NCT00619255: ATRSCC

Adolescent Trauma Recovery and Stress Disorders Collaborative Care (ATRSCC) Model Program Trial

Completed NA Results posted Last updated 19 February 2018

What this trial tests

NA trial testing Adolescent Trauma Support Program in Post-traumatic Stress Disorder in 120 participants. Completed in 1 June 2014.

Timeline

1 March 2008

Primary endpoint
31 October 2010

1 June 2014

Quick facts

Lead sponsor	University of Washington
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	120
Start date	1 March 2008
Primary completion	31 October 2010
Estimated completion	1 June 2014
Sites	1 location across United States

Drugs / interventions tested

• Adolescent Trauma Support Program

Conditions studied

• Post-traumatic Stress Disorder — all drugs for Post-traumatic Stress Disorder →
• Alcohol Abuse — all drugs for Alcohol Abuse →
• Alcohol Dependence — all drugs for Alcohol Dependence →

Sponsor

University of Washington

Who can join

Adults 12 to 18, any sex, with Post-traumatic Stress Disorder or Alcohol Abuse. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients With High Levels of Adolescent PTSD Symptoms Primary · Baseline (injury), then 2, 5, and 12 months post-injury

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.

Baseline

Group	Value	95% CI
Intervention	9
Control	12

2-months

Group	Value	95% CI
Intervention	11
Control	12

5-months

Group	Value	95% CI
Intervention	9
Control	13

12-months

Group	Value	95% CI
Intervention	12
Control	9

Number of Patients Who Self-reported Alcohol Consumption or Drug Use Secondary · Baseline (injury), and 2, 5, and 12 months post-injury

Any self-reported alcohol or drug use using one yes or no question

Baseline

Group	Value	95% CI
Intervention	28
Control	25

2-months

Group	Value	95% CI
Intervention	18
Control	14

5-months

Group	Value	95% CI
Intervention	19
Control	21

12-months

Group	Value	95% CI
Intervention	22
Control	26

Percentage of Asolescents Linked to Primary Care During the Study Secondary · Up to12 months post-injury

Percentage of adolescents self-reporting one or more primary care visits over the course of the 12-months after the injury

Group	Value	95% CI
Intervention	43
Control	48

Percentage of Adolescents Who Self-reported Weapon Carriage Secondary · Baseline (injury), then 2, 5, and 12 months post-injury

Self-reported carrying of knife, gun, club or other weapon by adolescent

Baseline

Group	Value	95% CI
Intervention	20
Control	19

2-months

Group	Value	95% CI
Intervention	8
Control	15

5-months

Group	Value	95% CI
Intervention	5
Control	13

12-months

Group	Value	95% CI
Intervention	4
Control	13

Number of Patients Experiencing High-Level Depressive Symptoms Secondary · Baseline (injury), then 2, 5, and 12 months post-injury

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.

Baseline

Group	Value	95% CI
Intervention	4
Control	8

2-months

Group	Value	95% CI
Intervention	3
Control	4

5-months

Group	Value	95% CI
Intervention	2
Control	4

12-months

Group	Value	95% CI
Intervention	7
Control	6

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention

Serious: 0/59 (0%)

Deaths: 0/59

Control

Serious: 0/61 (0%)

Deaths: 0/61

Other adverse events (1 terms — click to expand)

Reaction	System	Intervention	Control
Suicide ideation	Psychiatric disorders	—	—

Data from ClinicalTrials.gov NCT00619255 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Collaborative care intervention targeting violence risk behaviors, substance use, and posttraumatic stress and depressive symptoms in injured adolescents: a randomized clinical trial.
   Zatzick D, Russo J, Lord SP, Varley C, et al · · 2014 · cited 77× · PMID 24733515 · DOI 10.1001/jamapediatrics.2013.4784