Study Summary
This trial will help researchers understand how to better treat self-harm in Latino adolescents, specifically Latinas and sexual/gender minority youth.
Eligible Conditions
- Self-Harm
- Emotional Dysregulation
- Behavioral Problem
- Depression
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: Baseline, 4 months post baseline, 12 months post baseline
Month 12
Change in self harm behavior
Emotional Dysregulation
Family Functioning
Risky Sexual Behavior
Self-harm behavior
Severity of depression
Sexual Minority Adolescent Stress Instrument (SMASI)
Substance Use
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Behavioral: Traditional face-to-face treatment-no technology
1 of 2
Computer Assisted CIFFTA
1 of 2
Active Control
Experimental Treatment
100 Total Participants · 2 Treatment Groups
Primary Treatment: Computer Assisted CIFFTA · No Placebo Group · N/A
Computer Assisted CIFFTA
Behavioral
Experimental Group · 1 Intervention: Computer Assisted CIFFTA · Intervention Types: BehavioralBehavioral: Traditional face-to-face treatment-no technology
Behavioral
ActiveComparator Group · 1 Intervention: Behavioral: Traditional face-to-face treatment-no technology · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 4 months post baseline, 12 months post baseline
Who is running the clinical trial?
National Institute on Minority Health and Health Disparities (NIMHD)NIH
288 Previous Clinical Trials
706,066 Total Patients Enrolled
University of MiamiLead Sponsor
794 Previous Clinical Trials
384,823 Total Patients Enrolled
Daniel Santisteban, Ph.D.Principal InvestigatorUniversity of Miami
Eligibility Criteria
Age 11 - 18 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:report an act of self-harm that they have done in the past 6 months.
met criteria for cutoff on two of the four underlying/maintaining factors (depression, emotion dysregulation, family conflict, substance use).
People who take part in the study should live with at least one parent-figure who agrees to participate in assessments and treatment, be willing and able to participate fully in the protocol, and allow their treatment sessions to be recorded for fidelity/process assessment and supervision.
References
- Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Interventions for self-harm in children and adolescents. Cochrane Database Syst Rev. 2021 Mar 7;3:CD013667. doi: 10.1002/14651858.CD013667.pub2.
- Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Interventions for self-harm in children and adolescents. Cochrane Database Syst Rev. 2021 Mar 7;3(3):CD013667. doi: 10.1002/14651858.CD013667.pub2.
- Victoria Mitrani 2018. "Computer Assisted Family Intervention to Treat Self-Harm Disparities in Latinas and Sexual/Gender Minority Youth". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03709472.
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Conditions
Cancer Related
Treatments