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NCT Number: NCT06499740

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

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.

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Key information

Conditions

Suicide Prevention Behavior Behavioral Symptoms Self-Injurious Behavior Suicide

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwest Pediatrics, Centralia, Washington, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Treatment as Usual

Behavioral

Treatment as usual delivered in participating clinics.

Primary outcomes

  1. 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.)

  2. 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.)

  3. 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.)

  4. 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.)

  5. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

Other outcomes

  1. 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).

  2. 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).

  3. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Danzo, PhD

CONTACT

[email protected]

206-987-1786

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 12, 2024
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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