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Clinical Trials/NCT03710720
NCT03710720CompletedNot Applicable

Mentorship and Research in HIV and Addiction Prevention Among Traumatized Youth

Medical University of South Carolina2 sites in 1 country62 target enrollmentStarted: January 9, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
62
Locations
2
Primary Endpoint
Risky Sexual Behaviors Scale

Study Overview

Brief Summary

The purpose of this research study is to determine the usefulness of the TIPS iPad app in the treatment of adolescent patients who qualify for Trauma Focused-Cognitive Behavioral Therapy (TF-CBT).

Detailed Description

The primary goal of this study is to conduct a feasibility test of the delivery of the TIPS app during implementation of TF-CBT in comparison to TF-CBT as it is usually administered, as well as feasibility of methods that would be utilized in a larger scale evaluation of the toolkit. Clients will be randomly assigned to one of the two conditions, TF-CBT plus the TIPS app or TF-CBT as usual. Study duration is six months and includes four total assessments, which will be completed by hand. These assessments will occur over the 12-16 weeks of TF-CBT that clients would receive whether they choose to participate in the study or not. Participation in this study may broaden your child's treatment to target prevention of risk behaviors, but that cannot be guaranteed.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Masking Description

Urn randomization will be monitored by the Principal Investigator.

Eligibility Criteria

Ages
12 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Have experienced at least one traumatic event

Exclusion Criteria

  • Adolescents exhibiting psychotic symptoms
  • Significant cognitive disability
  • Active suicidal or homicidal ideations
  • Meets criteria for a DSM-5 moderate or severe substance use disorder

Outcomes

Primary Outcomes

Risky Sexual Behaviors Scale

Time Frame: Pretreatment to 6 month follow-up

The Risky Sexual Behaviors Scale (RSBS) is a validated measure that was originally created to gain more insight on the behaviors of a population of homeless adolescents. The scale measures increased risk of STDs through four major scale items. The RSBS uses a five-point Likert scale that targets caregiver involvement in discussions surrounding sexual behaviors with the option for least involved being "never" (score of 1) and the greatest involved being "always" (score of 5). The scale also includes fill-in-the-blank questions that gauge the number of "times" an adolescent has engaged in a specific behavior in the past 30 days and the past 90 days. Higher scores are indicative of higher rates of risky sexual behaviors.

Secondary Outcomes

  • Children's Depression Inventory(Pretreatment to 6 month follow-up)
  • Alabama Parenting Questionnaire(Pretreatment to 6 month follow-up)
  • UCLA PTSD Index DSM-V(Pretreatment to 6 month follow-up)
  • Family Environment Scale(Pretreatment to 6 month follow-up)
  • Bad Friends Subscale of the Pittsburgh Youth Study(Pretreatment to 6 month follow-up)
  • CRAFFT Screening Tool for Adolescent Substance Abuse(Pretreatment to 6 month follow-up)
  • Timeline Follow Back (TLFM)-Form 90(Pretreatment to 6 month follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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