NCT02651402

A Hybrid Effectiveness-Implementation Trial of Group CBT in Urban Schools

A Hybrid Effectiveness-Implementation Trial of Group Cognitive Behavior Therapy (CBT) in Urban Schools

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 495 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 8 Years – 99 Years
• Healthy volunteers: Accepted

Summary

Unresolved psychological problems, such as anxiety, affect a significant number of our students and interfere with their ability to attend, actively participate, and prosper in school. This project will expand the capacity of selected mental health agencies to provide services in the participating schools through school therapeutic services (STS). The project will provide enhanced training in evidence-based behavioral health interventions to school-based mental health providers. The services will be implemented by STS Bachelor's or Master's level therapists supervised by their mental health agency supervisors (Internal Support), who are in turn supported by the research team (Train-the-Trainer) or external consultants (Train the Trainer+).

Detailed description

Background/Purpose: This project will expand the capacity of selected mental health agencies to provide services in the participating schools through school therapeutic services (STS). The project will provide enhanced training in evidence-based behavioral health interventions to school-based mental health providers. The services will be implemented by STS Master's level therapists supervised by their mental health agency supervisors (Internal Support), who are in turn supported by the research team (TT) or external consultants (TT+). Population: 18 schools in Philadelphia will be chosen for participation. Students who present excessive anxiety in grades 4-8 would be potentially eligible to participate in the interventions offered by the agencies' therapists in their school. Intervention: This study is designed to test: a) the effectiveness of an adapted version of a group cognitive behavioral therapy program (aFRIENDS) compared to the original version of this program (FRIENDS), and b) the effectiveness of two implementation support strategies for aFRIENDS: Train-the-Trainer and Train-the-Trainer Plus. aFRIENDS is a shorter, more culturally sensitive, focused, and feasible CBT for anxiety in children than FRIENDS and addresses one of the major barriers to implementation (intervention-context fit). Design: Therapists and supervisors will be randomly assigned to one of three conditions: a) FRIENDS with Train-the-Trainer implementation strategy (i.e., Masters-level supervisors receive training by experts on conducting supervision); b) aFRIENDS with Train-the-Trainer strategy; c) aFRIENDS using the Train-the-Trainer Plus strategy (i.e., supervisors receive training and consultation by experts on conducting supervision). Analyses: Effectiveness will be measured by comparing A to B; Implementation will be measured by comparing B to C. Agency therapists will conduct all treatment groups in the schools.

Conditions

• Anxiety Disorders

Interventions

Type	Name	Description
BEHAVIORAL	FRIENDS for Life	Friends for Life (FRIENDS): FRIENDS, a GCBT program, is an effective program for the prevention and treatment of anxiety disorders in children evidenced by a meta-analysis on school-based interventions for at-risk and clinically anxious youth. FRIENDS was developed based on the view that anxiety is a tripartite construct involving physiological, cognitive, and behavioral components. Core Intervention components: Experts in CBT for childhood anxiety disorders have identified 5 essential components: psychoeducation, somatic management skills training, cognitive restructuring, exposure methods, and contingency management. The FRIENDS protocol consists of 10 weekly sessions and two booster sessions. We included the booster sessions in the regular protocol for a total of 12 sessions.
BEHAVIORAL	Adapted FRIENDS	Adapted Friends (aFRIENDS): We conducted planned adaptations to the FRIENDS protocol based on our collective experience with the protocol and qualitative data (focus group and interviews). We followed procedures developed by Lee and colleagues, including surveying service providers and trainers regarding the appropriateness of FRIENDS for the target population. Changes were made to the language (idioms, metaphors, words), cultural fit (cultural values), methods (session length, number of sessions), activities (in-session practices), which resulted in additions and substitutions in these areas while maintaining the 5 essential components of the treatment. aFRIENDS is a briefer (8-session) and more engaging and culturally-sensitive protocol than FRIENDS.
BEHAVIORAL	Train-the-Trainer	Train the Trainer (TT): agency supervisors are trained to conduct effective supervision (one initial training and 2 booster sessions), and then go on to train intervention therapists.
BEHAVIORAL	Train-the-Trainer Plus	Train the Trainer Plus (TT+): a modified train-the-trainer approach by which supervisors receive training plus extended on-going consultation on conducting effective supervision with intervention therapists.

Timeline

• Start date: 2016-02-01
• Primary completion: 2021-02-28
• Completion: 2021-02-28
• First posted: 2016-01-11
• Last updated: 2021-04-08

Locations

1 site across 1 country: United States