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

NCT ID: NCT06499740

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-10-01
• Study Completion Date: 2028-03-31

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 an adaptation of 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 adapt and optimize a brief, evidence-based suicide intervention, SAFETY-Acute (SAFETY-A; formerly known as Family Intervention for Suicide Prevention -aka FISP), for use in primary care settings to support primary care management of adolescents with low to moderate risk suicidal thoughts and behaviors (STB). In this trial, the investigators will conduct a pre-post quasi-experimental pilot feasibility and preliminary efficacy trial of an adapted STB model of care based of the SAFETY-Acute intervention, 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 (16 dyads per clinic). The investigators will assess acceptability and feasibility of the STB model of care, preliminary intervention impacts, and need for further adaptation.

Conditions

Suicide Prevention

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type: BEHAVIORAL

Treatment as usual delivered in participating clinics.

SAFETY-A Based Adapted Intervention

Arm 2 entails months 3-4 of this study. Participating providers will deliver the adapted intervention for the second half (months 3-4) of the pilot trial. The intervention will be based on the evidence-based 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 safety planning, lethal means restriction, communication, identifying adolescent and family strengths, and linking to longer term care.

Group Type: EXPERIMENTAL

Adapted SAFETY-A for PC

Intervention Type: BEHAVIORAL

This intervention is a suicide prevention intervention that will be adapted from the evidence-based 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 safety planning, lethal means restriction, psychoeducation, motivation building, and care linkage.

Interventions

Adapted SAFETY-A for PC

This intervention is a suicide prevention intervention that will be adapted from the evidence-based 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 safety planning, lethal means restriction, psychoeducation, motivation building, and care linkage.

Intervention Type: BEHAVIORAL

Treatment as Usual

Treatment as usual delivered in participating clinics.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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 or intent to kill self)

Exclusion Criteria

• high suicide risk (endorses current plan or intent or ASQ score =5, or prior attempt within last 3 months)
• does not speak fluent English

Note: Caregivers of 10-18 yr olds will also be included so age limits for participating samples include:

1. Adolescents: ages 10-18 years old

2. Parents/Caregivers: ages 18 years and older

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Sarah Danzo

Assistant Professor, Department of Psychiatry and Behavioral Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah Danzo, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Central Contacts

Sarah Danzo, PhD

Role: CONTACT

sdanzo@uw.edu

206-987-1786

Other Identifiers

1K23MH134229-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00019327

Identifier Type: -

Identifier Source: org_study_id