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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03709472
• Other study ID #: 20170791
• Secondary ID: U54MD002266
• Status: Completed
• Phase: N/A
• Start date: November 12, 2018
• Est. completion date: August 23, 2023

Study information

• Verified date: August 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study enhances an original Computer Assisted Culturally Informed and Flexible Family-Based Treatment for Adolescents (CA CIFFTA) to directly address key targets related to self-harm behavior (e.g., depression, emotion dysregulation, LGBT, culture-related stressors, and trauma-related stressors); (b) refines the technological aspects of CA CIFFTA for web-based delivery; and (c) tests the preliminary efficacy of the new intervention and its delivery system in a randomized trial of 100 Hispanic adolescents and their parents. The investigators seek to reduce risk for repeated self-harm by showing treatment effects on depression, emotion regulation, substance use, and family functioning. Participants are randomly assigned to CA CIFFTA or Treatment-As-Usual and treatment covers a four month period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: August 23, 2023
• Est. primary completion date: August 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Behavior Problem
• Depression
• Emotion Dysregulation
• Problem Behavior
• Self Harm
• Self-Injurious Behavior

Intervention

Behavioral:
• Computer Assisted CIFFTA
This is a hybrid intervention that includes individual work with the adolescent (e.g., Motivational Interviewing, diary card identification of triggers), computer assisted psychoeducational work, and intensive family therapy interventions.
• Behavioral: Traditional face-to-face treatment-no technology
Community agencies provide mostly individual counseling but may add some family involvement in treatment planning.

Locations

Country	Name	City	State
United States	Institute for Individual and Family Counseling	Coral Gables	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in self harm behavior	Mean change in suicidal behavior (minimum total score 0, maximum total score 5; higher total scores indicate more suicidal behavior)	Baseline, 4 months post baseline, 12 months post baseline
Secondary	Sexual Minority Adolescent Stress Instrument (SMASI)	LGBTQ-related stressors are measured using 54 items scored as either 0 (NO) or 1 (YES). Scores can range from 0 - 54 with a higher number representing higher stress.	Baseline, 4 months post baseline, 12 months post baseline
Secondary	Family Functioning	Using the Family Environment Scale (FES) we will measure conflict and cohesion in family functioning. The Cohesion subscale measures how well the family gets along. It is scored from 0 -9 (9 items scored 0 or 1) with a score of 9 reflecting better cohesion and relationships. The Conflict subscale measures conflict in the family. It is score from 0 - 9 with a score of 9 reflecting a high degree of conflict.	Baseline, 4 months post baseline, 12 months post baseline
Secondary	Emotional Dysregulation	Difficulties with Emotion Regulation Scale -Short form (DERS), is designed to assess emotional dysregulation using a 5-point Likert Scale. The total score is calculated from the sum of all items, with higher scores indicating greater problems with emotion regulation (Total possible range: 36-180).	Baseline, 4 months post baseline, 12 months post baseline
Secondary	Substance Use	Alcohol and other drug use will be measured by the Youth Risk Behavior Survey questions on substance use.	Baseline, 4 months post baseline, 12 months post baseline
Secondary	Risky Sexual Behavior	Using the Risky Sexual Behavior Questionnaire and a gated procedure that asks specificity of behaviors only to youth who are active, we will ask about sexual behavior, protection, and risky contexts.There are no subscale scores, only individual items reporting frequency of sexual contact, risky sexual contact, unprotected contact. Higher scores equal more frequency of events.	Baseline, 4 months post baseline, 12 months post baseline
Secondary	Severity of depression	As measured by the PHQ-9. The PHQ-9 incorporates the DSM-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. Depression Severity: 0 - none, 1-4 minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.	Baseline, 4 months post baseline, 12 months post baseline
Secondary	Self-harm behavior	Self administered Deliberate Self-harm Inventory Youth Version (DSHI-Y) that measures the frequency of non-suicidal self-injury.	Baseline, 4 months post baseline, 12 months post baseline