Improving Screening and Follow Up for Suicidal Ideation and Behaviors Among Latinx Youth in Primary Care
2 other identifiers
interventional
76
1 country
1
Brief Summary
The objective of this proposal is to develop and pilot a systems-level strategy in pediatric primary care to enhance identification and management of suicidal ideation and behavior in Latinx youth, particularly those in immigrant families with parents who have limited English proficiency (LEP). The investigators will focus on the use of trained community health workers (CHWs) to increase clinic capacity and quality of suicide risk screening and early intervention, with a focus on safety planning, parent psychoeducation and care coordination. Specific aims are 1: To develop site-specific implementation protocols for the integration of CHWs into SIB screening and safety planning for Latinx youth and the youths families; 2: To pilot the implementation of the program in a six-month open trial in four pediatric primary care practices representing a range of usual practice settings; and 3: To engage a stakeholder network to explore barriers and facilitators, including costs and billing strategies, to implementation of this approach across a broad range of pediatric primary care settings. Parents/guardians of youth who have been referred to and agree to participate in the intervention by the child's primary care provider will participate in a 2-month program consisting of 6-8 phone sessions with a community health worker focusing on safety planning, information/education, program solving and self-care. Research participants will be asked to complete a survey via phone at the beginning of the program and another at the end of the program. The participants may also be asked to participate in an additional interview about the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2024
CompletedFirst Posted
Study publicly available on registry
January 29, 2024
CompletedStudy Start
First participant enrolled
March 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 6, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 6, 2026
CompletedApril 13, 2026
April 1, 2026
1.8 years
January 19, 2024
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Percent of Participants Screened
Percent of patients 10-18 years old screened for depression and suicidal ideation and behavior at clinic level
Monthly for 9 months
Feasibility as assessed by percent of sessions completed
Percent of eligible patients receiving a CHW session
Monthly for 9 months
Quality as assessed by percent of CHW visits
Percent of CHW visits that include delivery of one or more intervention components
Monthly for 9 months
Engagement as assessed by number of follow-up visits
number of follow-up mental health visits with PCP or specialty provider among youth identified as having suicidal ideation or behavior.
Monthly for 9 months
Secondary Outcomes (6)
Family Functioning as assessed by the SCORE-15 Index of Family Functioning and Change (SCORE-15)
Baseline and 3 months
Parent Self Efficacy as assessed by Brief Parenting Self Efficacy Scale (BPSES) Questionnaire
Baseline and 3 months
Depression as assessed by the Patient Health Questionnaire - Adolescent (PHQ-A)
Baseline and 3 months
Suicidal Ideation and Behavior as assessed by the Ask Suicide-Screening Questionnaire (ASQ)
Baseline and 3 months
Parental Self-Efficacy to Support Teens During a Suicidal Crisis survey
Baseline and 3 months
- +1 more secondary outcomes
Study Arms (1)
PALOMA
EXPERIMENTALParents/guardians of youth who have been referred to and agree to participate in the intervention by the child's primary care provider will participate in a 2-month program consisting of 5-7 phone sessions with a community health worker focusing on safety planning, information/education, program solving and self-care. Research participants will be asked to complete a survey via phone at the beginning of the program and another at the end of the program. The participants may also be asked to participate in an additional interview about the participants experience during the study.
Interventions
Eligibility Criteria
You may qualify if:
- Youth has history of suicidal ideation/behavior or non-suicidal self-harm and
- Youth identifies as Latino/Latinx/Hispanic/Latin American and
- Guardian(s) speaks Spanish
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BMS at Yard 56
Baltimore, Maryland, 21224, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah Polk, MD
Johns Hopkins School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2024
First Posted
January 29, 2024
Study Start
March 26, 2024
Primary Completion
January 6, 2026
Study Completion
January 6, 2026
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Data will be made available while safeguarding the privacy of participants, \& protecting confidential \& proprietary data. Investigators will have access to results free from personal identifiers \& PHI. Investigators will fill out a request form that specifies the purpose of the request, the data requested \& the qualifications of the requestor. Final research data will include recorded factual material necessary to document \& support research findings, including final data sets (w/ identifiers redacted), data collection protocols data, \& database documentation. Users must agree to the conditions of use governing access to the publicly released data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, restrictions on use for commercial purposes, \& proper acknowledgement of the data resource.