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

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.

Study Overview

• Status: Recruiting
• Conditions: Suicide Prevention
• Intervention / Treatment: Behavioral: Treatment as Usual; Behavioral: Pilot Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Danzo, PhD; Phone Number: 206-987-1786; Email: sdanzo@uw.edu

Study Locations

• United States
  • Washington
    • Centralia, Washington, United States, 98531
      • Recruiting
      • Northwest Pediatrics
      • Contact: Lily Lo, MD; Phone Number: (360) 736-6778; Email: llo@nwpeds.com
    • Mountlake Terrace, Washington, United States, 98043
      • Recruiting
      • Richmond Pediatrics
      • Contact: Melissa Walsh, MD; Phone Number: (206) 546-2421; Email: melissa.walsh@seattlechildrens.org
    • Olympia, Washington, United States, 98506
      • Recruiting
      • Olympia Pediatrics
      • Contact: Janelle Tiegs; Phone Number: (360) 413-8470; Email: JanelleT@olypeds.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Adolescent 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:

• Age 18 years or older
• works in primary care/outpatient healthcare setting

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: Treatment as Usual; Treatment as usual delivered in participating clinics.
Experimental: 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.	Behavioral: Pilot Intervention; This intervention is a suicide prevention intervention that will be adapted from evidence-based suicide prevention interventions including the SAFETY-Acute program. The specific intervention components will be determined from information gathered in this study but the investigators anticipate will include components such as identifying strengths, coping skills, safety planning, lethal means restriction, psychoeducation, motivation building, and care linkage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Intervention Measure	Feasibility of the intervention (includes 4 items scored on a 5 point likert scale with higher scores representing greater feasibility.)	Participant and providers complete approximately 2 weeks after completing intervention
Acceptability of Intervention Measure	Participant rated acceptability of the intervention (includes 4 items scored on a 5 point likert scale with higher scores representing greater acceptability.)	Participant and providers complete approximately 2 weeks after completing intervention
Intervention Appropriateness Measure	Participant rated appropriateness of the intervention (includes 4 items scored on a 5 point likert scale with higher scores representing greater appropriateness.)	Participant and providers complete approximately 2 weeks after completing intervention
Client Satisfaction Questionnaire	Participant rated satisfaction with the intervention (includes 8 items scored on a 4 point likert scale with higher scores representing greater satisfaction.)	Participant completes approximately 2 weeks after completing intervention
Intervention Usability Scale	Participant rated intervention usability (includes 10 items scored on a 5 point likert scale with greater total score representing greater usability).	Provider completes approximately 2 weeks after completing intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent Self Efficacy Scale	Caregiver rated self-efficacy of being able to keep youth safe (includes 5 items scored on a 5 point likert scale with greater total score representing greater parent self-efficacy).	Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention
Adapted General Self-Efficacy Scale	Patient rated self-efficacy of being able to keep self safe (includes 10 items scored on a 4 point likert scale with greater total score representing greater self-efficacy).	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)	Patient and caregiver rated family involvement/relationship quality (includes 19 items scored on a 5 point likert scale with two subscales [closeness and conflict] where higher total score on each subscale represents greater closeness or conflict).	Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ask Suicide Screening Questions (ASQ)	Exploratory suicide and mental health outcomes (includes 5 items scored as yes/no with greater number of yes or a yes on item 5 representing greater suicide risk).	Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention
Revised Children's Anxiety and Depression Scale-25	Exploratory suicide and mental health outcomes (includes 25 items scored on a 4 point likert scale with higher total score representing greater symptom severity).	Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention
Diagnostic and Statistical Manual of Mental Disorders-5 cross cutting assessment	Exploratory suicide and mental health outcomes (includes 25 items scored on a 4 point likert scale with higher scores representing greater symptom severity).	Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Sarah Danzo, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: July 5, 2024
• First Submitted That Met QC Criteria: July 5, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Behavior; Suicide Prevention; Therapeutics
• Other Study ID Numbers: STUDY00019327; 1K23MH134229-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: De-identified data may be made available upon reasonable request, subject to data use agreements, consent, and institutional policies as long as data does not have potential to identify the participant given the sensitive nature of this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No