Improving Mood for Adolescents Through Teaming With End-Users in Routine Care (The iMATTER Project)

Официальное название

The iMATTER Project: Preventing Adolescent Depression in Pediatric Primary Care

Обзор

This pilot randomized controlled trial will examine the feasibility, acceptability and preliminary efficacy of an adolescent depression prevention program, Brief Interpersonal Psychotherapy-Adolescent Skills Training (B-IPT-AST), in primary care.

Подробное описание

Depression is prevalent during adolescence and is associated with negative outcomes. Most adolescent depression prevention programs require significant time and resources. To reduce the research-to-practice gap, the present study will test an adapted version of an evidence-based depression preventive intervention, Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST), to promote its implementation in primary care (PC). Specifically, a brief, scalable prevention program, Brief IPT-AST (B-IPT-AST), will be tested in a pilot randomized controlled trial in PC. The pilot randomized controlled trial will include adolescents ages 13-17 with subthreshold depression scores on a depression screener, the Patient Health Questionnaire 9-Item: Modified for Teens (PHQ-9-M), completed during an annual PC well-visit. Adolescents will be randomly assigned (2:1 allocation) to B-IPT-AST or services as usual (SAU). Members of the research team will deliver B-IPT-AST. Standardized measures for adolescents and legal guardians will be used to examine emotional outcomes (e.g., depression and anxiety symptoms). Standardized measures will be utilized to assess social processes (e.g., interpersonal conflict). All adolescents randomized to B-IPT-AST will complete a survey measuring acceptability of B-IPT-AST. Additionally, a subset of adolescents who participate in B-IPT-AST will be invited to participate in an hour-long qualitative interview to give feedback on their experiences with B-IPT-AST to inform any further modifications needed to enhance the program's feasibility and acceptability. Feasibility will also be assessed via recruitment and retention information and B-IPT-AST attendance logs.

Вмешательства

• Поведенческое Brief Interpersonal Psychotherapy - Adolescent Skills Training (B-IPT-AST)
  This is an adolescent depression prevention program consisting of 6 sessions (4 group and 2 individual sessions).
• Поведенческое Services as usual (SAU)
  Services as usual (SAU) involves any mental health services adolescents decide to receive in primary care or in the community. It is possible that adolescents in SAU may decide not to participate in any mental health services.

Первичные конечные точки

• Acceptability: A self-report measure, the Attitude Towards Intervention Questionnaire (ATI) [Срок оценки: 0-6 Weeks Post-Intervention]
• Attendance [Срок оценки: Weekly during B-IPT-AST]
• Retention [Срок оценки: Baseline, 0-6 Weeks Post-Intervention]
• Depression symptoms [Срок оценки: Baseline, 0-6 Weeks Post-Intervention]
• Depression symptoms [Срок оценки: Baseline, 0-6 Weeks Post-Intervention]
• Anxiety symptoms [Срок оценки: Baseline, 0-6 Weeks Post-Intervention]

Вторичные конечные точки (7)

• Internalizing and externalizing symptoms [Срок оценки: Baseline, 0-6 Weeks Post-Intervention]
• Impairment (Child Report) [Срок оценки: Baseline, 0-6 Weeks Post-Intervention]
• Impairment (Parent Report) [Срок оценки: Baseline, 0-6 Weeks Post-Intervention]
• Perspective-taking [Срок оценки: Baseline, 0-6 Weeks Post-Intervention]
• Social functioning [Срок оценки: Baseline, 0-6 Weeks Post-Intervention]
• Parent-child conflict (child report) [Срок оценки: Baseline, 0-6 Weeks Post-Intervention]
• Parent-child conflict (parent report) [Срок оценки: Baseline, 0-6 Weeks Post-Intervention]

Критерии участия

Критерии включения

For Adolescent Participants

• Adolescents ages 13 to 17 years.
• Adolescents must be English-speaking.
• Legal guardian permission (informed consent) and child consent/assent.
• A score of 5-10 on the Patient Health Questionnaire 9-Item: Modified for Teens (PHQ-9-M) at the primary care well-visit.
• Access to a phone, computer, or other electronic device that could be used for study activities

For Legal guardian Participants

• Legal guardian of an adolescents ages 13 to 17 years who scored 5-10 on the PHQ-9-M at the primary care well-visit.
• Consent to participate.
• English-speaking.
• Access to a phone, computer, and/or tablet to complete remote evaluations.

Критерии исключения

Exclusion criteria will be determined based on electronic health record (EHR) review, eligibility screening questions, the baseline evaluation, and any other interactions with the family.

• Suicidal ideation or behaviors reported on the PHQ-9-M at their well-visit (score of 1 or higher on item 9 "In the past week, have you had thoughts that you would be better off dead, or of hurting yourself in some way?" and/or yes to either of the supplemental questions which ask, "Has there been a time in the past month when you have had serious thoughts about ending your life?" and "Have you ever, in your whole life, tried to kill yourself or made a suicide attempt?") based on medical record review. For the PHQ-9-M administered at baseline, adolescents who mark yes to the supplemental item about serious suicidal ideation in the past month ("Has there been a time in the past month when you have had serious thoughts about ending your life?") will be excluded.
• Major medical illness, significant behavioral problems or intellectual or developmental disabilities that may interfere with the completion of all study procedures.
• Youth may be excluded on a case-by-case basis if the EHR review, eligibility screener, baseline evaluation, or other interactions with the family suggests that the group program would not be appropriate.

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

Профилактика

Центры проведения

США · 1 центр

• Children's Hospital of Philadelphia — Philadelphia

Идентификаторы

NCT: NCT07020572 · 24-023018

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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