Single-Session Depression Help for Teens with Type 1 Diabetes
Official title: Adapting Single Sessions Interventions for Type 1 Diabetes (ASSISTED): Integrated Pediatric Care to Reduce Depression and HbA1c
Run by Nemours Children's Health System · NCT06752369 · Data updated 2026-11-12
This study tests whether a one-time depression intervention is feasible and helpful for adolescents with Type 1 diabetes compared with standard diabetes education.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 12 Years to 17 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Nemours Children's Health System Academic / other |
| Locations | 1 site (Orlando, Florida) |
| Status | Recruiting |
| Started | August 3, 2026 |
| Main results expected | August 2028 |
| Study ends | February 2029 |
| Registry record updated | July 24, 2026 |
| Trial ID | NCT06752369 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adolescents aged 11-18 with a confirmed T1D duration of at least 6 months and a recent positive depression screen who are not currently in outpatient mental healthcare and are fluent in English.
✕Probably not a fit
Teens with suicidal ideation, additional systemic illnesses beyond well-controlled comorbidities, or those already receiving ongoing mental health care may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study enrolls youths aged 11-18 with Type 1 diabetes who screen positive for depressive symptoms. Participants receive a single-session depression-focused intervention tailored for T1D or a diabetes education control, with assessments at baseline and follow-up including mood measures and an A1c sample. The study aims to assess feasibility, acceptability, and preliminary effects on depressive symptoms, while comparing the two approaches. Recruitment and implementation in a real-world clinical setting will be evaluated, along with participant feedback on usefulness. No long-term efficacy claims are made beyond initial outcomes.
Why it matters
Potential benefit: If successful, the approach could provide a quick, acceptable way to support mood in teens with T1D and potentially improve health-related outcomes.
How similar studies have gone: Previous work suggests brief, targeted psychological strategies can help mood, but this specific single-session approach in youth with T1D is novel and exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where it's running
-
Nemours Children's Hospital - FL
Orlando, Florida, United States Recruiting
Study contacts
- Study coordinator: Alexandra Monzon, PhD
- Email: Alexandra.Monzon@nemours.org
- Phone: 904-603-6780
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.