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

NCT03709472 | Completed Results

• 2 other identifiers: 20170791U54MD002266
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Self Harm; Depression; Emotion Dysregulation; Suicidal Ideation; Family Relations

Outcome Measures

Primary Outcomes (1)

• Columbia Suicide Severity Rating Scale (CSSRS) Suicide Ideation

  The Columbia yields information on suicide ideation and Ideation with Intent. Youth were categorized as having or not having ideation and having or not having intent to suicide (yes/no). Endorsing any of these items as "yes" is a worse outcome. The number listed below is the number of participants that said "yes" to experiencing suicidal ideation in the last month.

  Baseline, 4 months post baseline, 12 months post baseline

Secondary Outcomes (4)

• Number of Participants Who Reported Self-harm Behavior

  Baseline, 4 months post baseline, 12 months post baseline

• Emotional Dysregulation Measured by Emotion Regulation Scale -Short Form (DERS)

  Baseline, 4 months post baseline, 12 months post baseline

• The Patient Health Questionnaire

  Baseline, 4 months post baseline, 12 months post baseline

• Family Connectedness

  Baseline, 4 months post baseline, 12 months post baseline

Study Arms (2)

Computer Assisted CIFFTA

EXPERIMENTAL

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

Behavioral: Traditional face-to-face treatment-no technology

ACTIVE COMPARATOR

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

Interventions

Computer Assisted CIFFTA BEHAVIORAL

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.

Also known as: Behavioral: Family Therapy, Behavioral: Individual Therapy, Behavioral: Technology delivered psycho-educational modules

Computer Assisted CIFFTA

Behavioral: Traditional face-to-face treatment-no technology BEHAVIORAL

Community agencies provide mostly individual counseling but may add some family involvement in treatment planning.

Also known as: Behavioral: Individual Therapy, Behavioral: Family Therapy

Behavioral: Traditional face-to-face treatment-no technology

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Institute for Individual and Family Counseling

Coral Gables, Florida, 33146, United States

Location

Related Publications (1)

• Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Interventions for self-harm in children and adolescents. Cochrane Database Syst Rev. 2021 Mar 7;3(3):CD013667. doi: 10.1002/14651858.CD013667.pub2.

  PMID: 33677832 DERIVED

MeSH Terms

Conditions

Self-Injurious Behavior; Depression; Suicidal Ideation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Suicide

Limitations and Caveats

The COVID disruptions reduced our overall sample size. A limitation is that we did not collect dosage data on treatment received by TAU participants. Finally, with only two timepoints and a small sample, it was impossible to analyze mediation. The best we could do was to explore plausible mediators (Emotion Regulation and Family Connectedness).

Results Point of Contact

• Title: Victoria Mitrani
• Organization: University of Miami

vmitrani@miami.edu

3052849139

Study Officials

• Daniel Santisteban, Ph.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 17, 2018
• Study Start: November 12, 2018
• Primary Completion: August 23, 2023
• Study Completion: August 23, 2023
• Last Updated: November 5, 2024
• Results First Posted: November 5, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)