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Trauma-Focused Cognitive Behavioral Therapy for Psychological Trauma

N/A

Recruiting

Led By Aaron Lyon, PhD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the effectiveness of a trauma-focused intervention called Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), as well as the impact of a theory-driven implementation strategy called Beliefs and Attitudes for Successful Implementation in Schools (BASIS). The trial will include 120 clinicians and 480 students, and will be designed to test the cost effectiveness and impact of TF-CBT in a new setting that increases access to mental health care - schools.

Who is the study for?

This trial is for school-based clinicians without prior TF-CBT training and students in grades 3-12 who have experienced trauma, like exposure to violence, and show significant stress symptoms. Clinicians already supporting another trauma-focused intervention or students outside the specified grade range cannot participate.

What is being tested?

The study tests Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) effectiveness in schools and evaluates a strategy called BASIS aimed at helping clinicians adopt and stick with evidence-based treatments. It involves 120 clinicians, 480 students, and looks into cost-effectiveness as well as long-term success.

What are the potential side effects?

Since this trial focuses on psychological therapy rather than medication, side effects are not typical in the same way they are with drugs. However, participants may experience emotional discomfort when discussing traumatic events during therapy sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Child PTSD Symptom Scale for DSM-V

Mood and Feelings Questionnaire - Short

TF-CBT Adoption

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Enhanced Treatment as UsualExperimental Treatment1 Intervention

Implementation intervention: non-applicable Clinical Intervention: control arm (Enhanced TAU)

Group II: BASIS with TF-CBTExperimental Treatment2 Interventions

Implementation intervention: experimental arm (Beliefs and Attitudes for Successful Implementation in Schools) Clinical Intervention: experimental arm (Trauma-Focused CBT)

Group III: AC with TF-CBTExperimental Treatment2 Interventions

Implementation intervention: control arm Clinical Intervention: experimental arm (Trauma-Focused CBT)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Attention Control

2014

Completed Phase 2

~6520

Treatment as Usual

2016