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Behavioural Intervention

PALOMA for Suicidal Thoughts (PALOMA Trial)

N/A

Recruiting

Led By Sarah Polk, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up monthly for 9 months

Awards & highlights

PALOMA Trial Summary

This trial aims to develop a strategy to help identify and manage suicidal thoughts and behavior in young Latinx individuals, especially those from immigrant families with parents who speak limited English. They plan to involve community health

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial focuses on non-medical interventions involving communication and education rather than drugs or medical procedures, there are no traditional side effects. However, discussing sensitive topics like suicidal ideation may cause emotional discomfort.

PALOMA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ monthly for 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~monthly for 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and monthly for 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Engagement as assessed by number of follow-up visits

Feasibility as assessed by percent of sessions completed

Percent of Participants Screened

+1 more

Secondary outcome measures

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

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

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

+1 more

PALOMA Trial Design

1Treatment groups

Experimental Treatment

Group I: PALOMAExperimental Treatment1 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH

2,787 Previous Clinical Trials

2,689,546 Total Patients Enrolled

1 Trials studying Suicidal Thoughts

240 Patients Enrolled for Suicidal Thoughts

Johns Hopkins UniversityLead Sponsor

2,267 Previous Clinical Trials

14,837,297 Total Patients Enrolled

Sarah Polk, MDPrincipal InvestigatorJohns Hopkins School of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it feasible for me to be a participant in this clinical investigation?

"Individuals aged between 25 and 100 years experiencing suicidal ideation are eligible for participation in this clinical study, which aims to enroll approximately 250 participants."

Answered by AI

Are potential participants currently able to apply for enrollment in this study?

"Affirmative. The details on clinicaltrials.gov indicate that this investigation is currently enrolling participants. Initially released to the public on March 26, 2024, and most recently revised on April 1, 2024, this research project aims to enroll a total of 250 patients at one designated site."

Answered by AI

What is the current number of individuals enrolled in this clinical study?

"Indeed, the details on clinicaltrials.gov indicate that this ongoing medical trial is actively seeking volunteers. The study was initially posted on March 26, 2024, with the most recent update made on April 1, 2024. This research project aims to recruit a total of 250 participants at a single designated location."

Answered by AI

Is there an age limit regarding patient eligibility for this medical study, specifically for individuals under 40 years old?

"Eligible participants for this research must be between 25 and 100 years old. Notably, there are 39 trials catering to individuals below 18 years of age and another 72 directed towards those above the age of 65."

Answered by AI

What are the main goals being pursued in this medical study?

"The primary endpoint of this investigation, to be evaluated monthly for a span of about 9 months, is the Percentage of Participants Screened. Secondary outcomes consist of Parental Self-Efficacy gauged using the Brief Parenting Self-Efficacy Scale (BPSES) Questionnaire; where scores range from 5 to 25 with higher values indicating increased levels of parental self-assurance. Depression will also be assessed through the Patient Health Questionnaire - Adolescent (PHQ-A), whereby each item carries a score based on frequency ratings ranging from "Not at all" to "Nearly every day". A cumulative score equal to or above"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Improving Screening and Follow Up for Suicidal Ideation and Behaviors Among Latinx Youth in Primary Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06229223.