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

Sponsor
State University of New York at Buffalo (Other)
Overall Status
Completed
CT.gov ID
NCT03737383
Collaborator
(none)
21
Enrollment
1
Location
1
Arm
45
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Narrative Exposure Therapy
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treating Violence-related PTSD and Substance Risk in Low-income, Urban Adolescents
Actual Study Start Date :
Dec 1, 2017
Actual Primary Completion Date :
Aug 31, 2021
Actual Study Completion Date :
Aug 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Feasibility and Preliminary Efficacy

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
brief, trauma-focused treatment.
Other Names:
  • NET

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Posttraumatic Stress Disorder Checklist-Civilian Version [through study completion, an average of 3 years]

      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

    1. Alcohol Use Disorders Identification Test (AUDIT) [through study completion, an average of 3 years]

      alcohol use assessed via AUDIT. The minimum score for this measure is 0 while the maximum is 40. Higher scores indicate more alcohol use.

    2. Young Adult Alcohol Consequences Questionnaire (YAACQ) [through study completion, an average of 3 years]

      alcohol consequences assessed via YAACQ. The minimum score for this measure is 0 while the maximum is 48. Higher scores indicate more alcohol consequences.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 25 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University at Buffalo Department of Psychology Buffalo New York United States 14260

    Sponsors and Collaborators

    • State University of New York at Buffalo

    Investigators

    • Study Chair: Stephen Tiffany, Ph.D., University at Buffalo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jennifer Read, Principal Investigator, State University of New York at Buffalo
    ClinicalTrials.gov Identifier:
    NCT03737383
    Other Study ID Numbers:
    • 00000298
    First Posted:
    Nov 9, 2018
    Last Update Posted:
    Mar 23, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Disease
    Substance-Related Disorders
    Stress Disorders, Post-Traumatic

    Study Results

    No Results Posted as of Mar 23, 2022