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Suicide PreventionNCT06619782

Practice Facilitation to Enhance Implementation of a Pediatric Suicide Prevention Pathway

A study testing Practice Facilitation and Training in National Institute of Mental Health Youth Suicide Prevention Pathway in people with Suicide Prevention, run by University of Colorado, Denver at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 to 80 years
Conditions the study is for
Suicide Prevention
What is being tested?
Practice Facilitation and Training in National Institute of Mental Health Youth Suicide Prevention Pathway
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
1 siteUnited States
Study dates
28 Jan 2025to 31 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Department of Psychiatry, University of Colorado School of Medicine

    Aurora, Colorado, 80045

    Natalie Hazemi, MBA, 720-777-7849, natalie.hazemi@childrenscolorado.org

    Vivian Thompson, MPH, 336-430-1662, vivian.thonpson@cuanschutz.edu

    Recruiting

Other trials in United States

About this study

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 .

Read the 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.

Being tested
Practice Facilitation, Training in National Institute of Mental Health Youth Suicide Prevention Pathway
Keywords
suicide prevention, pediatric primary care, practice facilitation
Medical subject headings
Suicide Prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Practice FacilitationOther

    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

  • Training in National Institute of Mental Health Youth Suicide Prevention PathwayOther

    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

Study groups in NCT06619782
Study groupRoleWhat they receive
Practice FacilitationExperimentalPractice facilitation is added to training in the suicide prevention pathway in primary care to provide implementation support for integrating the pathway into routine care
Receives: Other: Practice Facilitation; Other: Training in National Institute of Mental Health Youth Suicide Prevention Pathway
Training OnlyActive comparatorPrimary care practices are trained in the National Institute of Mental Health (NIMH) youth suicide prevention pathway without practice facilitation
Receives: Other: Training in National Institute of Mental Health Youth Suicide Prevention Pathway

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

Secondary outcomes (1)
  1. Services Assessment for Children and Adolescents - Brief form (SACA)

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2024
  2. Study start28 Jan 2025
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The intervention involves training and implementation of the NIMH suicide prevention pathway in pediatric primary care and family medicine practices
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06619782
Sponsor's protocol ID
23-2155
Other IDs
R34MH132832
Status last verified
Apr 2026
First submitted
20 Sep 2024
Last updated
16 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 38356411

Questions about this trial

What is this clinical trial studying?

A study testing Practice Facilitation and Training in National Institute of Mental Health Youth Suicide Prevention Pathway in people with Suicide Prevention, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Natalie Hazemi, MBA (720-777-7849, Natalie.Hazemi@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ask Suicide Screening Questions (time frame: At enrollment (baseline) and 6 months (study completion)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06619782, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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