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
- Diseases
- Type 1 diabetes
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nemours Children's Hospital - FL Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.