跳至主要内容
临床试验/NCT07197476
NCT07197476招募中不适用

Adolescent Injury: Intervening to Prevent Posttraumatic Stress and Substance Use Outcomes

Rhode Island Hospital1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2026年3月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
92
试验地点
1
主要终点
To develop and refine two ASSIST video interventions for adolescents and parents admitted to a level 1 pediatric trauma center.

研究概览

简要总结

The long-term goal of this study is to address the adoption of the new trauma center requirement to establish best practices of screening for acute stress with an intervention to prevent both adolescent PTSD and substance use. The investigators will develop, refine, and pilot test the Adolescent Stress and Substance Intervention Subsequent to Trauma (ASSIST) video interventions that build upon the American College of Surgeons Committee on Trauma guidelines to improve mental health care during and after hospitalization for traumatic injury. The aims are:

PHASE I - Primary Aim 1: To develop and refine two ASSIST video interventions for adolescents and parents admitted to a level 1 pediatric trauma center.

PHASE II

  • Primary Aim 2a: To evaluate the feasibility, acceptability and implementation potential of the ASSIST video interventions.
  • Primary Aim 2b: Develop the ASSIST implementation protocol using a national advisory panel of pediatric trauma center leaders.

Participants in PHASE 1:

Parent and child duo:

  • Review storyboards for the video interventions
  • Participate in qualitative interviews at hospital admission and 1 month following discharge

Pediatric trauma center clinical staff members:

- Complete qualitative interviews

Participants in PHASE II:

Parent and child duo:

  • Shown their own video interventions
  • Complete assessments at admission and 1-, 2-, 3- months after discharge

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Must be 12-17 years
  • •Fluent in English or Spanish
  • •Able to provide informed assent
  • •Have a parent able to provide informed consent
  • •Inclusion Criteria for Parents:
  • •Live with an admitted pediatric trauma patient
  • •Fluent in English or Spanish
  • •Able to provide informed consent

排除标准

  • •Prisoner or in police custody
  • •Involvement with child protective services
  • •Admitted due to suicide attempt or non-suicidal self-injury
  • •Any acute condition that would preclude provision of informed consent or assent

研究组 & 干预措施

Develop and Pilot Test ASSIST Video Intervention

Experimental

The investigators will develop and pilot test the Adolescent Stress and Substance Intervention Subsequent to Trauma (ASSIST) video intervention that builds upon ACS-COT guidelines to improve mental health care during and after hospitalization for traumatic injury. The ASSIST video intervention is a simple, cost-effective, and scalable tool that may be easily integrated into usual care settings to address posttraumatic symptoms and decrease risk of subsequent substance use following discharge.

干预措施: ASSIST Video Intervention (Behavioral)

结局指标

主要结局

To develop and refine two ASSIST video interventions for adolescents and parents admitted to a level 1 pediatric trauma center.

时间窗: Single interaction for enrollment and qualitative interview up to 45 minutes

Elicit feedback from content experts to further refine initial ASSIST video interventions. Conduct qualitative interviews with 15-20 parents and adolescents (12-17 years) to assess perceived usefulness of, and satisfaction with, intervention content as well as elicit feedback on areas for future refinement. Conduct qualitative interviews with 9-12 key stakeholders in the fields of pediatric trauma care to assess clinical concerns/strategies as well as implementation barriers/facilitators.

To evaluate the feasibility, acceptability, and implementation potential of the ASSIST video interventions.

时间窗: From enrollment to the end of the surveys and exit interview at 3 months

Examine the feasibility and acceptability of the ASSIST videos, over a 3-month period, as measured by rates of enrollment and retention, interest/satisfaction, knowledge regarding mental health symptoms/substance use, incidence (quantity/frequency) of substance use, self-efficacy in having discussions about mental health symptoms/ substance use, self-efficacy around connecting participant's child to mental health and/or addiction resources, (when appropriate) engagement with a provider for mental health and/or addiction care. These will be assessed in the form of self-administered surveys and a qualitative exit interview.

Develop the ASSIST implementation protocol

时间窗: 3 months

Develop the ASSIST implementation protocol using a national advisory panel of pediatric trauma center leaders. Using an expert panel from the national cohort of pediatric trauma centers the investigators have worked with in a previous implementation trial, and pilot data from the investigators' institution, an implementation protocol will be developed that will be tested in a subsequent fully powered R01 hybrid implementation-efficacy trial.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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