ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 129 for:    Recruiting, Not yet recruiting, Available Studies | "Self-Injurious Behavior"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03709472
Recruitment Status : Recruiting
First Posted : October 17, 2018
Last Update Posted : November 14, 2018
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Victoria Mitrani, University of Miami

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.

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

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Self-Harm

Arm Intervention/treatment
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.
Other Names:
  • Behavioral: Family Therapy
  • Behavioral: Individual Therapy
  • Behavioral: Technology delivered psycho-educational modules

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.
Other Names:
  • Behavioral: Individual Therapy
  • Behavioral: Family Therapy




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participants who identify as either a Hispanic female (Latina) or Hispanic LGBT (male or female).
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria. The adolescent must:

  • be 12 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),
  • self- identify as a Hispanic female or Hispanic LGBT youth (male or female), 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.

Information from the National Library of Medicine

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


Contacts
Contact: Daniel Santisteban, Ph.D. 305 284-9511 dsantist@miami.edu
Contact: Maite Mena, Psy.D. 305 284-8852 mmena@miami.edu

Locations
United States, Florida
Institute for Individual and Family Counseling Recruiting
Coral Gables, Florida, United States, 33146
Contact: Jessica Jaramillo, M.S.    786-496-4049    jaj204@miami.edu   
Contact: Daniel Santisteban, Ph.D.    305 284-9511    dsantist@miami.edu   
Sponsors and Collaborators
University of Miami
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
Principal Investigator: Daniel Santisteban, Ph.D. University of Miami

Responsible Party: Victoria Mitrani, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03709472     History of Changes
Other Study ID Numbers: 20170791
U54MD002266 ( U.S. NIH Grant/Contract )
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Self-Injurious Behavior
Problem Behavior
Behavioral Symptoms