NCT03710720

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

January 9, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2020

Completed
Last Updated

December 13, 2021

Status Verified

December 1, 2021

Enrollment Period

2 years

First QC Date

October 15, 2018

Last Update Submit

December 10, 2021

Conditions

Substance UseHIV/AIDS

Keywords

Traumatic stresssubstance use preventionHIV preventionadolescents

Outcome Measures

Primary Outcomes (1)

  • 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.

    Pretreatment to 6 month follow-up

Secondary Outcomes (7)

  • Family Environment Scale

    Pretreatment to 6 month follow-up

  • Bad Friends Subscale of the Pittsburgh Youth Study

    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

  • Children's Depression Inventory

    Pretreatment to 6 month follow-up

  • +2 more secondary outcomes

Study Arms (2)

TF-CBT plus TIPS app

EXPERIMENTAL
Behavioral: TIPS appBehavioral: Trauma Focused-Cognitive Behavioral Therapy

TF-CBT

ACTIVE COMPARATOR
Behavioral: Trauma Focused-Cognitive Behavioral Therapy

Interventions

TIPS appBEHAVIORAL

Psycho-educational electronic application

TF-CBT plus TIPS app
Trauma Focused-Cognitive Behavioral TherapyBEHAVIORAL

Effective form of trauma therapy for adolescents

Also known as: TF-CBT
TF-CBTTF-CBT plus TIPS app

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Have experienced at least one traumatic event

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

  • Danielson CK, Moreland A, Hahn A, Banks D, Ruggiero KJ. Development and Usability Testing of an mHealth Tool for Trauma-Informed Prevention of Substance Use, HIV Acquisition, and Risky Sexual Behaviors Among Adolescents: Mixed Methods Study. JMIR Form Res. 2024 Jan 18;8:e52835. doi: 10.2196/52835.

    PMID: 38236634DERIVED

MeSH Terms

Conditions

Substance-Related DisordersAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Carla K Danielson, PhD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Urn randomization will be monitored by the Principal Investigator.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2018

First Posted

October 18, 2018

Study Start

January 9, 2019

Primary Completion

December 23, 2020

Study Completion

December 23, 2020

Last Updated

December 13, 2021

Record last verified: 2021-12

Locations

US(1)