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

July 14, 2026 updated by: Sarah Danzo, University of Washington
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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:
      • Mountlake Terrace, Washington, United States, 98043
      • Olympia, Washington, United States, 98506
        • Recruiting
        • Olympia Pediatrics
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 recent suicide risk

Adolescent Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.)
Participant and providers complete approximately 2 weeks after completing intervention
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.)
Participant and providers complete approximately 2 weeks after completing intervention
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.)
Participant and providers complete approximately 2 weeks after completing intervention
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.)
Participant completes approximately 2 weeks after completing intervention
Intervention Usability Scale
Time Frame: 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).
Provider completes approximately 2 weeks after completing intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parent Self Efficacy Scale
Time Frame: Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention
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
Time Frame: Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention
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)
Time Frame: Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ask Suicide Screening Questions (ASQ)
Time Frame: Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention
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
Time Frame: Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention
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
Time Frame: Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sarah Danzo, PhD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 4, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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