Adapting Single Sessions Interventions for Type 1 Diabetes

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorNemours Children's Health System

About this trial

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

Qualifiers

Child or adolescent age between 11-18 years, inclusive

Physician confirmed T1D diagnosis of at least 6 months duration prior to study enrollment

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

Not currently engaged in outpatient mental healthcare

Disqualifiers

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

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

Trial design

Treatments tested in this trial

  • T1D-specific depression SSI
  • T1D Educational

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Nemours Children's Health System

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator