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

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University of Washington

Status

Begins enrollment in 7 months

Conditions

Suicide Prevention

Treatments

Behavioral: Adapted SAFETY-A for PC
Behavioral: Treatment as Usual

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06499740
STUDY00019327
1K23MH134229-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 estimated patients

Sex

All

Ages

10+ years old

Volunteers

No Healthy Volunteers

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)

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

48 participants in 2 patient groups

Treatment as usual
Active Comparator group
Description:
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.
Treatment:
Behavioral: Treatment as Usual
SAFETY-A Based Adapted Intervention
Experimental group
Description:
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.
Treatment:
Behavioral: Adapted SAFETY-A for PC

Trial contacts and locations

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Central trial contact

Sarah Danzo, PhD

Data sourced from clinicaltrials.gov

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