Crisis Interventions for Pediatric Providers - Autism Version

Официальное название

Safety Planning for Autistic Youth: A Randomized Controlled Trial With Providers in Pediatric Clinics

Обзор

The goal of this clinical trial is to examine the initial feasibility, acceptability, and effectiveness of Crisis Interventions for Pediatric Providers - Autism version (CIPP-A) for providers serving autistic youth in outpatient settings. The main question aims to answer: * Assess whether CIPP-A is feasible and acceptable to providers in development behavioral pediatric clinics? * Assess whether CIPP-A shows initial effectiveness in increasing providers confidence in managing suicide risk in autistic youth? If there is a comparison group: Researchers will compare CIPP-A to general safety planning intervention (SPI) on feasibility, acceptability, and initial effectiveness. Participants will be randomized to receive training in SPI or CIPP-A and complete online surveys and interviews over 6-months to measure feasibility, acceptability, and initial effectiveness.

Вмешательства

• Поведенческое Safety Planning Intervention
  The Safety Planning Intervention (SPI) is leading, evidence-based intervention that manages risks associated with suicidal thoughts and behaviors in youth. The SPI is delivered by providers to youth and their parents/guardians and focuses on teaching the family a series of safety planning steps to keep youth safe as they experience suicidal thoughts and/or behaviors. The SPI can be delivered by providers to families in person or virtually during clinic visits, and shows effectiveness in increasi
• Поведенческое Crisis Interventions for Pediatric Providers - Autism version (CIPP-A)
  The CIPP-A is an autism-specific crisis intervention for pediatric providers co-developed by the PI (licensed psychologist) and autistic people, which was published in Pediatrics. Similar to the SPI, CIPP-A is delivered by providers to youth and their parents and focuses on teaching the family a series of crisis interventions to keep youth safe as they experience suicidal thoughts and/or behaviors, with autism-specific adaptations. Autism-specific adaptations include warning signs (e.g., sensory

Первичные конечные точки

• Feasibility: Number of times that providers use SPI or CIPP-A in 6 months [Срок оценки: Baseline to 6 months]
• Acceptability: Acceptability of Intervention Measure [Срок оценки: Baseline to 6 months]
• Initial Effectiveness: Providers confidence in using SPI or CIPP-A [Срок оценки: Baseline to 6 months]

Вторичные конечные точки (3)

• Feasibility of Intervention Measure [Срок оценки: Baseline to 6 months]
• Fidelity of implementation [Срок оценки: 6 months]
• Semi-structured interview to assess intervention feasibility [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Pediatric healthcare providers serving autistic youth in a DBP clinic in the U.S.
• Willing and able to participate in the study and its activities, including remote training in either SPI or CIPP-A (depending on randomization)
• Willing and able to provide informed consent
• Comfortable speaking or communicating in English

Критерии исключения

• Pediatric healthcare providers not serving autistic youth
• Pediatric healthcare providers not practicing in a DBP clinic in the U.S.
• Unwilling and unable to participate in the study and its activities
• Unwilling and unable to provide informed consent
• Not comfortable speaking or communicating in English

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Children's Hospital Los Angeles — Los Angeles

Идентификаторы

NCT: NCT07508436 · CHLA-25-00359 · 6UM4MC54988-01-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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