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

• ClinicalTrials.gov Identifier: NCT03710720
• Recruitment Status: Completed
• First Posted: October 18, 2018
• Last Update Posted: December 13, 2021
• Sponsor: Medical University of South Carolina
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): Medical University of South Carolina

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).

Condition or disease	Intervention/treatment	Phase
Substance Use; HIV/AIDS	Behavioral: TIPS app; Behavioral: Trauma Focused-Cognitive Behavioral Therapy	Not Applicable

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 (Clinical Trial)
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: Urn randomization will be monitored by the Principal Investigator.
• Primary Purpose: Prevention
• Official Title: Mentorship and Research in HIV and Addiction Prevention Among Traumatized Youth
• Actual Study Start Date: January 9, 2019
• Actual Primary Completion Date: December 23, 2020
• Actual Study Completion Date: December 23, 2020

Arms and Interventions

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 Name: TF-CBT
Active Comparator: TF-CBT	Behavioral: Trauma Focused-Cognitive Behavioral Therapy; Effective form of trauma therapy for adolescents; Other Name: TF-CBT

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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.
2. 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).
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

Medical University of South Carolina

National Institute on Drug Abuse (NIDA)

Investigators

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

More Information

• Responsible Party: Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT03710720
• Other Study ID Numbers: Pro00041527
• First Posted: October 18, 2018
• Last Update Posted: December 13, 2021
• Last Verified: December 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Medical University of South Carolina:

Traumatic stress; substance use prevention; HIV prevention; adolescents

Additional relevant MeSH terms:

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders