Improving Screening and Follow Up for Suicidal Ideation and Behaviors Among Latinx Youth in Primary Care (PALOMA)

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.

Study Overview

• Status: Completed
• Conditions: Suicidal Ideation
• Intervention / Treatment: Behavioral: PALOMA

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • BMS at Yard 56

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: PALOMA; 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 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.

Behavioral: PALOMA; Partnering with Parents of Adolescent Latinos on Mental Health Assistance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Family Functioning as assessed by the SCORE-15 Index of Family Functioning and Change (SCORE-15)	SCORE-15 Index of Family Functioning and Change: Score range 5-15, higher total means worse functioning.	Baseline and 3 months
Parent Self Efficacy as assessed by Brief Parenting Self Efficacy Scale (BPSES) Questionnaire	Brief Parenting Self Efficacy Scale (BPSES) Questionnaire: Total score ranges from 5 to 25, higher scores indicate higher levels of parental self-efficacy.	Baseline and 3 months
Depression as assessed by the Patient Health Questionnaire - Adolescent (PHQ-A)	Patient Health Questionnaire - Adolescent (PHQ-A): Each item on the PHQ-A is scored as follows: Not at all = 0 Several Days = 1 More than half the days = 2 Nearly every day = 3. A weighted score of 5 or more means a positive screen for depressive symptoms. A weighted score of 0-4 means a negative screen for depressive symptoms.	Baseline and 3 months
Suicidal Ideation and Behavior as assessed by the Ask Suicide-Screening Questionnaire (ASQ)	Ask Suicide-Screening Questionnaire (ASQ): 4 Yes or No Questions. "Yes" to questions 1 through 4, or refuses to answer is considered a positive screen. "Yes" to question 5 = acute positive screen (imminent risk identified); "No" to question 5 = non-acute positive screen.	Baseline and 3 months
Parental Self-Efficacy to Support Teens During a Suicidal Crisis survey	9 items. Answer choices ranged from 0 (not at all confident) to 10 (completely confident), with an anchor of 5 (somewhat confident); score range 0-90; higher score higher confidence.	Baseline and 3 months
Parent expectations of adolescents' risk survey	3 items. Answer choices ranged from 0 (not at all confident) to 10 (completely confident), with an anchor of 5 (somewhat confident). Score range 0-30; higher score higher confidence.	Baseline and 3 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Sarah Polk, MD, Johns Hopkins School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2024
• Primary Completion (Actual): January 6, 2026
• Study Completion (Actual): January 6, 2026

Study Registration Dates

• First Submitted: January 19, 2024
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Behavior; Suicidal Ideation
• Other Study ID Numbers: IRB00378575; R34MH129771 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No