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

Study Overview
=================
Brief 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.

Detailed 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.

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

Conditions
-----------------
Self Harm, Depression, Emotion Dysregulation, Behavior Problem

Intervention / Treatment
-----------------
* Behavioral: Computer Assisted CIFFTA
* Behavioral: Behavioral: Traditional face-to-face treatment-no technology


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization will be stratified by gender, type of self-harm, trauma exposure and LGBT status. The investigators will attempt to match overall contact hours (in the experimental condition some of these hours will be with technology). During the continuing care phase the CIFFTA families will interact with the therapist via the website for a period of 8 additional weeks. To match dosage time during aftercare, Treatment As Usual (TAU) will receive check-in telephone calls with the therapist.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computer Assisted CIFFTA<br>CA CIFFTA (Computer Assisted Culturally Informed and Flexible Family Based Treatment for Adolescents) consists of a hybrid intervention utilizing office-based CIFFTA and technology-delivered material. Over 16 weeks CIFFTA participants receive 45 minutes of face-to-face sessions plus approximately 45 minutes of web-based intervention per week. During the continuing care phase participants access website resources and receive targeted messages (e.g., handling family conflicts). CA CIFFTA will: 1) deliver psycho-educational modules (e.g., depression, emotion regulation), 2) collect diary-card information, and 3) provide additional resources. During videos parents and adolescents can report symptoms and information that is automatically transmitted to therapists and used in the next session | Behavioral: Computer Assisted CIFFTA<br>* 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.<br>* Other names: Behavioral: Technology delivered psycho-educational modules;|
| Active Comparator: Behavioral: Traditional face-to-face treatment-no technology<br>Participants randomized to Treatment-As-Usual (TAU) work over a 16-week period with their community agency. They may receive individual or family treatment. The team coordinates with the TAU agencies to minimize the overlap of data collected. The team will refer out to service locations that are most convenient for the participant. A great deal of thought has gone into the selection of the Treatment as Usual condition. The investigators wanted to compare CA CIFFTA's ability to retain and bring about change in participants with what is typically done in the community. Although running an in-house comparison condition gives more control of the delivery of services and tracking of clients, it is difficult to know how that compared to the services that are typically provided in the community | Behavioral: Behavioral: Traditional face-to-face treatment-no technology<br>* Community agencies provide mostly individual counseling but may add some family involvement in treatment planning.<br>* Other names: Behavioral: Family Therapy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |