Computer Assisted Family Intervention to Treat Self-Harm Disparities in Latinas and Sexual/Gender Minority Youth
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|ClinicalTrials.gov Identifier: NCT03709472|
Recruitment Status : Recruiting
First Posted : October 17, 2018
Last Update Posted : July 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Self Harm Depression Emotion Dysregulation Behavior Problem||Behavioral: Computer Assisted CIFFTA Behavioral: Behavioral: Traditional face-to-face treatment-no technology||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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)|
|Official Title:||Computer Assisted Family Intervention to Treat Self- Harm Disparities in Latinas and Sexual/Gender Minority Youth (CA CIFFTA)|
|Actual Study Start Date :||November 12, 2018|
|Estimated Primary Completion Date :||April 30, 2022|
|Estimated Study Completion Date :||April 30, 2022|
Experimental: Computer Assisted CIFFTA
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. 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
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.
Active Comparator: Behavioral: Traditional face-to-face treatment-no technology
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
Community agencies provide mostly individual counseling but may add some family involvement in treatment planning.
- Change in self harm behavior [ Time Frame: Baseline, 4 months post baseline, 12 months post baseline ]Mean change in suicidal behavior (minimum total score 0, maximum total score 5; higher total scores indicate more suicidal behavior)
- Sexual Minority Adolescent Stress Instrument (SMASI) [ Time Frame: Baseline, 4 months post baseline, 12 months post baseline ]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.
- Family Functioning [ Time Frame: Baseline, 4 months post baseline, 12 months post baseline ]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.
- Emotional Dysregulation [ Time Frame: Baseline, 4 months post baseline, 12 months post baseline ]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).
- Substance Use [ Time Frame: Baseline, 4 months post baseline, 12 months post baseline ]Alcohol and other drug use will be measured by the Youth Risk Behavior Survey questions on substance use.
- Risky Sexual Behavior [ Time Frame: Baseline, 4 months post baseline, 12 months post baseline ]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.
- Severity of depression [ Time Frame: Baseline, 4 months post baseline, 12 months post baseline ]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.
- Self-harm behavior [ Time Frame: Baseline, 4 months post baseline, 12 months post baseline ]Self administered Deliberate Self-harm Inventory Youth Version (DSHI-Y) that measures the frequency of non-suicidal self-injury.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03709472
|Contact: Daniel Santisteban, Ph.D.||305 firstname.lastname@example.org|
|Contact: Maite Mena, Psy.D.||305 email@example.com|
|Principal Investigator:||Daniel Santisteban, Ph.D.||University of Miami|