Back to resultsComputer Assisted Family Intervention to Treat Self-Harm Disparities in Latinas and Sexual/Gender Minority Youth
Primary Purpose
Self Harm, Depression, Emotion Dysregulation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer Assisted CIFFTA
Behavioral: Traditional face-to-face treatment-no technology
Sponsored by
About this trial
This is an interventional treatment trial for Self Harm
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.
Sites / Locations
- Institute for Individual and Family Counseling
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Computer Assisted CIFFTA
Behavioral: Traditional face-to-face treatment-no technology
Arm Description
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
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
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
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.
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).
Substance Use
Alcohol and other drug use will be measured by the Youth Risk Behavior Survey questions on substance use.
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.
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.
Self-harm behavior
Self administered Deliberate Self-harm Inventory Youth Version (DSHI-Y) that measures the frequency of non-suicidal self-injury.
Full Information
NCT ID
NCT03709472
First Posted
October 5, 2018
Last Updated
August 23, 2023
Sponsor
University of Miami
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
1. Study Identification
Unique Protocol Identification Number
NCT03709472
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 12, 2018 (Actual)
Primary Completion Date
August 23, 2023 (Actual)
Study Completion Date
August 23, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self Harm, Depression, Emotion Dysregulation, Behavior Problem
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Computer Assisted CIFFTA
Arm Type
Experimental
Arm Description
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
Arm Title
Behavioral: Traditional face-to-face treatment-no technology
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Computer Assisted CIFFTA
Other Intervention Name(s)
Behavioral: Family Therapy, Behavioral: Individual Therapy, Behavioral: Technology delivered psycho-educational modules
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral: Traditional face-to-face treatment-no technology
Other Intervention Name(s)
Behavioral: Individual Therapy, Behavioral: Family Therapy
Intervention Description
Community agencies provide mostly individual counseling but may add some family involvement in treatment planning.
Primary Outcome Measure Information:
Title
Change in self harm behavior
Description
Mean change in suicidal behavior (minimum total score 0, maximum total score 5; higher total scores indicate more suicidal behavior)
Time Frame
Baseline, 4 months post baseline, 12 months post baseline
Secondary Outcome Measure Information:
Title
Sexual Minority Adolescent Stress Instrument (SMASI)
Description
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.
Time Frame
Baseline, 4 months post baseline, 12 months post baseline
Title
Family Functioning
Description
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.
Time Frame
Baseline, 4 months post baseline, 12 months post baseline
Title
Emotional Dysregulation
Description
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).
Time Frame
Baseline, 4 months post baseline, 12 months post baseline
Title
Substance Use
Description
Alcohol and other drug use will be measured by the Youth Risk Behavior Survey questions on substance use.
Time Frame
Baseline, 4 months post baseline, 12 months post baseline
Title
Risky Sexual Behavior
Description
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.
Time Frame
Baseline, 4 months post baseline, 12 months post baseline
Title
Severity of depression
Description
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.
Time Frame
Baseline, 4 months post baseline, 12 months post baseline
Title
Self-harm behavior
Description
Self administered Deliberate Self-harm Inventory Youth Version (DSHI-Y) that measures the frequency of non-suicidal self-injury.
Time Frame
Baseline, 4 months post baseline, 12 months post baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Santisteban, Ph.D.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Individual and Family Counseling
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33677832
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.
Results Reference
derived
Learn more about this trial
Computer Assisted Family Intervention to Treat Self-Harm Disparities in Latinas and Sexual/Gender Minority Youth
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