learn about the initial efficacy of the intervention. The main questions it aims to answer are:

  1. Is a single-session depression intervention for youth with T1D feasible to recruit and implement?

  2. Is a single-session depression intervention for youth with T1D acceptable to patients (i.e., do they find it helpful)?

  3. Does a single-session depression intervention for youth with T1D lead to improvements in low mood?

Researchers will compare a single-session depression intervention for youth with to a education control to see if a single-session depression intervention works to improve depressive symptoms.

Participants will:

  • Participate in a single-session depression intervention

  • Complete questionnaires and provide a sample for A1c at a baseline, 3-month, and 6-month visit

  • Complete daily questionnaires once a day for two weeks before and after the single-session depression intervention

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Child or adolescent age between 11-18 years, inclusive

  • Physician confirmed T1D diagnosis of at least 6 months duration prior to studyenrollment

  • Positive depression screening score of >5 on the PHQ-9 in the last year

  • Not currently engaged in outpatient mental healthcare

  • English fluency

Exclusion

Exclusion Criteria:

  • Another systemic chronic medical illness except for celiac disease, autoimmunethyroiditis, microalbuminuria, hypertension, or well-managed asthma

  • Any score of 1, 2, or 3 on item 9 (indicating suicidal ideation) of the PHQ-9 in thelast year.

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: T1D Educational
Phase:
Study Start date:
February 01, 2025
Estimated Completion Date:
February 28, 2029

Connect with a study center

  • Nemours Children's Hospital - FL

    Orlando, Florida 32827
    United States

    Site Not Available

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