Clinical trial NCT06499740: Adapting a Brief Suicide Intervention for Pediatric Primary Care: Enhancing Uptake and Impact
Official title: Adapting a Brief Suicide Intervention for Pediatric Primary Care: Enhancing Uptake and Impact
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Suicide Prevention
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-07-12
Enrollment: 48
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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 low to moderate suicide risk.

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

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Intervention Measure
timeFrame: Participant and providers complete approximately 2 weeks after completing intervention
measure: Acceptability of Intervention Measure
timeFrame: Participant and providers complete approximately 2 weeks after completing intervention
measure: Intervention Appropriateness Measure
timeFrame: Participant and providers complete approximately 2 weeks after completing intervention
measure: Client Satisfaction Questionnaire
timeFrame: Participant completes approximately 2 weeks after completing intervention
measure: Youth Satisfaction Questionnaire
timeFrame: Participant completes approximately 2 weeks after completing intervention
measure: Intervention Usability Scale
timeFrame: Participant/provider completes approximately 2 weeks after completing intervention
Secondary outcomes:
measure: Parent Self Efficacy Scale
timeFrame: Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention
measure: Adapted General Self-Efficacy Scale
timeFrame: Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention
measure: adapted Child Parent Relationship Scale
timeFrame: Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention
Other outcomes:
measure: Ask Suicide Screening Questions (ASQ)
timeFrame: Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention
measure: Revised Children's Anxiety and Depression Scale-25
timeFrame: Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention
measure: Diagnostic and Statistical Manual of Mental Disorders-5 cross cutting assessment
timeFrame: Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention
Locations:
Study officials:
affiliation: University of Washington
name: Sarah Danzo, PhD
role: PRINCIPAL_INVESTIGATOR
References: