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

Not Applicable

Not yet recruiting

• Conditions: Suicide Prevention
• Interventions: Behavioral: Treatment as Usual; Behavioral: Adapted SAFETY-A for PC

• Registration Number: NCT06499740
• Lead Sponsor: University of Washington

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-05
• Study First Submitted QC: 2024-07-05
• Last Update Submitted: 2024-07-11
• Study First Posted: 2024-07-12
• Last Update Posted: 2024-07-15
• Study Start: 2027-08-01
• Primary Completion: 2028-03-31
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment as usual	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.
SAFETY-A Based Adapted Intervention	Adapted SAFETY-A for PC	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.

Primary Outcome Measures

Name	Time	Method
Intervention Appropriateness Measure	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.)
Feasibility of Intervention Measure	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.)
Intervention Usability Scale	Participant/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).
Client Satisfaction Questionnaire	Participant completes approximately 2 weeks after completing intervention	Caregiver participant rated satisfaction with the intervention (includes 8 items scored on a 4 point likert scale with higher scores representing greater satisfaction.)
Acceptability of Intervention Measure	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.)
Youth Satisfaction Questionnaire	Participant completes approximately 2 weeks after completing intervention	Adolescent participant rated satisfaction with the intervention (includes 5 items scored on a 3 point likert scale with higher scores representing greater satisfaction.)

Secondary Outcome Measures

Name	Time	Method
Parent Self Efficacy Scale	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).
Adapted General Self-Efficacy Scale	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).
adapted Child Parent Relationship Scale	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 15 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).