Trial Outcomes & Findings for Adolescent Trauma Recovery and Stress Disorders Collaborative Care (ATRSCC) Model Program Trial (NCT NCT00619255)
NCT ID: NCT00619255
Last Updated: 2018-02-19
Results Overview
Patients with symptoms consistent with a diagnosis of PTSD on the UCLA PTSD Reaction Index were counted. The UCLA PTSD-RI can be used to create an algorithm consistent with a diagnosis of PTSD by rating 1 intrusive, 3 avoidant, and 2 arousal symptoms with a rating of moderate severity. The PTSD-RI is scored on a scale from 0 (none of the time) - 4 (most of the time) with a \> = 2 "some of the time" denoting this cutoff for moderate severity. This algorithm was used to identify patients with high PTSD symptom levels consistent with a diagnosis of PTSD.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
Baseline (injury), then 2, 5, and 12 months post-injury
Results posted on
2018-02-19
Participant Flow
Participant milestones
| Measure |
Intervention
Adolescent Trauma Support Program
Adolescent Trauma Support Program: The study team will be organized into an adolescent trauma support service. The adolescent trauma support service will fundamentally restructure psychosocial care by integrating post-injury medical treatment with alcohol and PTSD detection and treatment. The adolescent trauma support specialists will deliver a stepped collaborative care intervention to adolescents and their families over the 6-12 months post-injury.
|
Control
Usual Care Control Condition
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
61
|
|
Overall Study
COMPLETED
|
57
|
61
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adolescent Trauma Recovery and Stress Disorders Collaborative Care (ATRSCC) Model Program Trial
Baseline characteristics by cohort
| Measure |
Intervention
n=59 Participants
Adolescent Trauma Support Program
Adolescent Trauma Support Program: The study team will be organized into an adolescent trauma support service. The adolescent trauma support service will fundamentally restructure psychosocial care by integrating post-injury medical treatment with alcohol and PTSD detection and treatment. The adolescent trauma support specialists will deliver a stepped collaborative care intervention to adolescents and their families over the 6-12 months post-injury.
|
Control
n=61 Participants
Usual Care Control Condition
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.6 years
STANDARD_DEVIATION 1.9 • n=93 Participants
|
15.4 years
STANDARD_DEVIATION 1.9 • n=4 Participants
|
15.5 years
STANDARD_DEVIATION 1.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
90 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=93 Participants
|
56 Participants
n=4 Participants
|
108 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
7 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
79 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
59 Participants
n=93 Participants
|
61 Participants
n=4 Participants
|
120 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline (injury), then 2, 5, and 12 months post-injuryPatients with symptoms consistent with a diagnosis of PTSD on the UCLA PTSD Reaction Index were counted. The UCLA PTSD-RI can be used to create an algorithm consistent with a diagnosis of PTSD by rating 1 intrusive, 3 avoidant, and 2 arousal symptoms with a rating of moderate severity. The PTSD-RI is scored on a scale from 0 (none of the time) - 4 (most of the time) with a \> = 2 "some of the time" denoting this cutoff for moderate severity. This algorithm was used to identify patients with high PTSD symptom levels consistent with a diagnosis of PTSD.
Outcome measures
| Measure |
Intervention
n=59 Participants
Adolescent Trauma Support Program
Adolescent Trauma Support Program: The study team will be organized into an adolescent trauma support service. The adolescent trauma support service will fundamentally restructure psychosocial care by integrating post-injury medical treatment with alcohol and PTSD detection and treatment. The adolescent trauma support specialists will deliver a stepped collaborative care intervention to adolescents and their families over the 6-12 months post-injury.
|
Control
n=61 Participants
Usual Care Control Condition
|
|---|---|---|
|
Number of Patients With High Levels of Adolescent PTSD Symptoms
Baseline
|
9 Participants
|
12 Participants
|
|
Number of Patients With High Levels of Adolescent PTSD Symptoms
2-months
|
11 Participants
|
12 Participants
|
|
Number of Patients With High Levels of Adolescent PTSD Symptoms
5-months
|
9 Participants
|
13 Participants
|
|
Number of Patients With High Levels of Adolescent PTSD Symptoms
12-months
|
12 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline (injury), and 2, 5, and 12 months post-injuryAny self-reported alcohol or drug use using one yes or no question
Outcome measures
| Measure |
Intervention
n=59 Participants
Adolescent Trauma Support Program
Adolescent Trauma Support Program: The study team will be organized into an adolescent trauma support service. The adolescent trauma support service will fundamentally restructure psychosocial care by integrating post-injury medical treatment with alcohol and PTSD detection and treatment. The adolescent trauma support specialists will deliver a stepped collaborative care intervention to adolescents and their families over the 6-12 months post-injury.
|
Control
n=61 Participants
Usual Care Control Condition
|
|---|---|---|
|
Number of Patients Who Self-reported Alcohol Consumption or Drug Use
Baseline
|
28 Participants
|
25 Participants
|
|
Number of Patients Who Self-reported Alcohol Consumption or Drug Use
2-months
|
18 Participants
|
14 Participants
|
|
Number of Patients Who Self-reported Alcohol Consumption or Drug Use
5-months
|
19 Participants
|
21 Participants
|
|
Number of Patients Who Self-reported Alcohol Consumption or Drug Use
12-months
|
22 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Up to12 months post-injuryPercentage of adolescents self-reporting one or more primary care visits over the course of the 12-months after the injury
Outcome measures
| Measure |
Intervention
n=59 Participants
Adolescent Trauma Support Program
Adolescent Trauma Support Program: The study team will be organized into an adolescent trauma support service. The adolescent trauma support service will fundamentally restructure psychosocial care by integrating post-injury medical treatment with alcohol and PTSD detection and treatment. The adolescent trauma support specialists will deliver a stepped collaborative care intervention to adolescents and their families over the 6-12 months post-injury.
|
Control
n=61 Participants
Usual Care Control Condition
|
|---|---|---|
|
Percentage of Asolescents Linked to Primary Care During the Study
|
43 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: Baseline (injury), then 2, 5, and 12 months post-injurySelf-reported carrying of knife, gun, club or other weapon by adolescent
Outcome measures
| Measure |
Intervention
n=59 Participants
Adolescent Trauma Support Program
Adolescent Trauma Support Program: The study team will be organized into an adolescent trauma support service. The adolescent trauma support service will fundamentally restructure psychosocial care by integrating post-injury medical treatment with alcohol and PTSD detection and treatment. The adolescent trauma support specialists will deliver a stepped collaborative care intervention to adolescents and their families over the 6-12 months post-injury.
|
Control
n=61 Participants
Usual Care Control Condition
|
|---|---|---|
|
Percentage of Adolescents Who Self-reported Weapon Carriage
Baseline
|
20 Participants
|
19 Participants
|
|
Percentage of Adolescents Who Self-reported Weapon Carriage
2-months
|
8 Participants
|
15 Participants
|
|
Percentage of Adolescents Who Self-reported Weapon Carriage
5-months
|
5 Participants
|
13 Participants
|
|
Percentage of Adolescents Who Self-reported Weapon Carriage
12-months
|
4 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline (injury), then 2, 5, and 12 months post-injuryThe investigators used the Patient Health Questionnaire (PHQ-9) to identify symptoms consistent with a diagnosis of depression on the 9-item Patient Health Questionnaire depression screen. Scores range from 1 to 27 with higher scores representing worse outcomes.
Outcome measures
| Measure |
Intervention
n=59 Participants
Adolescent Trauma Support Program
Adolescent Trauma Support Program: The study team will be organized into an adolescent trauma support service. The adolescent trauma support service will fundamentally restructure psychosocial care by integrating post-injury medical treatment with alcohol and PTSD detection and treatment. The adolescent trauma support specialists will deliver a stepped collaborative care intervention to adolescents and their families over the 6-12 months post-injury.
|
Control
n=61 Participants
Usual Care Control Condition
|
|---|---|---|
|
Number of Patients Experiencing High-Level Depressive Symptoms
5-months
|
2 Participants
|
4 Participants
|
|
Number of Patients Experiencing High-Level Depressive Symptoms
Baseline
|
4 Participants
|
8 Participants
|
|
Number of Patients Experiencing High-Level Depressive Symptoms
2-months
|
3 Participants
|
4 Participants
|
|
Number of Patients Experiencing High-Level Depressive Symptoms
12-months
|
7 Participants
|
6 Participants
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention
n=59 participants at risk
Adolescent Trauma Support Program
Adolescent Trauma Support Program: The study team will be organized into an adolescent trauma support service. The adolescent trauma support service will fundamentally restructure psychosocial care by integrating post-injury medical treatment with alcohol and PTSD detection and treatment. The adolescent trauma support specialists will deliver a stepped collaborative care intervention to adolescents and their families over the 6-12 months post-injury.
|
Control
n=61 participants at risk
Usual Care Control Condition
|
|---|---|---|
|
Psychiatric disorders
Suicide ideation
|
23.7%
14/59
|
21.3%
13/61
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place