Suicidal IdeationNCT06229223
Improving Screening and Follow Up for Suicidal Ideation and Behaviors Among Latinx Youth in Primary Care
A study testing PALOMA in people with Suicidal Ideation, run by Johns Hopkins University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 10 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- PALOMA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2024to 6 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Suicidal Ideation
- Being tested
- PALOMA
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PALOMABehavioural
Partnering with Parents of Adolescent Latinos on Mental Health Assistance
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: PALOMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Participants Screened
Percent of patients 10-18 years old screened for depression and suicidal ideation and behavior at clinic level
Measured: Monthly for 9 months
Feasibility as assessed by percent of sessions completed
Percent of eligible patients receiving a CHW session
Measured: 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
Measured: 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.
Measured: Monthly for 9 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start26 Mar 2024
- Primary completion6 Jan 2026
- Study completion6 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Sarah Polk, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229223
- Sponsor's protocol ID
- IRB00378575
- Other IDs
- R34MH129771
- Status last verified
- Apr 2026
- First submitted
- 19 Jan 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Screening and Follow Up for Suicidal Ideation and Behaviors Among Latinx Youth in Primary Care
- ClinicalTrials.gov ID
- NCT06229223
- Acronym / sponsor ID
- IRB00378575
- Conditions
- Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 6 Jan 2026 (actual)
- Study completion
- 6 Jan 2026 (actual)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PALOMA | Experimental | Behavioral: PALOMAParents/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. |
Who may qualify
- Ages
- 10 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PALOMAPartnering with Parents of Adolescent Latinos on Mental Health Assistance | Behavioural | PALOMA |
Primary outcome
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
Feasibility as assessed by percent of sessions completed
Time frame: Monthly for 9 months
Percent of eligible patients receiving a CHW session
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
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.
6 secondary outcomes
Family Functioning as assessed by the SCORE-15 Index of Family Functioning and Change (SCORE-15)
Time frame: Baseline and 3 months
Parent Self Efficacy as assessed by Brief Parenting Self Efficacy Scale (BPSES) Questionnaire
Time frame: Baseline and 3 months
Depression as assessed by the Patient Health Questionnaire - Adolescent (PHQ-A)
Time frame: Baseline and 3 months
Suicidal Ideation and Behavior as assessed by the Ask Suicide-Screening Questionnaire (ASQ)
Time frame: Baseline and 3 months
Parental Self-Efficacy to Support Teens During a Suicidal Crisis survey
Time frame: Baseline and 3 months
Parent expectations of adolescents' risk survey
Time frame: Baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Polk, MD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PALOMA in people with Suicidal Ideation, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Participants Screened (time frame: Monthly for 9 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.