CompletedNot Applicable

Computer Assisted Family Intervention to Treat Self-Harm Disparities in Latinas and Sexual/Gender Minority Youth

United States172 participantsStarted 2018-11-12

Plain-language summary

This study is designed to refine and test the efficacy of a computer assisted culturally informed and flexible/adaptive intervention for Latino adolescents for whom self-harm behaviors are a health disparity-specifically, Latinas and sexual/gender minority youth.

Who can participate

Age range

11 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria. The adolescent must: * be 11 to 18 years old; * self-report an act of self-harm in the past 6 months, * meet criteria for cut-off on two of the four underlying/maintaining factors (depression, emotion dysregulation, family conflict, substance use), and * live with at least one parent-figure who agrees to participate in assessments and treatment Participants should be willing and able to participate fully in the protocol (e.g., to accept assignment to either condition, to provide sufficient locator information for follow-up, to allow their treatment sessions to be recorded for fidelity/process assessment and supervision). Exclusion Criteria. Youth who: * have a history of DSM V Developmental Disorders, Elective Mutism, Organic Mental Disorders, Schizophrenia, Delusional Disorder, Psychotic Disorder, and Bipolar Affective Disorder. * are actively in crisis and reporting current ideation with a specific plan and with means to complete the plan.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Columbia Suicide Severity Rating Scale (CSSRS) Suicide Ideation

Timeframe: Baseline, 4 months post baseline, 12 months post baseline

Trial details

NCT IDNCT03709472

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-23

Results submitted2024-08-23

View on ClinicalTrials.gov More Self Harm trials

Who can participate

Age range

11 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.