Treating Violence-related PTSD and Substance Risk in Low-income, Urban Adolescents

NCT03737383 | Completed DMC

• 2 other identifiers: 00000298UL1TR001412
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This project will provide initial feasibility and efficacy data for the implementation of Narrative Exposure Therapy (NET) to urban, at-risk youth. Posttraumatic stress and substance use outcomes, as well as participant responses to the intervention, will be examined.

Conditions

Posttraumatic Stress Disorder; Substance Use Disorders

Outcome Measures

Primary Outcomes (1)

• Posttraumatic Stress Disorder Checklist-Civilian Version

  assessed via PTSD checklist. The minimum score for this measure is 0 while the maximum is 80. Higher scores indicate more severe PTSD symptoms.

  through study completion, an average of 3 years

Secondary Outcomes (2)

• Alcohol Use Disorders Identification Test (AUDIT)

  through study completion, an average of 3 years

• Young Adult Alcohol Consequences Questionnaire (YAACQ)

  through study completion, an average of 3 years

Study Arms (1)

Feasibility and Preliminary Efficacy

EXPERIMENTAL

We will be administering Narrative Exposure Therapy to determine participant responses to the intervention, whether the intervention can be delivered successfully in this setting, and preliminary outcomes.

Behavioral: Narrative Exposure Therapy

Interventions

Narrative Exposure Therapy BEHAVIORAL

brief, trauma-focused treatment.

Also known as: NET

Feasibility and Preliminary Efficacy

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescents (ages 16-25),
• Positive PTSD diagnosis (CAPS diagnosis)
• Positive lifetime incidence of interpersonal violence-related trauma.

You may not qualify if:

• Actively suicidal with an immediate referral to the community agency crisis staff
• Severe cognitive delay
• Active psychosis

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University at Buffalo Department of Psychology

Buffalo, New York, 14260, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Chemically-Induced Disorders

Study Officials

• Stephen Tiffany, Ph.D.

  University at Buffalo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: November 9, 2018
• Study Start: December 1, 2017
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: October 25, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available in June of 2020 and will be available until 2025.
• Access Criteria: There must be an articulation of a clear research question and analytic plan by an established investigator with the relevant credentials. The information will be shared as a digital file through email.

Locations

US (1)