Children's mental health service use across service sectors.
B J Burns, E J Costello, A Angold...
https://pubmed.ncbi.nlm.nih.gov/7498888Actively Recruiting
Phase Not Applicable
Age: 12Years - 17Years
All Genders
ID06018285
Stepped Approach to Reducing Risk of Suicide in Primary Care
Led by Cynthia Fontanella · Updated on 2025-08-08
2572
Participants Needed
15
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Cynthia Fontanella
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a stepped care approach called STARRS-PC (Stepped Approach to Reducing Risk of Suicide in Primary Care) to reduce suicide risk among youth aged 12 to 17 years receiving primary care. This study aims to compare the effectiveness of STARRS-PC against usual treatment (TAU) in lowering suicide attempts, suicidal thoughts, and self-injury over a 12-month period. The study also explores factors that affect how well the clinical pathway can be put into practice and sustained in primary care settings. The study is conducted over five years at 14 pediatric primary care clinics. It includes three phases: treatment as usual (TAU), intervention, and sustainability. During TAU, usual depression and suicide risk screening is performed. In the intervention phase, STARRS-PC is implemented, which involves universal suicide risk screening with a brief questionnaire, followed by a detailed risk assessment and care decisions based on risk level. Providers receive training and participate in interviews to identify challenges and supports for implementing the clinical care pathway. The final sustainability phase focuses on maintaining improvements without enrolling new participants. Participants include 2,572 adolescents identified at risk for suicide along with their parents or guardians. They complete interviews and questionnaires at baseline, 3, 6, and 12 months. Medical records are reviewed throughout the study. Youth outcomes measured include suicide attempts, suicidal thoughts, and non-suicidal self-injury, while family satisfaction is also assessed. Providers are evaluated on knowledge and attitudes about suicide risk management. The study includes ongoing monitoring, data collection, and a 6-month follow-up after the intervention phase for sustainability analysis.
CONDITIONS
Brief Title
Stepped Approach to Reducing Risk of Suicide in Primary Care
Who Can Participate
Age: 12Years - 17Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 12 to 17 years and their parent/guardian at time of consent
- Identified as being at risk for suicide
- Receiving primary care services at one of 14 participating sites
- Youth recruited regardless of current or past mental health history
- Youth with physical illnesses or receiving medication for physical or psychiatric conditions are eligible if meeting other criteria
- Providers must work with patients at one of the participating pediatric primary care clinics
You will not qualify if you...
- Medically or cognitively unable to participate in study procedures
- Without permanent residence or access to a telephone
- Unable to speak English well enough to understand study procedures
- Providers unable to give consent
- Providers unable to speak English well enough to understand study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Baseline Assessment
Duration - At baseline
Participants complete initial assessments including interviews and questionnaires to establish baseline measures.
1 visit (in-person)
Treatment as Usual (TAU) Phase
Duration - 6 to 26 months
Participants receive usual and customary care with depression and suicide risk screening using PHQ-9, establishing baseline rates of suicide risk detection.
Visits as part of routine primary care
Intervention Phase
Duration - 11 to 30 months
Participants undergo a clinical pathway including universal suicide risk screening with ASQ, risk assessment with BSSA, and tailored clinical care based on risk level.
Multiple visits for suicide risk screening and follow-up assessments at 3, 6, and 12 months post-baseline
Follow-up Assessments
Duration - 12 months post-baseline
Participants complete follow-up assessments at 3, 6, and 12 months after baseline to track outcomes including suicide attempts, suicidal ideation, and family satisfaction.
3 visits (at 3, 6, and 12 months)
Trial Site Locations
Total: 15 locations
1
AxessPointe Community Health Centers/Health Quarters
Akron, Ohio, United States, 44303
Actively Recruiting
2
Signature Health
Ashtabula, Ohio, United States, 44004
Actively Recruiting
3
Holzer Health System
Athens, Ohio, United States, 45701
Actively Recruiting
4
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Not Yet Recruiting
5
Dayton Children's Hospital - Hope Center
Dayton, Ohio, United States, 45404
Actively Recruiting
6
Dayton Children's Hospital - Main
Dayton, Ohio, United States, 45404
Actively Recruiting
7
Holzer Health System
Gallipolis, Ohio, United States, 45613
Actively Recruiting
8
Hilliard Pediatrics
Hilliard, Ohio, United States, 43026
Actively Recruiting
9
Holzer Health System
Jackson, Ohio, United States, 45640
Actively Recruiting
10
Maumee Pediatric Associates
Maumee, Ohio, United States, 43537
Actively Recruiting
11
Cornerstone Pediatrics
Miamisburg, Ohio, United States, 45342
Actively Recruiting
12
Signature Health
Painesville, Ohio, United States, 44077
Actively Recruiting
13
Village Square Primary Care Center
Perrysburg, Ohio, United States, 43551
Not Yet Recruiting
14
Franklin Avenue Primary Care Center
Toledo, Ohio, United States, 43620
Terminated
15
Signature Health
Willoughby, Ohio, United States, 44094
Actively Recruiting
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Research Team
C
Cynthia Fontanella, PhD
P
Priyanka Desirazu, MSE
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Trends in suicide ideation, plans, gestures, and attempts in the United States, 1990-1992 to 2001-2003.
Ronald C Kessler, Patricia Berglund, Guilherme Borges...
https://pubmed.ncbi.nlm.nih.gov/15914749Primary care referral of children with psychosocial problems.
Jerry Rushton, David Bruckman, Kelly Kelleher
https://pubmed.ncbi.nlm.nih.gov/12038893Datapoints: suicide and access to care.
C L Miller, B Druss
https://pubmed.ncbi.nlm.nih.gov/11726741Psychiatric risk factors for adolescent suicide: a case-control study.
D A Brent, J A Perper, G Moritz...
https://pubmed.ncbi.nlm.nih.gov/8496115Psychiatric diagnosis in child and adolescent suicide.
D Shaffer, M S Gould, P Fisher...
https://pubmed.ncbi.nlm.nih.gov/8634012Overview and Methods for the Youth Risk Behavior Surveillance System - United States, 2019.
J Michael Underwood, Nancy Brener, Jemekia Thornton...
https://pubmed.ncbi.nlm.nih.gov/32817611Adolescent suicidal ideation as predictive of psychopathology, suicidal behavior, and compromised functioning at age 30.
Helen Z Reinherz, Jennifer L Tanner, Sasha R Berger...
https://pubmed.ncbi.nlm.nih.gov/16816228Adult outcomes of childhood and adolescent depression. III. Links with suicidal behaviours.
R Harrington, D Bredenkamp, C Groothues...
https://pubmed.ncbi.nlm.nih.gov/7806612