跳至主要内容
临床试验/NCT06499740
NCT06499740招募中不适用

Adapting a Brief Suicide Intervention for Pediatric Primary Care: Enhancing Uptake and Impact

University of Washington3 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2026年5月4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
48
试验地点
3
主要终点
Intervention Appropriateness Measure

研究概览

简要总结

Suicide is a leading cause of death among adolescents in the United States and improving access to high quality just-in-time suicide interventions to reduce risk has important public health implications. Integrating such interventions into routinely accessed settings, such as pediatric primary care, holds promise; however, many clinicians in these settings fail to adequately screen or intervene in youth suicidal thoughts and behaviors, representing a key barrier to reducing suicide. The proposed study is a pre-post quasi-experimental pilot feasibility and preliminary efficacy trial of a suicide prevention intervention informed by evidence based interventions including the SAFETY-Acute suicide prevention intervention implemented in 3 pediatric primary care clinics.

详细描述

This project aims to take an innovative, user-centered design approach to improve suicide prevention in primary care settings to support primary care management of adolescents with suicidal thoughts and behaviors (STB), drawing on the evidence-based SAFETY-Acute (SAFETY-A; formerly known as Family Intervention for Suicide Prevention -aka FISP) intervention. In this trial, the investigators will conduct a pre-post quasi-experimental pilot feasibility and preliminary efficacy study of an adapted STB model of care compared to treatment as usual, with 3 primary care clinics. The trial will include 48 10-18-year-old patients with STB and their parents/caregivers. The investigators will assess acceptability and feasibility of the STB model of care, preliminary intervention impacts, and need for further adaptation.

研究设计

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

入排标准

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

入选标准

  • Adolescent Inclusion Criteria:
  • adolescent between the ages of 10 and 18 years old
  • speaks fluent English
  • current or recent suicide risk

排除标准

  • high suicide risk (in need of immediate crisis stabilization services such as inpatient medical or psychiatric hospitalization)
  • does not speak fluent English
  • does not have a primary care provider
  • Caregiver Inclusion Criteria:
  • has a child who meets inclusion criteria
  • Age 18 years or older
  • Caregiver Exclusion Criteria:
  • does not have a child who meets inclusion criteria
  • does not speak English
  • Provider Inclusion Criteria:
  • Age 18 years or older
  • works in primary care/outpatient healthcare setting

研究组 & 干预措施

Treatment as usual

Active Comparator

Arm 1 entails months 1-2 of this study. Treatment as usual will be delivered by providers to adolescent patients in their clinics during the first two months of this study. Treatment as usual will be defined by each individual clinic based on their existing clinic protocols.

干预措施: Treatment as Usual (Behavioral)

Pilot Intervention

Experimental

Arm 2 entails months 3-4 of this study. Participating providers will deliver the adapted pilot intervention for the second half (months 3-4) of the pilot trial. The intervention will be based on the evidence-based suicide prevention interventions including the SAFETY-Acute protocol and will be adapted based on information from potential users prior to piloting. It is anticipated that both adolescent patients and their parents/caregivers will be involved in the intervention. Anticipated components of the intervention include psychoeducation, coping skills, safety planning, lethal means restriction, parenting skills, communication skills, identifying adolescent and family strengths, and linking to longer term care.

干预措施: Pilot Intervention (Behavioral)

结局指标

主要结局

Intervention Appropriateness Measure

时间窗: Participant and providers complete approximately 2 weeks after completing intervention

Participant rated appropriateness of the intervention (includes 4 items scored on a 5 point likert scale with higher scores representing greater appropriateness.)

Feasibility of Intervention Measure

时间窗: Participant and providers complete approximately 2 weeks after completing intervention

Feasibility of the intervention (includes 4 items scored on a 5 point likert scale with higher scores representing greater feasibility.)

Intervention Usability Scale

时间窗: Participant/provider completes approximately 2 weeks after completing intervention

Participant rated intervention usability (includes 10 items scored on a 5 point likert scale with greater total score representing greater usability).

Acceptability of Intervention Measure

时间窗: Participant and providers complete approximately 2 weeks after completing intervention

Participant rated acceptability of the intervention (includes 4 items scored on a 5 point likert scale with higher scores representing greater acceptability.)

Youth Satisfaction Questionnaire

时间窗: Participant completes approximately 2 weeks after completing intervention

Adolescent participant rated satisfaction with the intervention (includes 5 items scored on a 3 point likert scale with higher scores representing greater satisfaction.)

Client Satisfaction Questionnaire

时间窗: Participant completes approximately 2 weeks after completing intervention

Participant rated satisfaction with the intervention (includes 8 items scored on a 4 point likert scale with higher scores representing greater satisfaction.)

Intervention Usability Scale

时间窗: Provider completes approximately 2 weeks after completing intervention

Participant rated intervention usability (includes 10 items scored on a 5 point likert scale with greater total score representing greater usability).

次要结局

  • Parent Self Efficacy Scale(Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention)
  • Adapted General Self-Efficacy Scale(Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention)
  • adapted Child Parent Relationship Scale(Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention)
  • Adult Child Relationship Scale (ACRS)/Child Parent Relationship Scale (CPRS)(Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention)

研究者

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

Sarah Danzo

Assistant Professor, Department of Psychiatry and Behavioral Sciences

University of Washington

研究点 (3)

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