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Recruiting NCT06499740

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

No phase Interventional Suicide Prevention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pilot Intervention, Treatment as Usual.
Who it may be relevant to
Registry conditions: Suicide Prevention. Basic parameters: from 10 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • 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.
  • Behavioral Treatment as Usual
    Treatment as usual delivered in participating clinics.

Primary outcome measures

  • Feasibility of Intervention Measure [Time frame: 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]
  • Intervention Appropriateness Measure [Time frame: Participant and providers complete approximately 2 weeks after completing intervention]
  • Client Satisfaction Questionnaire [Time frame: Participant completes approximately 2 weeks after completing intervention]
  • Intervention Usability Scale [Time frame: Provider completes approximately 2 weeks after completing intervention]
Secondary outcome measures (3)
  • Parent Self Efficacy Scale [Time frame: 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]
  • 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]

Eligibility 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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 3 centers
  • Northwest Pediatrics — Centralia
  • Richmond Pediatrics — Mountlake Terrace
  • Olympia Pediatrics — Olympia

Identifiers

NCT: NCT06499740 · STUDY00019327 · 1K23MH134229-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗