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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001412 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Narrative Exposure Therapy | Behavioral | brief, trauma-focused treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline, at 1 month follow up, and at 3 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Only 1 participant finished the follow up for 1 month and 3 month (they are a different participant). |
| Young Adult Alcohol Consequences Questionnaire (YAACQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Tiffany, Ph.D. | University at Buffalo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University at Buffalo Department of Psychology | Buffalo | New York | 14260 | United States |
We will share a de-identified data set which will include baseline demographics and trauma, PTSD, and drinking outcomes.
The data will become available in June of 2020 and will be available until 2025.
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.
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We recruited 50 participants for the phase 1 survey, 40 of them finished. We then recruited 74 participants into phase 2 and 60 completed the baseline (different participants than Phase 1). 1 Participant came back for the 1 month follow up. 9 participants came back for the 3 month follow up. 1 of them completed that follow up. The population this study used (homeless teens and young adults) made it extremely difficult to maintain contact so it was hard to follow up resulting in low numbers.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Narrative Exposure Therapy: brief, trauma-focused treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 Baseline (One Time) |
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| Phase 2 Baseline |
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| 1 Month Follow up |
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| 3 Month Follow up |
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This is the baseline results from phase 1 and the baseline from phase 2.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Narrative Exposure Therapy: brief, trauma-focused treatment. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | This is the baseline data from the two different phases of data collection. Together it adds up to the overall population. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | This Outcome Measure was pre-specified to only be assessed in participants enrolled into Phase 2 and no data from Phase 1 participants was collected. Only 1 participant finished the follow up for 1 month and 3 month (they are a different participant). | Posted | Mean | Standard Deviation | score on a scale | At baseline, at 1 month follow up, and at 3 month follow up |
|
At each time point that data was collected so in phase 1, while they completed the questionnaire. And during phase 2 at baseline, 1 month follow up, and 3 month follow up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Questionnaire to Gather Data About Our Sample (Phase 1) | We administered a questionnaire with the goal of having a better understanding of the population before we started conducting an intervention. This was used to better inform us how to conduct Phase 2 of this study. |
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The circumstances of the participants' lives (homeless adolescents) it was extremely challenging to maintain contact so there were small number of participants able to return for follow ups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Read | University at Buffalo | 716 645-0193 | jpread@buffalo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 21, 2018 | Jul 15, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 7, 2018 | Jul 15, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D064419 | Chemically-Induced Disorders |
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alcohol consequences assessed via YAACQ. The minimum score for this measure is 0 while the maximum is 48. Higher scores indicate more alcohol consequences. |
| Only 1 participant finished the follow up for 1 month and 3 month (they are a different participant). |
| Count of Participants |
| Participants |
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| Age, Continuous | This is the baseline data from the two different phases of data collection. Together it adds up to the overall population. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | This is the baseline data from the two different phases of data collection. Together it adds up to the overall population. | Count of Participants | Participants |
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| Race (NIH/OMB) | This is the baseline data from the two different phases of data collection. Together it adds up to the overall population. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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. | This Outcome Measure was pre-specified to only be assessed in participants enrolled into Phase 2 and no data from Phase 1 participants was collected. This measure was only reported on those who reported drinking | Posted | Mean | Standard Deviation | score on a scale | Only 1 participant finished the follow up for 1 month and 3 month (they are a different participant). |
|
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| 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. | This Outcome Measure was pre-specified to only be assessed in participants enrolled into Phase 2 and no data from Phase 1 participants was collected. This measure was only given to those who reported drinking | Posted | Mean | Standard Deviation | score on a scale | Only 1 participant finished the follow up for 1 month and 3 month (they are a different participant). |
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| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Feasibility and Preliminary Efficacy (Phase 2) | 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. Narrative Exposure Therapy: brief, trauma-focused treatment. | 0 | 74 | 0 | 74 | 0 | 74 |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 3 month follow up |
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| 3 month follow up |
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