NCT06229223

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 26, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

January 19, 2024

Last Update Submit

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

EXPERIMENTAL

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

Interventions

PALOMABEHAVIORAL

Partnering with Parents of Adolescent Latinos on Mental Health Assistance

PALOMA

Eligibility Criteria

Age10 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Sarah Polk, MD

    Johns Hopkins School of Medicine

    PRINCIPAL INVESTIGATOR

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.

Locations