Trauma Informed Prevention for Substance Use and Risky Sex (TIPS)

December 10, 2021 updated by: Medical University of South Carolina

Mentorship and Research in HIV and Addiction Prevention Among Traumatized Youth

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have experienced at least one traumatic event

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TF-CBT plus TIPS app
Behavioral: TIPS app
Psycho-educational electronic application
Behavioral: Trauma Focused-Cognitive Behavioral Therapy
Effective form of trauma therapy for adolescents
Other Names:
  • TF-CBT
Active Comparator: TF-CBT
Behavioral: Trauma Focused-Cognitive Behavioral Therapy
Effective form of trauma therapy for adolescents
Other Names:
  • TF-CBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pretreatment to 6 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Family Environment Scale
Time Frame: Pretreatment to 6 month follow-up
The Family Environment Scale (FES) is a validated measure that is made up of 26 "true or false" questions that target different interactions that commonly occur within families. We are using two validated subscales from this measure, family conflict and family cohesion. Higher scores on the family conflict subscale are indicative of greater rates of family conflict. Higher rates on the family cohesion subscale are indicative of higher rates of family cohesion. The measure aims to detect an increase in positive family environment over time.
Pretreatment to 6 month follow-up
Bad Friends Subscale of the Pittsburgh Youth Study
Time Frame: Pretreatment to 6 month follow-up
The Bad Friends Subscale of the Pittsburg Youth Study (Youth-Friends Scale) is a validated measure made up of eight questions (both fill-in-the-blank and yes/no) that aim to detect caregiver approval of adolescent peer groups and whether caregiver opinions are considered in future peer interactions. The scale aims to detect a decrease in negative peers over time. Answers are qualitative in nature. In general, the rater looks for themes in regards to whether the youth spends time with negative peers (that the caregiver does not approve of).
Pretreatment to 6 month follow-up
Alabama Parenting Questionnaire
Time Frame: Pretreatment to 6 month follow-up
The Alabama Parenting Questionnaire (APQ) is a validated measure consisting of questions that look into family interactions and, more specifically, interactions between youth and caregiver. The scale is scored on a five-point Likert scale that ranges from "never" (score of 1) to "always" (score of 5) when looking at how often certain behaviors occur within the home. High scores on the positive parenting subscale and low scores on the poor monitoring/supervision, inconsistent discipline, and corporal punishment subscales are indicative of positive parenting.
Pretreatment to 6 month follow-up
UCLA PTSD Index DSM-V
Time Frame: Pretreatment to 6 month follow-up
The UCLA Post Traumatic Stress Disorder Index DSM-IV (UCLA PTSD Index DSM-IV) is a validated, subjective measure that consists of 23 yes or no questions regarding the occurrence of different traumas or losses that may happen during a child's life. Each question is followed up with details of the trauma that occurred and more extensive questioning for the trauma experienced that is still most bothersome in the present day. These follow-up questions gauge symptoms of PTSD on a five-point Likert scale that ranges from "none" (score of 0, no days has this symptom occurred in the last month) to "most" (score of 4, symptom occurred almost every day in the past month). The most traumatic experience is also followed by several yes/no questions that gauge distress and functional impairment. Higher scores are indicative of higher rates of PTSD symptoms.
Pretreatment to 6 month follow-up
Children's Depression Inventory
Time Frame: Pretreatment to 6 month follow-up
The Children's Depression Inventory (CDI) is a validated measure that consists of 27 multiple choice items that gauge depressive behaviors/symptoms in youth. The items each have three choices that are best described as "Never/Rarely," "Many," or "All" in regards to each behavior in question. Higher scores are indicative of higher rates of depressive symptoms.
Pretreatment to 6 month follow-up
Timeline Follow Back (TLFM)-Form 90
Time Frame: Pretreatment to 6 month follow-up
The Timeline Follow Back (TLFB) is a validated, subjective measure that uses a calendar for people to provide estimates of substance use (drugs/alcohol) on a daily basis, retrospectively. Key dates and calendars are used to aid in memory recall. The measure is beneficial in both clinical and research environments. Over time, the TLFB looks for a decrease in alcohol use. Higher numbers of substance use are indicative of greater substance use.
Pretreatment to 6 month follow-up
CRAFFT Screening Tool for Adolescent Substance Abuse
Time Frame: Pretreatment to 6 month follow-up
Scores of two or more are indicative of a probable substance use problem.
Pretreatment to 6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Carla K Danielson, PhD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2019

Primary Completion (Actual)

December 23, 2020

Study Completion (Actual)

December 23, 2020

Study Registration Dates

First Submitted

October 15, 2018

First Submitted That Met QC Criteria

October 15, 2018

First Posted (Actual)

October 18, 2018

Study Record Updates

Last Update Posted (Actual)

December 13, 2021

Last Update Submitted That Met QC Criteria

December 10, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00041527

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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