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Computer Assisted CIFFTA for Self-Harm

N/A
Waitlist Available
Led By Daniel Santisteban, Ph.D.
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The adolescent must self-report an act of self-harm in the past 6 months
The adolescent must meet criteria for cut-off on two of the four underlying/maintaining factors (depression, emotion dysregulation, family conflict, substance use)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 months post baseline, 12 months post baseline
Awards & highlights

Study Summary

This trial will help researchers understand how to better treat self-harm in Latino adolescents, specifically Latinas and sexual/gender minority youth.

Eligible Conditions
  • Self-Harm
  • Depression
  • Behavioral Problem
  • Emotional Dysregulation

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
The teenager has intentionally hurt themselves in the past 6 months.
Select...
The teenager must have significant problems in at least two of the following areas: feeling sad or down, difficulty controlling their emotions, conflicts within their family, or using substances like drugs or alcohol.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 months post baseline, 12 months post baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 months post baseline, 12 months post baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in self harm behavior
Secondary outcome measures
Emotional Dysregulation
Family Functioning
Risky Sexual Behavior
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Computer Assisted CIFFTAExperimental Treatment1 Intervention
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
Group II: Behavioral: Traditional face-to-face treatment-no technologyActive Control1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computer Assisted CIFFTA
2018
N/A
~90

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
897 Previous Clinical Trials
409,176 Total Patients Enrolled
National Institute on Minority Health and Health Disparities (NIMHD)NIH
373 Previous Clinical Trials
1,214,372 Total Patients Enrolled
Daniel Santisteban, Ph.D.Principal InvestigatorUniversity of Miami

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this medical trial still open?

"This experiment is still open for enrolment, as indicated on clinicaltrials.gov. The trial was initially published on November 12th 2018 and last updated April 21st 2022."

Answered by AI

Who is eligible to sign up for the experiment?

"This trial requires 100 minors between 11 and 18 years of age that have been diagnosed with depression to partake. Furthermore, applicants must be willing and able to adhere to the entire protocol (e.g., consenting for recordings during treatment sessions). It is also necessary that a parent or guardian agrees to collaborate in assessments and treatments."

Answered by AI

What is the aggregate number of individuals participating in this investigation?

"Confirmed. Clinicaltrials.gov documents this medical trial's commencement on November 12th 2018 as well as its most recent update on April 21st 2022, and that it is recruiting 100 patients at a single location."

Answered by AI

Could persons above the age of 20 be accepted into this clinical trial?

"This clinical trial allows participants aged between 11 and 18 years old, which is outlined in the inclusion criteria."

Answered by AI
~13 spots leftby Mar 2025