Practice Facilitation to Enhance Implementation of a Pediatric Suicide Prevention Pathway

NCT06619782 | Recruiting

• 2 other identifiers: 23-2155R34MH132832
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

Suicide in youth is rapidly growing to where it is the second leading cause of death across the United States. Use of available tools have shown the potential to boost primary care providers' (PCPs) detection of suicide risk and confidence and knowledge around addressing it; however, ways that work to address clinic and provider barriers that influence the ongoing implementation of a pathway to manage at-risk patients remain under researched. The proposed study will assess the impact of the investigators Facilitated Suicide Prevention program--which provides support to assist practices in integrating screening, assessment, data analysis and management procedures into routine care through feedback and coaching--on clinic use of the suicide prevention pathway and youth suicide. The project hypothesizes that compared to PCPs in Training Only (TO) practices, those in TO+Practice Facilitation (PF) may rate the care pathway as more able to be carried out and acceptable; demonstrate greater use of the pathway components (screening, risk assessment, safety planning, lethal means safety counseling, referrals and follow-up); demonstrate higher levels of use of the pathway suicide prevention skills ; and report higher levels of confidence putting the care pathway into use. Also we predict that, compared to youth who screen positive for suicide risk and are followed by PCPs in TO practices, those who screen positive and are followed by PCPs in TO+PF practices will be less likely to attempt suicide during the next six months; less likely to have suicidal ideation during the next 6 months; more likely to see a behavioral health provider during the next 6 months; and less likely to be sent to Emergency Departments during the next 6 months .

Conditions

Suicide Prevention

Keywords

suicide prevention; pediatric primary care; practice facilitation

Outcome Measures

Primary Outcomes (4)

• Ask Suicide Screening Questions

  A set of four brief suicide screening questions that takes 20 seconds to administer. A validated tool that is approved for use by the Joint Commission for all ages

  At enrollment (baseline) and 6 months (study completion)

• Suicidal Ideation Questionnaire

  The Suicidal Ideation Questionnaire (SIQ) assesses the frequency of suicidal ideation.The SIQ consists of 30 items and is appropriate for students in Grades 10-12. The Suicidal Ideation Questionnaire-Junior (SIQ-JR) consists of 15 items and is designed for students in Grades 7-9, consists of a subset of items from the original SIQ. For both the SIQ and SIQ-Jr, the stem indicates "Listed below are a number of sentences about thoughts that people sometimes have. Each item has 7 response options ranging from 0 ("I never had this thought") to 6 ("almost every day"). Scoring is done by summing the item response scores for a range of 0 to 180 for the SIQ and 0 to 90 for the SIQ-JR, with higher scores indicating the presence of more symptomatology.

  At enrollment (baseline) and 6 months (study completion)

• Patient Health Questionnaire-9

  A 9- item measure that assesses the severity of depressive disorders and episodes (or clinically significant symptoms of depressive disorders and episodes) in children ages 11-17. It was adapted from Patient Health Questionnaire-9 modified for Adolescents (PHQ-A\]). Possible range of scores is 0 to 27, with the higher scores indicating the presence of more symptomatology. Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.

  At enrollment (baseline) and 6 months (study completion)

• Center for Epidemiological Studies Depression Scale (CES-D)

  Center for Epidemiological Studies Depression Scale (CES-D) is a 20-item self-report scale that measures the severity of depression symptoms over the past week. The scale can be used by individuals between the ages of 6 to 17. Possible range of scores is 0 to 60, with the higher scores indicating the presence of more symptomatology.

  At enrollment (baseline) and 6 months (study completion)

Secondary Outcomes (1)

• Services Assessment for Children and Adolescents - Brief form (SACA)

  At enrollment (baseline) and 6 months (study completion)

Other Outcomes (3)

• Feasibility of Intervention Measure (FIM)

  At enrollment (baseline) and 6 months following enrollment

• Acceptability of Intervention Measure (AIM)

  At enrollment (baseline) and 6 months following enrollment

• Intervention Appropriateness Measure (IAM)

  At enrollment (baseline) and 6 months following enrollment

Study Arms (2)

Practice Facilitation

EXPERIMENTAL

Practice facilitation is added to training in the suicide prevention pathway in primary care to provide implementation support for integrating the pathway into routine care

Other: Practice Facilitation; Other: Training in National Institute of Mental Health Youth Suicide Prevention Pathway

Training Only

ACTIVE COMPARATOR

Primary care practices are trained in the National Institute of Mental Health (NIMH) youth suicide prevention pathway without practice facilitation

Other: Training in National Institute of Mental Health Youth Suicide Prevention Pathway

Interventions

Practice Facilitation OTHER

Practice facilitation (PF) is a supplemental support to increase competence and and adoption of the National Institute of Mental Health (NIMH) youth suicide prevention. pathway in primary care. Practices will receive 6 months of PF which involves clinic- and provider- level data review and adoption data for the 5 components of the prevention pathway, clinical coaching around implementing the different components , logistical coaching in identifying multilevel contextual barriers to implementation and strategies to overcome them

Practice Facilitation

Training in National Institute of Mental Health Youth Suicide Prevention Pathway OTHER

Training in the National Institute of Mental Health (NIMH) Youth Suicide Prevention Pathway involves a 2-hour in-person presentation created in consultation with NIMH, Zero Suicide and Substance Abuse and Mental Health Services Administration. It is delivered by a licensed professional counselor with content expertise to all primary care practice personnel involved in the prevention pathway. The first hour focuses on conducting Ask Suicide Screening Questions (ASQ) screening, identifying risk/protective factors, identifying warning signs and conducting a brief suicide safety assessment. The second hour covers safety planning, lethal means safety, behavioral health referrals and arranging follow-up. Didactic and interactive methods are used, including group discussion, activities, videos and case vignettes

Practice Facilitation; Training Only

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Youth
• between the ages of 12 and 24 years
• present to a participating PCP and practice for a well visit
• receive a positive ASQ screen during their well visit. Providers
• All staff in enrolled Primary Care practices (e.g., physicians, physician assistants nurses, administrative staff) will be eligible to participate and complete relevant measures.

You may not qualify if:

• Youth
• Over 24 years
• Do not receive a positive ASQ screen at well visit.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Department of Psychiatry, University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

RECRUITING

Related Publications (1)

• Pitts BH, Doyle R, Wood L, Dar R, De Jesus Ayala S, Sharma T, St Pierre M, Anthony B. Brief Interventions for Suicidal Youths in Medical Settings: A Meta-Analysis. Pediatrics. 2024 Mar 1;153(3):e2023061881. doi: 10.1542/peds.2023-061881.

  PMID: 38356411 BACKGROUND

Related Links

• Site provides access to descriptions of study and relevant background information

MeSH Terms

Conditions

Suicide Prevention

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Bruno J Anthony, PhD

  University of Colorado School of Medicine - Anschutz Medical Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalie Hazemi, MBA

CONTACT

720-777-7849; Natalie.Hazemi@childrenscolorado.org

Vivian Thompson, MPH

CONTACT

336-430-1662; vivian.thompson@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention involves training and implementation of the NIMH suicide prevention pathway in pediatric primary care and family medicine practices

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: October 1, 2024
• Study Start: January 28, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The research resources and data generated from this grant will be freely distributed, as available, to qualified academic investigators for noncommercial research. The data listed above will be uploaded every six months following the onset of data collection (expected date: 3/1/25) to the National Database for Clinical Trials related to Mental Illness after being harmonized to its Data Dictionary. The IDP information (Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report and Analytic Code) will be available 3 months following publication of seminal article of results and ending 5 years following publication.
• Access Criteria: Researchers who provide a methodologically sound proposal will have access to the Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report and Analytic Code. Data will be available through the National Database for Clinical Trials. Requests should be sent to Dr. Bruno Anthony (PI) at bruno.anthony@cuanschutz.edu. Data requestors will need to sign a Data Use Agreement.

Locations

US (1)