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Clinical Trials/NCT06499740
NCT06499740
Not yet recruiting
Not Applicable

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

University of Washington0 sites48 target enrollmentMay 1, 2026

Overview

Phase
Not Applicable
Intervention
Treatment as Usual
Conditions
Suicide Prevention
Sponsor
University of Washington
Enrollment
48
Primary Endpoint
Intervention Appropriateness Measure
Status
Not yet recruiting
Last Updated
12 days ago

Overview

Brief Summary

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.

Detailed Description

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 low to moderate risk 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.

Registry
clinicaltrials.gov
Start Date
May 1, 2026
End Date
March 1, 2028
Last Updated
12 days ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sarah Danzo

Assistant Professor, Department of Psychiatry and Behavioral Sciences

University of Washington

Eligibility Criteria

Inclusion Criteria

  • Adolescent Inclusion Criteria:
  • adolescent between the ages of 10 and 18 years old
  • speaks fluent English
  • current or past low to moderate suicide risk (denies current plan with intent to kill self)

Exclusion Criteria

  • high suicide risk (endorses current plan and intent)
  • 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:

Arms & Interventions

Treatment as usual

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.

Intervention: Treatment as Usual

Pilot Intervention

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.

Intervention: Pilot Intervention

Outcomes

Primary Outcomes

Intervention Appropriateness Measure

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.)

Secondary Outcomes

  • 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)

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