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NCT06752369Recruiting

Adapting Single Sessions Interventions for Type 1 Diabetes

Adapting Single Sessions Interventions for Type 1 Diabetes (ASSISTED): Integrated Pediatric Care to Reduce Depression and HbA1c

Source: ClinicalTrials.gov · Last updated 24 Jul 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Interventional
Enrollment
80 (estimated)
First submitted
20 Dec 2024
Start date
3 Aug 2026
Primary completion date
Aug 2028
Lead sponsor
Nemours Children's Health System
NCT number
NCT06752369

What you commit to

  • Study type: Interventional
  • Planned participants: 80
  • From 3 Aug 2026 to the primary completion date, Aug 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

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

Other

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

Who the study is looking for

  • 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
  • English fluency

Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Nemours Children's Hospital - FL
Coordinator of this site? Confirm its status
OrlandoUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.