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

Primary Purpose

Substance Use, HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TIPS app
Trauma Focused-Cognitive Behavioral Therapy
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Use focused on measuring Traumatic stress, substance use prevention, HIV prevention, adolescents

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TF-CBT plus TIPS app

TF-CBT

Arm Description

Outcomes

Primary Outcome Measures

Risky Sexual Behaviors Scale
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 Outcome Measures

Family Environment Scale
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.
Bad Friends Subscale of the Pittsburgh Youth Study
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).
Alabama Parenting Questionnaire
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.
UCLA PTSD Index DSM-V
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.
Children's Depression Inventory
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.
Timeline Follow Back (TLFM)-Form 90
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.
CRAFFT Screening Tool for Adolescent Substance Abuse
Scores of two or more are indicative of a probable substance use problem.

Full Information

First Posted
October 15, 2018
Last Updated
December 10, 2021
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03710720
Brief Title
Trauma Informed Prevention for Substance Use and Risky Sex
Acronym
TIPS
Official Title
Mentorship and Research in HIV and Addiction Prevention Among Traumatized Youth
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 9, 2019 (Actual)
Primary Completion Date
December 23, 2020 (Actual)
Study Completion Date
December 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, HIV/AIDS
Keywords
Traumatic stress, substance use prevention, HIV prevention, adolescents

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Urn randomization will be monitored by the Principal Investigator.
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TF-CBT plus TIPS app
Arm Type
Experimental
Arm Title
TF-CBT
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
TIPS app
Intervention Description
Psycho-educational electronic application
Intervention Type
Behavioral
Intervention Name(s)
Trauma Focused-Cognitive Behavioral Therapy
Other Intervention Name(s)
TF-CBT
Intervention Description
Effective form of trauma therapy for adolescents
Primary Outcome Measure Information:
Title
Risky Sexual Behaviors Scale
Description
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.
Time Frame
Pretreatment to 6 month follow-up
Secondary Outcome Measure Information:
Title
Family Environment Scale
Description
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.
Time Frame
Pretreatment to 6 month follow-up
Title
Bad Friends Subscale of the Pittsburgh Youth Study
Description
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).
Time Frame
Pretreatment to 6 month follow-up
Title
Alabama Parenting Questionnaire
Description
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.
Time Frame
Pretreatment to 6 month follow-up
Title
UCLA PTSD Index DSM-V
Description
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.
Time Frame
Pretreatment to 6 month follow-up
Title
Children's Depression Inventory
Description
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.
Time Frame
Pretreatment to 6 month follow-up
Title
Timeline Follow Back (TLFM)-Form 90
Description
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.
Time Frame
Pretreatment to 6 month follow-up
Title
CRAFFT Screening Tool for Adolescent Substance Abuse
Description
Scores of two or more are indicative of a probable substance use problem.
Time Frame
Pretreatment to 6 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carla K Danielson, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Trauma Informed Prevention for Substance Use and Risky Sex

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