Practice Facilitation to Enhance Implementation of a Pediatric Suicide Prevention Pathway

April 15, 2026 updated by: University of Colorado, Denver

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 .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Suicide is a leading cause of death in youth across the United States. Approximately 80% of youth who die by suicide interface with the medical system in the year preceding their death. Primary care practices (PCPs) serving youth are well positioned to detect patients at risk for suicide and intervene, and widely accessible toolkits are available for practices to use. However, effective ways to impact providers' skills in actually carrying out a clinical pathway to manage at-risk patients remain under researched. Indeed, training without applied practice and support is likely not enough to significantly have an effect on these skills in the long term and less likely to improve patient outcomes. Practice facilitation is a powerful way to transform clinical practice, develop provider skills, and improve patient outcomes. The investigators train PCPs in the National Institute of Mental Health (NIMH) youth suicide prevention care pathway and, in addition, assists them in integrating the pathway into routine care with feedback and support through practice facilitation and data collection. However, there is limited evidence for the effects of supports, such as practice facilitation or coaching, on primary care providers' use of and skills in suicide risk assessment and management. Thus, guided by the combined Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM)/Practical Robust Implementation and Sustainability (PRISM) framework, this study will compare the impact of practice facilitation added to suicide prevention training based on the NIMH youth suicide prevention care pathway (TO+PF) versus training only (TO). In this study, Pediatric and Family Medicine practices in collaborating practice-based research networks will be assigned to TO+PF or to TO. Providers in TO+PF clinics will receive practice facilitation for 6 months, involving monthly individual check-ins which include: 1) clinic- and provider-level data review of use data for the five components of the NIMH youth suicide prevention care pathway, 2) clinical coaching around implementing the different components of the pathway, and 3) coaching in identifying barriers to use and strategies to overcome them. At the clinic/provider level, the feasibility, acceptability, effectiveness, adoption, fidelity, use and barriers will be measured. At the patient level, youth assessed at intermediate or high risk and their family will be followed for 6 months following, with data collected on attempted suicides and suicide ideation as well as emergency room and behavioral health provider visits. The outcomes will provide preliminary support for a subsequent larger. study of the suicide prevention pathway, assessing its use, impact, and sustainability, with the goal of promoting broad use in a variety of clinic contexts.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

Youth

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Practice Facilitation
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
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
Other: Training in National Institute of Mental Health Youth Suicide Prevention Pathway
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
Active Comparator: Training Only
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ask Suicide Screening Questions
Time Frame: At enrollment (baseline) and 6 months (study completion)
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
Time Frame: At enrollment (baseline) and 6 months (study completion)
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
Time Frame: At enrollment (baseline) and 6 months (study completion)
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)
Time Frame: At enrollment (baseline) and 6 months (study completion)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Services Assessment for Children and Adolescents - Brief form (SACA)
Time Frame: At enrollment (baseline) and 6 months (study completion)
The Services Assessment for Children and Adolescents (SACA)-Brief Form gathers data on a child's lifetime and past-year use of 30 service settings, 1 item per setting) that are grouped into four broad areas: inpatient, outpatient, school and other (e.g., mentoring, parent aide, supported work). Response options are Yes, No and Don't Know. Administration time is less than 3 minutes. Higher scores indicate more use of services. Kappa statistics indicated acceptable test-retest reliability.
At enrollment (baseline) and 6 months (study completion)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Feasibility of Intervention Measure (FIM)
Time Frame: At enrollment (baseline) and 6 months following enrollment
The The Feasibility of Intervention Measure (FIM) is a 4-item instrument measuring the feasibility on a 5 point scale (Completely Disagree, Disagree, Neither Agree or Disagree, Agree, Completely Agree) of an intervention completed by providers of the intervention. Scores can range from 0-25. A higher mean score indicates higher agreement that intervention is feasible.
At enrollment (baseline) and 6 months following enrollment
Acceptability of Intervention Measure (AIM)
Time Frame: At enrollment (baseline) and 6 months following enrollment
The Acceptability of Intervention Measure (AIM) is 4-item scale that measures the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, and/or satisfactory. Ratings are made on 5-point scale (Completely Disagree, Disagree, Neither Agree or Disagree, Agree, Completely Agree) of an intervention completed by providers of the intervention. Scores can range from 0-25. A higher mean score indicates higher agreement that intervention is feasible.
At enrollment (baseline) and 6 months following enrollment
Intervention Appropriateness Measure (IAM)
Time Frame: At enrollment (baseline) and 6 months following enrollment
The Intervention Appropriateness Measure (IAM) is 4-item scale that measures the perceived fit, relevance, or compatibility of the innovation or evidence-based practice for a given practice setting, provider, or consumer. Ratings are made on 5-point scale (Completely Disagree, Disagree, Neither Agree or Disagree, Agree, Completely Agree) of an intervention completed by providers of the intervention. Scores can range from 0-25. A higher mean score indicates higher agreement that intervention is appropriate (goodness of fit, suitability, applicability, goodness of match).
At enrollment (baseline) and 6 months following enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bruno J Anthony, PhD, University of Colorado School of Medicine - Anschutz Medical Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 28, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23-2155
  • R34MH132832 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will use a dissemination approach to comply with NIH Policy on dissemination of NIH-Funded Clinical Trial Information and to ensure study findings are available to the research and clinical community as well as the general public. Investigators will ensure that clinical trials under the award are registered and results information is submitted to ClinicalTrials.gov as outlined in the NIH Policy on the Dissemination of Clinical Trial Information and according to the specific timelines stated in the Policy. Registration will occur prior to IRB approval but no later than 21 days following enrollment of the first subject. Once a study record is established, required updates will be performed at least once every 12 months,, confirming the completeness and accuracy of the study record. Summary results will be submitted by the standard results submission due date, and any required results updates will be submitted according to ClinicalTrials.gov regulations

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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