Clinical trial NCT03737383: Treating Violence-related PTSD and Substance Risk in Low-income, Urban Adolescents
Official title: Treating Violence-related PTSD and Substance Risk in Low-income, Urban Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Substance Use Disorders
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2018-11-09
Enrollment: 21
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Posttraumatic Stress Disorder Checklist-Civilian Version
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: through study completion, an average of 3 years
measure: Young Adult Alcohol Consequences Questionnaire (YAACQ)
timeFrame: through study completion, an average of 3 years
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo Department of Psychology
state: New York
Study officials:
affiliation: University at Buffalo
name: Stephen Tiffany, Ph.D.
role: STUDY_CHAIR
References: