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

NCT06499740 | Recruiting DMC

• 2 other identifiers: STUDY000193271K23MH134229-01A1
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

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.

Conditions

Suicide Prevention

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• 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

• 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

Other Outcomes (3)

• Ask Suicide Screening Questions (ASQ)

  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

  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

  Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention

Study Arms (2)

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.

Behavioral: Treatment as Usual

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.

Behavioral: Pilot Intervention

Interventions

Pilot Intervention BEHAVIORAL

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.

Pilot Intervention

Treatment as Usual BEHAVIORAL

Treatment as usual delivered in participating clinics.

Treatment as usual

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• high suicide risk (endorses current plan and intent)
• does not speak fluent English
• does not have a primary care provider
• Age 18 years or older
• does not speak English
• Age 18 years or older
• works in primary care/outpatient healthcare setting

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

Northwest Pediatrics

Centralia, Washington, 98531, United States

RECRUITING

Richmond Pediatrics

Mountlake Terrace, Washington, 98043, United States

RECRUITING

Olympia Pediatrics

Olympia, Washington, 98506, United States

RECRUITING

MeSH Terms

Conditions

Suicide Prevention

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Sarah Danzo, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Danzo, PhD

CONTACT

206-987-1786; sdanzo@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Psychiatry and Behavioral Sciences

Model Details: It is anticipated that primary care physicians will deliver initial suicide risk screening, and will refer participating patients and their caregivers to an embedded social worker or integrated mental health clinician within the clinic who will deliver either treatment as usual (TAU; months 1 and 2 of the trial) or the pilot intervention (months 3 and 4 of the trial) to patients endorsing low to moderate suicide risk. Patients will only participate in treatment as usual or the pilot intervention. Outcomes will be compared across the TAU and intervention conditions.

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 12, 2024
• Study Start: May 4, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 27, 2026

Record last verified: 2026-05

Locations

US (3)