NCT06752369 Adapting Single Sessions Interventions for Type 1 Diabetes
| NCT ID | NCT06752369 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nemours Children's Health System |
| Condition | Type 1 Diabetes (T1D) |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-08-03 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2026-08-03 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06752369 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 17 Years, studying Type 1 Diabetes (T1D). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06752369 currently recruiting?
Yes, NCT06752369 is actively recruiting participants. Contact the research team at Alexandra.Monzon@nemours.org for enrollment information.
Where is the NCT06752369 trial being conducted?
This trial is being conducted at Orlando, United States.
Who is sponsoring the NCT06752369 clinical trial?
NCT06752369 is sponsored by Nemours Children's Health System. The trial plans to enroll 80 participants.
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