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



Status:Recruiting
Conditions:Anxiety
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:8 - 99
Updated:1/10/2019
Start Date:February 2016
End Date:November 2020
Contact:Jaclyn Cacia, MS
Email:caciaj@email.chop.edu
Phone:267-426-6015

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

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+).

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.

Inclusion Criteria:

1. Supervisors: Any participating agency clinical supervisor with a Master's degree or
higher in a mental health field.

2. Therapists: Any STS therapist with a Bachelor's degree or higher who provides services
in one of the 18 participating schools.

3. Students: Any student enrolled in grades 4-8 in one of the participating schools, who
had been referred to the STS program in their school and who meets study screening and
diagnostic criteria. The screening criterion is a Total score > 25 on Screen for Child
Anxiety Related Disorders (SCARED) completed by a parent or school staff member. This
student must also present a primary positive or intermediate diagnosis of Separation
Anxiety Disorder (SAD]) Generalized Anxiety Disorder (GAD), or Social Phobia (SP) on
the Anxiety Disorders Interview Schedule (ADIS); completed by a parent during the
eligibility evaluation.

4. If, at the conclusion of the eligibility evaluation, students do not meet diagnostic
criteria (see above) to participate in the study, but parents and school staff
continue to express concern about functional impairment, students will be permitted to
participate in the intervention sessions (with parent permission). We also expect that
there might be a very small number of eligible children whose parents may not give
consent, and some of these parents and school personnel might want these children to
benefit from the intervention. As such, we would like to offer these children the
opportunity to participate along with the research subjects. This group of students
will not be identified as "research subjects" and study data will not be collected
from them. However, parents will be asked to sign a permission form for the video
recording of the group sessions. This is the procedure we currently follow for our
National Institute of Child Health and Human Development (NICHD) funded project, which
has been approved by the Institutional Review Board (IRB) of The Children's Hospital
of Philadelphia and School District of Philadelphia.

Exclusion Criteria:

1. Supervisors or therapists not involved in STS.

2. Students with Special Education classification of "Intellectual Disability;" children
whose primary diagnosis is not SAD, GAS or SP.

3. Students with a history of psychotic or autistic spectrum disorders according to
school records.

- Students meeting criteria in #2 & #3 above will be excluded from participation
because they would be unlikely to benefit from Global Cognitive Behavioral
Therapy (GCBTS).

Subjects that do not meet all of the enrollment criteria may not be enrolled. Any
violations of these criteria must be reported in accordance with IRB Policies and
Procedures.
We found this trial at
1
site
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Ricardo Eiraldi, MD
Phone: 267-426-6015
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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