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临床试验/NCT07508436
NCT07508436尚未招募不适用

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

Children's Hospital Los Angeles1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
试验地点
1
主要终点
Feasibility: Number of times that providers use SPI or CIPP-A in 6 months

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Safety Planning Intervention

Active Comparator

The SPI is a brief, evidence-based suicide prevention intervention for youth and adults that can be delivered by diverse providers.

干预措施: Safety Planning Intervention (Behavioral)

Crisis Interventions for Pediatric Providers - Autism version (CIPP-A)

Experimental

The CIPP-A is a brief suicide prevention intervention for youth and adults that can be delivered by diverse providers and has been adapted for autistic youth.

干预措施: Crisis Interventions for Pediatric Providers - Autism version (CIPP-A) (Behavioral)

结局指标

主要结局

Feasibility: Number of times that providers use SPI or CIPP-A in 6 months

时间窗: Baseline to 6 months

The feasibility of SPI and CIPP-A will be assessed by an online survey of the number of times that providers used SPI/CIPP-A with autistic patients in 6 months. Higher scores indicate greater feasibility and use of SPI/CIPP-A (i.e., better outcome).The survey will be administered three times from baseline to 6 months.

Acceptability: Acceptability of Intervention Measure

时间窗: Baseline to 6 months

The Acceptability of Intervention Measure (AIM) will be administered to providers to assess perceived acceptability of SPI and CIPP-A. The AIM is a widely used measure of the extent to which stakeholders believe an intervention is satisfactory in a given setting (e.g., "I like SPI"). The AIM items are scored on a 5-point scale (1, completely disagree to 5, completely agree), with total scores ranging from 5-25. Higher scores indicate greater acceptability (i.e., better outcome). The AIM will be administered three times from baseline to 6 months.

Initial Effectiveness: Providers confidence in using SPI or CIPP-A

时间窗: Baseline to 6 months

A series of visual analog scales (VAS; 0-100%) will be used to measure changes in providers' confidence in managing patient crises over the study, with total scores ranging from 0-100. Higher scores indicate greater effectiveness (i.e., better outcome). The VAS will be administered three times from baseline to 6 months.

次要结局

  • Feasibility of Intervention Measure(Baseline to 6 months)
  • Fidelity of implementation(6 months)
  • Semi-structured interview to assess intervention feasibility(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jessica Schwartzman

Medical Staff/USC Faculty CWR

Children's Hospital Los Angeles

研究点 (1)

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