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

Completed · Not applicable

Conditions studied: Anxiety Disorders

In brief

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+).

Key facts

Study ID

NCT02651402

Run by

Children's Hospital of Philadelphia

People needed

495

Starts

2016-02-01

Expected to finish

2021-02-28

Last updated by the study team

2021-04-08

Who can join

Age: 8 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Supervisors: Any participating agency clinical supervisor with a Master's degree or higher in a mental health field.
• Therapists: Any STS therapist with a Bachelor's degree or higher who provides services in one of the 18 participating schools.
• 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.
• 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.

You may not qualify if…

• Supervisors or therapists not involved in STS.
• Students with Special Education classification of "Intellectual Disability;" children whose primary diagnosis is not SAD, GAS or SP.
• 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.

Where it is running

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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