PALOMA for Suicidal Thoughts in Latinx Youth

(PALOMA Trial)

Overseen By Ellen Molino

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to develop and test a new method to assist Latinx youth in immigrant families experiencing thoughts of suicide or self-harm. The plan uses community health workers to enhance clinics' ability to identify and support these young people and their families through safety planning and education. The trial seeks Latinx youth with a history of suicidal thoughts or self-harm, whose guardians speak Spanish, to join a two-month program involving phone sessions. Participants will complete surveys before and after the program to help researchers assess its impact. As an unphased trial, this study offers participants the chance to contribute to innovative approaches that could significantly improve mental health support for Latinx communities.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this protocol is safe for Latinx youth?

Research has shown that the PALOMA program is being tested for safe use with Latinx youth experiencing suicidal thoughts. As this trial is in its early stages, detailed safety information is limited. However, the program employs trained community health workers who provide support through phone calls. This approach, which emphasizes creating safety plans and offering education, generally carries low risk. The trial is ongoing, and researchers are observing participants' reactions to the program. To date, there have been no major reports of negative effects. The involvement of community health workers indicates that the program is supportive and well-received. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PALOMA program because it offers a community-based approach to addressing suicidal thoughts in Latinx youth, focusing on family involvement and cultural relevance. Unlike typical treatments such as medication or individual therapy, PALOMA engages parents or guardians in a series of phone sessions with a community health worker. These sessions emphasize safety planning, education, problem-solving, and self-care, potentially providing a more holistic and supportive environment. This method aims to strengthen the family unit’s role in the youth's mental health journey, which is an innovative angle that could enhance the effectiveness of traditional treatments.

What evidence suggests that this program is effective for managing suicidal thoughts in Latinx youth?

Research shows that community health workers (CHWs) can help clinics better identify and manage suicidal thoughts in Latinx youth. In this trial, participants will engage in a program involving CHWs to create safety plans and provide crucial support to families. Studies have found that involving CHWs in mental health care improves how clinics check for suicide risk and ensures better follow-up care, which is vital for preventing youth suicide. Early results suggest that these strategies can lower suicidal thoughts and actions in Latinx youth, especially those from immigrant families who face language barriers. This method offers a promising way to support at-risk youth and their families. ^{1 2 3 4 6}

Who Is on the Research Team?

Sarah Polk, MD

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

This trial is for Latinx youth experiencing suicidal thoughts and their parents, particularly in immigrant families with limited English proficiency. Participants must be willing to work with a community health worker and speak either English or Spanish.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Parents/guardians participate in a 2-month program with 6-8 phone sessions focusing on safety planning, information/education, problem solving, and self-care

8 weeks

6-8 phone sessions

Follow-up

Participants are monitored for family functioning, parent self-efficacy, and suicidal ideation and behavior

3 months

What Are the Treatments Tested in This Trial?

Interventions

• PALOMA

Trial Overview The PALOMA program is being tested to improve suicide risk screening and early intervention among Latinx youth in primary care. It involves trained community health workers providing phone sessions focused on safety planning, education, problem-solving, and self-care over two months.

How Is the Trial Designed?

Group I: PALOMA Experimental Treatment 1 Intervention

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.

PALOMA is already approved in United States, European Union for the following indications:

Approved in United States as Ibrance for:

• HR-positive, HER2-negative advanced or metastatic breast cancer

Approved in European Union as Ibrance for:

• HR-positive, HER2-negative locally advanced or metastatic breast cancer

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. withpower.com withpower.com/trial/paloma-for-suicidal-thoughts-in-latinx-youth-607b0

PALOMA for Suicidal Thoughts in Latinx Youth This trial is for Latinx youth experiencing suicidal thoughts and their parents, particularly in immigrant families with limited English proficiency.

2. reporter.nih.gov reporter.nih.gov/search/I_bJWIRR_0Kb3TKRVha0zw/project-details/10813094

Improving screening and follow-up for suicidal ideation and ... ... Latinx youth and their families, reduce suicidal ideation and behavior, and prevent youth suicide. Systems-level approaches to the identification and ...

3. researchgate.net researchgate.net/publication/382446326_Responding_to_Acute_Suicidality_Among_Latinx_Youth_From_Immigrant_Families

Responding to Acute Suicidality Among Latinx Youth From ... Results: Non-Hispanic White and Hispanic young adults have higher rates of suicidal ideation than their non-Hispanic Black counterparts, but ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S221265702400062X

Components of risk communication in mental health and ... The objective of this research is to identify key components for mental health risk communication and suicide prevention strategies tailored to Indigenous ...

5. reporter.nih.gov reporter.nih.gov/search/fqHF5V5JKEOGoclnbc2YRw/project-details/10630203

RePORT ⟩ RePORTER We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.

6. escholarship.org escholarship.org/uc/item/5bk0n141

Psychosocial Predictors of Suicidal Thoughts and ... More Latino adolescents report suicidal thoughts and/or behaviors (STBs) than youths of most other ethnic communities. Yet few studies have examined multiple ...