Clinical trial NCT03709472: Computer Assisted Family Intervention to Treat Self-Harm Disparities in Latinas and Sexual/Gender Minority Youth
Official title: Computer Assisted Family Intervention to Treat Self- Harm Disparities in Latinas and Sexual/Gender Minority Youth (CA CIFFTA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self Harm
Depression
Emotion Dysregulation
Suicidal Ideation
Family Relations
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2018-10-17
Enrollment: 172
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Columbia Suicide Severity Rating Scale (CSSRS) Suicide Ideation
timeFrame: Baseline, 4 months post baseline, 12 months post baseline
Secondary outcomes:
measure: Number of Participants Who Reported Self-harm Behavior
timeFrame: Baseline, 4 months post baseline, 12 months post baseline
measure: Emotional Dysregulation Measured by Emotion Regulation Scale -Short Form (DERS)
timeFrame: Baseline, 4 months post baseline, 12 months post baseline
measure: The Patient Health Questionnaire
timeFrame: Baseline, 4 months post baseline, 12 months post baseline
measure: Family Connectedness
timeFrame: Baseline, 4 months post baseline, 12 months post baseline
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Institute for Individual and Family Counseling
state: Florida
Study officials:
affiliation: University of Miami
name: Daniel Santisteban, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.