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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 weeks
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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"
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a one-session program for low mood in youth ages 11–18 with type 1 diabetes. Researchers will compare it with an education program to see if it helps improve mood. They will also study whether the program is practical to offer and whether patients find it helpful.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 11–18 years.
  • Have type 1 diabetes confirmed by a doctor for at least 6 months.
  • Scored above 5 on the PHQ-9, a depression screening survey, in the past year.
  • Not currently getting outpatient mental health care, such as visits with a therapist.
  • Fluent in English.

Who can't join

  • Have another long-term illness affecting the body. Exceptions are celiac disease (an illness triggered by gluten), autoimmune thyroiditis (the immune system attacks the thyroid), microalbuminuria (small amounts of protein in urine), high blood pressure, or well-controlled asthma.
  • Scored 1, 2, or 3 on question 9 of the PHQ-9 in the past year, showing thoughts of suicide.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

FL