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Trauma Informed Prevention for Substance Use and Risky Sex

NCT ID: NCT03710720

Last Updated: 2021-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-09

Study Completion Date

2020-12-23

Brief Summary

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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

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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.

Conditions

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Substance Use HIV/AIDS

Keywords

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Traumatic stress substance use prevention HIV prevention adolescents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Urn randomization will be monitored by the Principal Investigator.

Study Groups

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TF-CBT plus TIPS app

Group Type EXPERIMENTAL

TIPS app

Intervention Type BEHAVIORAL

Psycho-educational electronic application

Trauma Focused-Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

Effective form of trauma therapy for adolescents

TF-CBT

Group Type ACTIVE_COMPARATOR

Trauma Focused-Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

Effective form of trauma therapy for adolescents

Interventions

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TIPS app

Psycho-educational electronic application

Intervention Type BEHAVIORAL

Trauma Focused-Cognitive Behavioral Therapy

Effective form of trauma therapy for adolescents

Intervention Type BEHAVIORAL

Other Intervention Names

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TF-CBT

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carla K Danielson, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38236634 (View on PubMed)

Other Identifiers

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Pro00041527

Identifier Type: -

Identifier Source: org_study_id