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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06499740
Enrollment
48
Registered
2024-07-12
Start date
2026-05-04
Completion date
2028-03-01
Last updated
2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicide Prevention

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 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.

Interventions

BEHAVIORALPilot 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.

BEHAVIORALTreatment as Usual

Treatment as usual delivered in participating clinics.

Sponsors

University of Washington
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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 suicide risk. Patients will only participate in treatment as usual or the pilot intervention. Outcomes will be compared across the TAU and intervention conditions.

Eligibility

Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of Intervention MeasureParticipant and providers complete approximately 2 weeks after completing interventionFeasibility of the intervention (includes 4 items scored on a 5 point likert scale with higher scores representing greater feasibility.)
Acceptability of Intervention MeasureParticipant and providers complete approximately 2 weeks after completing interventionParticipant rated acceptability of the intervention (includes 4 items scored on a 5 point likert scale with higher scores representing greater acceptability.)
Intervention Appropriateness MeasureParticipant and providers complete approximately 2 weeks after completing interventionParticipant rated appropriateness of the intervention (includes 4 items scored on a 5 point likert scale with higher scores representing greater appropriateness.)
Client Satisfaction QuestionnaireParticipant completes approximately 2 weeks after completing interventionParticipant rated satisfaction with the intervention (includes 8 items scored on a 4 point likert scale with higher scores representing greater satisfaction.)
Intervention Usability ScaleProvider completes approximately 2 weeks after completing interventionParticipant rated intervention usability (includes 10 items scored on a 5 point likert scale with greater total score representing greater usability).

Secondary

MeasureTime frameDescription
Parent Self Efficacy ScaleParticipant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the interventionCaregiver 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).
Adapted General Self-Efficacy ScaleParticipant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the interventionPatient 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).
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 interventionPatient 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).

Countries

United States

Contacts

CONTACTSarah Danzo, PhD
sdanzo@uw.edu206-987-1786
PRINCIPAL_INVESTIGATORSarah Danzo, PhD

University of Washington

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026