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Treating Violence-related PTSD and Substance Risk in Low-income, Urban Adolescents (POWER-NET)

Primary Purpose

Posttraumatic Stress Disorder, Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Narrative Exposure Therapy
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder

Eligibility Criteria

16 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • University at Buffalo Department of Psychology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Feasibility and Preliminary Efficacy

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Alcohol Use Disorders Identification Test (AUDIT)
alcohol use assessed via AUDIT. The minimum score for this measure is 0 while the maximum is 40. Higher scores indicate more alcohol use.
Young Adult Alcohol Consequences Questionnaire (YAACQ)
alcohol consequences assessed via YAACQ. The minimum score for this measure is 0 while the maximum is 48. Higher scores indicate more alcohol consequences.

Full Information

First Posted
January 29, 2018
Last Updated
October 23, 2023
Sponsor
State University of New York at Buffalo
Collaborators
National Center for Advancing Translational Sciences (NCATS)
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1. Study Identification

Unique Protocol Identification Number
NCT03737383
Brief Title
Treating Violence-related PTSD and Substance Risk in Low-income, Urban Adolescents
Acronym
POWER-NET
Official Title
Treating Violence-related PTSD and Substance Risk in Low-income, Urban Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
Collaborators
National Center for Advancing Translational Sciences (NCATS)

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
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.
Detailed Description
The goal of the proposed study is to gather preliminary feasibility and efficacy data for an innovative intervention (Narrative Exposure Therapy: NET) to promote adolescent mental health related to interpersonal trauma (IPT). Among those at highest risk for interpersonal violence and its sequelae are youth from urban, low-resourced neighborhoods. Post-traumatic stress disorder (PTSD) is a common outcome associated with IPT. Substance misuse (SUB) is a frequent concomitant of PTSD. NET is a promising intervention to reduce PTSD symptoms and associated psychological distress, via the supported reconstruction (narrative telling) of the traumas. NET has a critical advantage over existing PTSD treatments in that it can be delivered in a brief format, in community settings where at-risk adolescents are likely to be found. Despite its promise in treating adolescent distress, NET has yet to be tested as an intervention for those who have interpersonal trauma-related PTSD. Further NET's influence on SUB has not been examined. Accordingly, the objective of this project is to conduct a pilot study (N=30) to estimate NET treatment effects on PTSD symptoms and SUB in IPT-exposed urban adolescents (ages 16-21). Both feasibility and preliminary efficacy data will be collected to serve as pilot work for a larger-scale NIH proposal. Recruitment and intervention will be set within community partners where the adolescents already are connected and are receiving social or psychological services. Outcome data will be collected at: (T0) Baseline, and at 1(T1), and 3 months (T2) follow-up assessments. Participant responses to the intervention will be assessed post-intervention. Change in PTSD, SUB will be estimated with effect sizes and inferential tests. Preliminary evidence of efficacy and feasibility will pave the way for further NET development to offer a patient-oriented, community-based, intervention that will promote adolescent mental health for those at greatest risk for health access and outcomes disparities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Substance Use Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Feasibility and Preliminary Efficacy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Narrative Exposure Therapy
Other Intervention Name(s)
NET
Intervention Description
brief, trauma-focused treatment.
Primary Outcome Measure Information:
Title
Posttraumatic Stress Disorder Checklist-Civilian Version
Description
assessed via PTSD checklist. The minimum score for this measure is 0 while the maximum is 80. Higher scores indicate more severe PTSD symptoms.
Time Frame
through study completion, an average of 3 years
Secondary Outcome Measure Information:
Title
Alcohol Use Disorders Identification Test (AUDIT)
Description
alcohol use assessed via AUDIT. The minimum score for this measure is 0 while the maximum is 40. Higher scores indicate more alcohol use.
Time Frame
through study completion, an average of 3 years
Title
Young Adult Alcohol Consequences Questionnaire (YAACQ)
Description
alcohol consequences assessed via YAACQ. The minimum score for this measure is 0 while the maximum is 48. Higher scores indicate more alcohol consequences.
Time Frame
through study completion, an average of 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adolescents (ages 16-25), Positive PTSD diagnosis (CAPS diagnosis) Positive lifetime incidence of interpersonal violence-related trauma. Exclusion Criteria: Actively suicidal with an immediate referral to the community agency crisis staff Severe cognitive delay Active psychosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Tiffany, Ph.D.
Organizational Affiliation
University at Buffalo
Official's Role
Study Chair
Facility Information:
Facility Name
University at Buffalo Department of Psychology
City
Buffalo
State/Province
New York
ZIP/Postal Code
14260
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We will share a de-identified data set which will include baseline demographics and trauma, PTSD, and drinking outcomes.
IPD Sharing Time Frame
The data will become available in June of 2020 and will be available until 2025.
IPD Sharing 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.

Learn more about this trial

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

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