Trial Outcomes & Findings for Treating Violence-related PTSD and Substance Risk in Low-income, Urban Adolescents (NCT NCT03737383)
NCT ID: NCT03737383
Last Updated: 2026-05-15
Results Overview
assessed via PTSD checklist. The minimum score for this measure is 0 while the maximum is 80. Higher scores indicate more severe PTSD symptoms.
COMPLETED
NA
124 participants
At baseline, at 1 month follow up, and at 3 month follow up
2026-05-15
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Phase 1 Baseline (One Time)
STARTED
|
50
|
|
Phase 1 Baseline (One Time)
COMPLETED
|
40
|
|
Phase 1 Baseline (One Time)
NOT COMPLETED
|
10
|
|
Phase 2 Baseline
STARTED
|
74
|
|
Phase 2 Baseline
COMPLETED
|
60
|
|
Phase 2 Baseline
NOT COMPLETED
|
14
|
|
1 Month Follow up
STARTED
|
1
|
|
1 Month Follow up
COMPLETED
|
1
|
|
1 Month Follow up
NOT COMPLETED
|
0
|
|
3 Month Follow up
STARTED
|
9
|
|
3 Month Follow up
COMPLETED
|
1
|
|
3 Month Follow up
NOT COMPLETED
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This is the baseline data from the two different phases of data collection. Together it adds up to the overall population.
Baseline characteristics by cohort
| Measure |
Feasibility and Preliminary Efficacy
n=100 Participants
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.
|
|---|---|
|
Age, Categorical
Baseline (Phase 1) · <=18 years
|
16 Participants
n=40 Participants • This is the baseline data from the two different phases of data collection. Together it adds up to the overall population.
|
|
Age, Categorical
Baseline (Phase 1) · Between 18 and 65 years
|
24 Participants
n=40 Participants • This is the baseline data from the two different phases of data collection. Together it adds up to the overall population.
|
|
Age, Categorical
Baseline (Phase 1) · >=65 years
|
0 Participants
n=40 Participants • This is the baseline data from the two different phases of data collection. Together it adds up to the overall population.
|
|
Age, Categorical
Baseline (Phase 2) · <=18 years
|
11 Participants
n=60 Participants • This is the baseline data from the two different phases of data collection. Together it adds up to the overall population.
|
|
Age, Categorical
Baseline (Phase 2) · Between 18 and 65 years
|
49 Participants
n=60 Participants • This is the baseline data from the two different phases of data collection. Together it adds up to the overall population.
|
|
Age, Categorical
Baseline (Phase 2) · >=65 years
|
0 Participants
n=60 Participants • This is the baseline data from the two different phases of data collection. Together it adds up to the overall population.
|
|
Age, Continuous
Baseline (phase 1 and phase 2)
|
18.95 years
STANDARD_DEVIATION 2.51 • n=40 Participants • This is the baseline data from the two different phases of data collection. Together it adds up to the overall population.
|
|
Age, Continuous
Baseline (phase 2)
|
19.66 years
STANDARD_DEVIATION 2.35 • n=60 Participants • This is the baseline data from the two different phases of data collection. Together it adds up to the overall population.
|
|
Sex: Female, Male
Baseline (Phase 1) · Female
|
20 Participants
n=40 Participants • This is the baseline data from the two different phases of data collection. Together it adds up to the overall population.
|
|
Sex: Female, Male
Baseline (Phase 1) · Male
|
20 Participants
n=40 Participants • This is the baseline data from the two different phases of data collection. Together it adds up to the overall population.
|
|
Sex: Female, Male
Baseline (Phase 2) · Female
|
16 Participants
n=60 Participants • This is the baseline data from the two different phases of data collection. Together it adds up to the overall population.
|
|
Sex: Female, Male
Baseline (Phase 2) · Male
|
44 Participants
n=60 Participants • This is the baseline data from the two different phases of data collection. Together it adds up to the overall population.
|
|
Race (NIH/OMB)
Baseline (Phase 1) · American Indian or Alaska Native
|
0 Participants
n=40 Participants • This is the baseline data from the two different phases of data collection. Together it adds up to the overall population.
|
|
Race (NIH/OMB)
Baseline (Phase 1) · Asian
|
0 Participants
n=40 Participants • This is the baseline data from the two different phases of data collection. Together it adds up to the overall population.
|
|
Race (NIH/OMB)
Baseline (Phase 1) · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=40 Participants • This is the baseline data from the two different phases of data collection. Together it adds up to the overall population.
|
|
Race (NIH/OMB)
Baseline (Phase 1) · Black or African American
|
20 Participants
n=40 Participants • This is the baseline data from the two different phases of data collection. Together it adds up to the overall population.
|
|
Race (NIH/OMB)
Baseline (Phase 1) · White
|
9 Participants
n=40 Participants • This is the baseline data from the two different phases of data collection. Together it adds up to the overall population.
|
|
Race (NIH/OMB)
Baseline (Phase 1) · More than one race
|
7 Participants
n=40 Participants • This is the baseline data from the two different phases of data collection. Together it adds up to the overall population.
|
|
Race (NIH/OMB)
Baseline (Phase 1) · Unknown or Not Reported
|
3 Participants
n=40 Participants • This is the baseline data from the two different phases of data collection. Together it adds up to the overall population.
|
|
Race (NIH/OMB)
Baseline (Phase 2) · American Indian or Alaska Native
|
1 Participants
n=60 Participants • This is the baseline data from the two different phases of data collection. Together it adds up to the overall population.
|
|
Race (NIH/OMB)
Baseline (Phase 2) · Asian
|
0 Participants
n=60 Participants • This is the baseline data from the two different phases of data collection. Together it adds up to the overall population.
|
|
Race (NIH/OMB)
Baseline (Phase 2) · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=60 Participants • This is the baseline data from the two different phases of data collection. Together it adds up to the overall population.
|
|
Race (NIH/OMB)
Baseline (Phase 2) · Black or African American
|
33 Participants
n=60 Participants • This is the baseline data from the two different phases of data collection. Together it adds up to the overall population.
|
|
Race (NIH/OMB)
Baseline (Phase 2) · White
|
14 Participants
n=60 Participants • This is the baseline data from the two different phases of data collection. Together it adds up to the overall population.
|
|
Race (NIH/OMB)
Baseline (Phase 2) · More than one race
|
6 Participants
n=60 Participants • This is the baseline data from the two different phases of data collection. Together it adds up to the overall population.
|
|
Race (NIH/OMB)
Baseline (Phase 2) · Unknown or Not Reported
|
5 Participants
n=60 Participants • This is the baseline data from the two different phases of data collection. Together it adds up to the overall population.
|
|
Region of Enrollment
United States
|
100 participants
n=100 Participants
|
PRIMARY outcome
Timeframe: At baseline, at 1 month follow up, and at 3 month follow upPopulation: 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).
assessed via PTSD checklist. The minimum score for this measure is 0 while the maximum is 80. Higher scores indicate more severe PTSD symptoms.
Outcome measures
| Measure |
Feasibility and Preliminary Efficacy
n=62 Participants
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.
|
|---|---|
|
Posttraumatic Stress Disorder Checklist-Civilian Version
Baseline
|
31.45 score on a scale
Standard Deviation 20.00
|
|
Posttraumatic Stress Disorder Checklist-Civilian Version
1 Month follow up
|
46 score on a scale
Standard Deviation 0
|
|
Posttraumatic Stress Disorder Checklist-Civilian Version
3 month follow up
|
18 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Only 1 participant finished the follow up for 1 month and 3 month (they are a different participant).Population: 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
alcohol use assessed via AUDIT. The minimum score for this measure is 0 while the maximum is 40. Higher scores indicate more alcohol use.
Outcome measures
| Measure |
Feasibility and Preliminary Efficacy
n=62 Participants
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.
|
|---|---|
|
Alcohol Use Disorders Identification Test (AUDIT)
Baseline
|
5.12 score on a scale
Standard Deviation 7.05
|
|
Alcohol Use Disorders Identification Test (AUDIT)
1 month follow up
|
0 score on a scale
Standard Deviation 0
|
|
Alcohol Use Disorders Identification Test (AUDIT)
3 month follow up
|
0 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Only 1 participant finished the follow up for 1 month and 3 month (they are a different participant).Population: 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
alcohol consequences assessed via YAACQ. The minimum score for this measure is 0 while the maximum is 48. Higher scores indicate more alcohol consequences.
Outcome measures
| Measure |
Feasibility and Preliminary Efficacy
n=62 Participants
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.
|
|---|---|
|
Young Adult Alcohol Consequences Questionnaire (YAACQ)
baseline
|
7.65 score on a scale
Standard Deviation 9.90
|
|
Young Adult Alcohol Consequences Questionnaire (YAACQ)
1 month follow up
|
0 score on a scale
Standard Deviation 0
|
|
Young Adult Alcohol Consequences Questionnaire (YAACQ)
3 month follow up
|
0 score on a scale
Standard Deviation 0
|
Adverse Events
Questionnaire to Gather Data About Our Sample (Phase 1)
Feasibility and Preliminary Efficacy (Phase 2)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place