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

Posttraumatic Stress Disorder Clinical Trial

— POWER-NET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03737383
• Other study ID #: 00000298
• Secondary ID: UL1TR001412
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: August 31, 2021

Study information

• Verified date: October 2023
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Narrative Exposure Therapy
brief, trauma-focused treatment.

Locations

Country	Name	City	State
United States	University at Buffalo Department of Psychology	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York at Buffalo	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	through study completion, an average of 3 years
Secondary	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.	through study completion, an average of 3 years