RECRUITING

Stepped Approach to Reducing Risk of Suicide in Primary Care

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Suicide is the second leading cause of death among young people aged 12-17 years in the United States, yet many youth at risk for suicide are not identified or go untreated. Stepped care approaches have been shown to be effective at reducing suicide risk in clinical settings, including primary care. The goal of this hybrid I stepped wedge effectiveness-implementation study is to test the effectiveness of a population-based quality improvement (QI) intervention, entitled STARRS-PC (Stepped Approach to Reducing Risk of Suicide in Primary Care) compared to treatment as usual (TAU), in reducing the risk of suicidal behavior among youth in the pediatric primary care setting. STARRS-PC implements a clinical pathway for youth at elevated risk for suicide in pediatric primary care clinics. Clinical pathways are tools used by health professionals to guide evidence-informed practice. The STARRS-PC pathway consists of three evidence-based suicide clinical care processes: risk detection, assessment and triage, and, if needed, follow-up transitional care. STARRS-PC is guided by the Practical, Robust Implementation, and Sustainability Model (PRISM), which allows for the study of factors that influence effective implementation of the suicide prevention clinical pathway and is focused on scalability. The main questions the study aims to answer are: * Will STARRS-PC be more effective than TAU at reducing the rate of suicide attempt at 12 months post-baseline (primary outcome)? * Will STARRS-PC be more effective than TAU at reducing suicidal ideation and non-suicidal self-injury, and improving family satisfaction at 12 months post-baseline (secondary outcomes)? * What are the barriers and facilitators of effective implementation and sustainability of STARRS-PC?

Official Title

Stepped Approach to Reducing Risk of Suicide in Primary Care

Quick Facts

Study Start:2023-08-08
Study Completion:2027-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06018285

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.

Ages Eligible for Study:12 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Cynthia Fontanella, PhD
CONTACT
(614) 938-0323
cynthia.fontanella@nationwidechildrens.org
Priyanka Desirazu, MSE
CONTACT
(614) 938-1113
STARRS@nationwidechildrens.org

Principal Investigator

Jeffrey Bridge, PhD
PRINCIPAL_INVESTIGATOR
Abigail Wexner Research Institute at NCH
Alex Kemper, MD, MPH, MS
PRINCIPAL_INVESTIGATOR
Abigail Wexner Research Institute at NCH
Cynthia Fontanella, PhD
STUDY_DIRECTOR
Abigail Wexner Research Institute at NCH

Study Locations (Sites)

AxessPointe Community Health Centers/Arlington
Akron, Ohio, 44333
United States
Signature Health
Ashtabula, Ohio, 44004
United States
Holzer Health System
Athens, Ohio, 45701
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
Eastglen Pediatrics
Columbus, Ohio, 43213
United States
Dayton Children's Hospital - Main
Dayton, Ohio, 45404
United States
Dayton Children's Hospital - NW
Dayton, Ohio, 45404
United States
Holzer Health System
Gallipolis, Ohio, 45613
United States
Hilliard Pediatrics
Hilliard, Ohio, 43026
United States
Spring Valley Primary Care Center
Holland, Ohio, 43528
United States
Holzer Health System
Jackson, Ohio, 45640
United States
Kettering Pediatric and Family Care
Kettering, Ohio, 45429
United States
Cornerstone Pediatrics
Miamisburg, Ohio, 45342
United States
Signature Health
Painesville, Ohio, 44077
United States
Village Square Primary Care Center
Perrysburg, Ohio, 43551
United States
Franklin Avenue Primary Care Center
Toledo, Ohio, 43620
United States
Signature Health
Willoughby, Ohio, 44094
United States

Collaborators and Investigators

Sponsor: Cynthia Fontanella

  • Jeffrey Bridge, PhD, PRINCIPAL_INVESTIGATOR, Abigail Wexner Research Institute at NCH
  • Alex Kemper, MD, MPH, MS, PRINCIPAL_INVESTIGATOR, Abigail Wexner Research Institute at NCH
  • Cynthia Fontanella, PhD, STUDY_DIRECTOR, Abigail Wexner Research Institute at NCH

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 Registration Dates

Study Start Date2023-08-08
Study Completion Date2027-07-31

Study Record Updates

Study Start Date2023-08-08
Study Completion Date2027-07-31

Terms related to this study

Keywords Provided by Researchers

  • Suicide
  • STARRS-PC
  • Adolescent
  • Risk Assessment
  • Triage

Additional Relevant MeSH Terms

  • Suicidal Ideation
  • Suicide, Attempted
  • Suicide Prevention