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OpenTrials
Completed

NCT Number: NCT06229223

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

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.

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Key information

Age range

10 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BMS at Yard 56

Baltimore, Maryland, 21224, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PALOMA

Behavioral

Partnering with Parents of Adolescent Latinos on Mental Health Assistance

Primary outcomes

  1. Percent of Participants Screened

    Time frame: Monthly for 9 months

    Percent of patients 10-18 years old screened for depression and suicidal ideation and behavior at clinic level

  2. Feasibility as assessed by percent of sessions completed

    Time frame: Monthly for 9 months

    Percent of eligible patients receiving a CHW session

  3. Quality as assessed by percent of CHW visits

    Time frame: Monthly for 9 months

    Percent of CHW visits that include delivery of one or more intervention components

  4. Engagement as assessed by number of follow-up visits

    Time frame: Monthly for 9 months

    number of follow-up mental health visits with PCP or specialty provider among youth identified as having suicidal ideation or behavior.

Secondary outcomes

  1. Family Functioning as assessed by the SCORE-15 Index of Family Functioning and Change (SCORE-15)

    Time frame: Baseline and 3 months

    SCORE-15 Index of Family Functioning and Change: Score range 5-15, higher total means worse functioning.

  2. Parent Self Efficacy as assessed by Brief Parenting Self Efficacy Scale (BPSES) Questionnaire

    Time frame: Baseline and 3 months

    Brief Parenting Self Efficacy Scale (BPSES) Questionnaire: Total score ranges from 5 to 25, higher scores indicate higher levels of parental self-efficacy.

  3. Depression as assessed by the Patient Health Questionnaire - Adolescent (PHQ-A)

    Time frame: Baseline and 3 months

    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.

  4. Suicidal Ideation and Behavior as assessed by the Ask Suicide-Screening Questionnaire (ASQ)

    Time frame: Baseline and 3 months

    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.

  5. Parental Self-Efficacy to Support Teens During a Suicidal Crisis survey

    Time frame: Baseline and 3 months

    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.

  6. Parent expectations of adolescents' risk survey

    Time frame: Baseline and 3 months

    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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2024
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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