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

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

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

Research Team

Sarah Polk, MD

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+