An interventional study of Adolescent Trauma Support Program in Post-traumatic Stress Disorder, Alcohol Abuse and Alcohol Dependence, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-02-19.
Sponsored by University of Washington · Not applicable, Interventional, and Treatment
Recent needs assessments suggest that difficulties exist in care coordination between emergency medical services (EMS) systems and primary care for injured adolescents with alcohol problems and post-traumatic stress disorder (PTSD). This project will implement, evaluate, and disseminate the adolescent trauma support service model program that aims to enhance coordination between EMS systems and primary care/community services.
Goal 1: To coordinate care from EMS systems to primary care for injured adolescents.
Objective 1: To increase rates of connection to primary care providers to 55% for model program adolescents, compared to an anticipated connection rate of 25% in adolescents assigned to standard care, by 2010.
Goal 2: To reduce alcohol consumption over the course of the year after injury.
Objective 2: To reduce rates of alcohol consumption by 25% in adolescents assigned to the model program, compared to adolescents assigned to the standard care, by 2010.
Goal 3: To reduce adolescent PTSD symptoms over the course of the year after injury.
Objective 3: To achieve statistically significant reductions in PTSD symptoms in model program patients, compared to adolescents assigned to standard care, by 2010.
Activities Undertaken to Meet Project Goals:
We propose to implement and evaluate an innovative model program, the adolescent trauma support service, that aims to improve the quality of care for injured adolescents with problematic alcohol use and high levels of PTSD symptoms by enhancing coordination of care between EMS systems and primary care and community services. All injured adolescents ages 12-18 presenting to the Harborview Medical Center with injuries so severe that they require inpatient admission and/or 24 hour observation in the emergency department, will be screened for alcohol use and PTSD. Adolescents who screen into the study will be randomly assigned to the adolescent trauma support service or standard care. Two trauma support specialists will meet each injured adolescent and available family members by the ED gurney or inpatient bedside in order to elicit and address each patient/family's unique constellation of post-injury concerns. Next, the adolescent trauma support specialist will help to coordinate care received within the EMS system with primary care providers. The trauma support specialists will also have the capacity to deliver evidence-based motivational interviewing interventions targeting reductions in adolescent alcohol use. The trauma support specialists will link patients and families to evidence-based PTSD treatment through primary care and community resources. Program evaluation will include a comparison of the outcomes of adolescents randomly assigned to the adolescent trauma support program with those of adolescents assigned to standard care. Adolescents in the model program and standard care will be compared on the presence or absence of post-injury primary care visits and reductions in alcohol use and PTSD symptoms over the course of the year after injury. Nationwide dissemination activities of program evaluation results will include the publication of manuscripts in peer reviewed journals and presentations at national meetings by members of the interdisciplinary collaborative group that includes pediatric, mental health and surgical providers.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 120 is above the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Adolescent Trauma Support Program
Behavioral: Adolescent Trauma Support Program
Usual Care Control Condition
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.
Number of Patients With High Levels of Adolescent PTSD Symptoms
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.
Time frame: Baseline (injury), then 2, 5, and 12 months post-injury
Number of Patients Who Self-reported Alcohol Consumption or Drug Use
Any self-reported alcohol or drug use using one yes or no question
Time frame: Baseline (injury), and 2, 5, and 12 months post-injury
Percentage of Asolescents Linked to Primary Care During the Study
Percentage of adolescents self-reporting one or more primary care visits over the course of the 12-months after the injury
Time frame: Up to12 months post-injury
Percentage of Adolescents Who Self-reported Weapon Carriage
Self-reported carrying of knife, gun, club or other weapon by adolescent
Time frame: Baseline (injury), then 2, 5, and 12 months post-injury
Number of Patients Experiencing High-Level Depressive Symptoms
The 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.
Time frame: Baseline (injury), then 2, 5, and 12 months post-injury
| Milestone | Intervention | Control |
|---|---|---|
| Started | 59 | 61 |
| Completed | 57 | 61 |
| Not completed | 2 | 0 |
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.
| Participants | Intervention | Control |
|---|---|---|
| Baseline | 9 | 12 |
| 2-months | 11 | 12 |
| 5-months | 9 | 13 |
| 12-months | 12 | 9 |
Any self-reported alcohol or drug use using one yes or no question
| Participants | Intervention | Control |
|---|---|---|
| Baseline | 28 | 25 |
| 2-months | 18 | 14 |
| 5-months | 19 | 21 |
| 12-months | 22 | 26 |
Percentage of adolescents self-reporting one or more primary care visits over the course of the 12-months after the injury
| Participants | Intervention | Control |
|---|---|---|
| Percentage of Asolescents Linked to Primary Care During the Study | 43 | 48 |
Self-reported carrying of knife, gun, club or other weapon by adolescent
| Participants | Intervention | Control |
|---|---|---|
| Baseline | 20 | 19 |
| 2-months | 8 | 15 |
| 5-months | 5 | 13 |
| 12-months | 4 | 13 |
The 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.
| Participants | Intervention | Control |
|---|---|---|
| Baseline | 4 | 8 |
| 2-months | 3 | 4 |
| 5-months | 2 | 4 |
| 12-months | 7 | 6 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/59 (0%) | 0/59 (0%) | 14/59 (23.7%) |
| Control | 0/61 (0%) | 0/61 (0%) | 13/61 (21.3%) |
| Event | Intervention | Control |
|---|---|---|
| Suicide ideationPsychiatric disorders | 14/59 | 13/61 |
| Age, Continuous(years) | Intervention | Control | Total |
|---|---|---|---|
| Mean | 15.6 ± 1.9 | 15.4 ± 1.9 | 15.5 ± 1.9 |
| Sex: Female, Male(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Female | 14 | 16 | 30 |
| Male | 45 | 45 | 90 |
| Ethnicity (NIH/OMB)(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 5 | 11 |
| Not Hispanic or Latino | 52 | 56 | 108 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Intervention | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 7 | 2 | 9 |
| Asian | 5 | 3 | 8 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 6 | 7 |
| White | 37 | 42 | 79 |
| More than one race | 7 | 8 | 15 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Region of Enrollment(Participants) | Intervention | Control | Total |
|---|---|---|---|
| United States | 59 | 61 | 120 |
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Washington