Adapting Single Sessions Interventions for Type 1 Diabetes

Официальное название

Adapting Single Sessions Interventions for Type 1 Diabetes (ASSISTED): Integrated Pediatric Care to Reduce Depression and HbA1c

Обзор

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

Вмешательства

• Поведенческое T1D-specific depression SSI
  The T1D-specific depression SSI will include 1) psychoeducation about depression, including how behavior shapes feelings and thoughts, 2) a values assessment, where youth will identify key areas (i.e., family relationships, friendships, school, or hobbies) from which they draw (or once drew) enjoyment and meaning, and 3) the creation of an activity action plan, wherein youth identify (from pre-generated lists) and personalize (in guided exercises) three activities to target for change.
• Поведенческое T1D Educational
  T1D Educational Material

Первичные конечные точки

• Hemoglobin A1c (HbA1c) [Срок оценки: 0, 3-months, and 6-months]
• Patient Health Questionnaire for Adolescents (PHQ-9) [Срок оценки: 0, 3-months, and 6-months]
• Positive and Negative Affect Schedule (PANAS) [Срок оценки: 7 days before and 7 days after SSI]
• Mood and Feelings Questionnaire (MFQ) [Срок оценки: 7 days before and 7 days after SSI]
• Feasibility of T1D-specific Depression SSI [Срок оценки: Baseline and 3-months]
• Acceptability of Healthcare Interventions Questionnaire [Срок оценки: immediately after SSI completion]

Вторичные конечные точки (3)

• Problem Areas in Diabetes- Teen (PAID-T) [Срок оценки: 0, 3-months, and 6-months]
• Diabetes Family Conflict Scale- Revised (DFCS-R) [Срок оценки: 0, 3-months, and 6-months]
• Diabetes Strengths and Resilience Measure for Adolescents (DSTAR-Teen) [Срок оценки: 0, 3-months, 6-months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Nemours Children's Hospital - FL — Orlando

Идентификаторы

NCT: NCT06752369 · K23DK139431 · K23DK139431

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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