N/A
N=168
Computer Assisted Family Intervention to Treat Self-Harm Disparities in Latinas and Sexual/Gender Minority Youth
Self Harm · Depression · Emotion Dysregulation · Suicidal Ideation · Family Relations
Bottom Line
View on ClinicalTrials.gov: NCT03709472 ↗Enrolled (actual)
168
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Columbia Suicide Severity Rating Scale (CSSRS) Suicide Ideation — 20; 13; 16; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Computer Assisted CIFFTA (Behavioral); Behavioral: Traditional face-to-face treatment-no technology (Behavioral)
- Age
- Pediatric, Adult · 11+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Columbia Suicide Severity Rating Scale (CSSRS) Suicide Ideation |
20; 13; 16; 8; 6; 4 | — |
| SECONDARY Number of Participants Who Reported Self-harm Behavior |
25; 18; 14; 11; 4; 4 | — |
| SECONDARY Emotional Dysregulation Measured by Emotion Regulation Scale -Short Form (DERS) |
3.1; 3.2; 2.8; 2.9; 2.6; 2.8 | — |
| SECONDARY The Patient Health Questionnaire |
13.9; 14.9; 10.8; 11.6; 8.9; 10.9 | — |
| SECONDARY Family Connectedness |
32.1; 28.4; 33.4; 31.4; 32.1; 30.2 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03709472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.