Clinical trial NCT06752369: Adapting Single Sessions Interventions for Type 1 Diabetes
Official title: Adapting Single Sessions Interventions for Type 1 Diabetes (ASSISTED): Integrated Pediatric Care to Reduce Depression and HbA1c
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 1 Diabetes (T1D)
Keywords: type 1 diabetes
adolescents
depression
Lead sponsor: Nemours Children's Health System
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-12-30
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Hemoglobin A1c (HbA1c)
timeFrame: 0, 3-months, and 6-months
measure: Patient Health Questionnaire for Adolescents (PHQ-9)
timeFrame: 0, 3-months, and 6-months
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: 7 days before and 7 days after SSI
measure: Mood and Feelings Questionnaire (MFQ)
timeFrame: 7 days before and 7 days after SSI
measure: Feasibility of T1D-specific Depression SSI
timeFrame: Baseline and 3-months
measure: Acceptability of Healthcare Interventions Questionnaire
timeFrame: immediately after SSI completion
Secondary outcomes:
measure: Problem Areas in Diabetes- Teen (PAID-T)
timeFrame: 0, 3-months, and 6-months
measure: Diabetes Family Conflict Scale- Revised (DFCS-R)
timeFrame: 0, 3-months, and 6-months
measure: Diabetes Strengths and Resilience Measure for Adolescents (DSTAR-Teen)
timeFrame: 0, 3-months, 6-months
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Nemours Children's Hospital - FL
state: Florida
Study officials:
References: