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

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

 

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.

 

Eligibility

Ages Eligible for Study:  

8 Years to 99 Years   (Child, Adult, Senior)

Sexes Eligible for Study:  

All

Accepts Healthy Volunteers:  

Yes

 

Criteria

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.

o    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.

 

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies. 

Please refer to this study by its ClinicalTrials.gov identifier: NCT02651402
 

Contacts

Contact: Jaclyn Cacia, MS

267-426-6015

caciaj@email.chop.edu

Contact: Billie S Schwartz, PhD

267-426-2868

schwartzb@email.chop.edu

 

Locations

United States, Pennsylvania

Children's Hospital of Philadelphia

Recruiting

Philadelphia, PennsylvaniaUnited States, 19104

Contact: Jaclyn Cacia, MS    267-426-6015   

caciaj@email.chop.edu   

Principal Investigator: Ricardo Eiraldi, MD         

 

Sponsors and Collaborators

Children's Hospital of Philadelphia

University of Pennsylvania

National Institute of Mental Health (NIMH)

 

Investigators

Principal Investigator: Ricardo B Eiraldi, PhD

Children's Hospital of Philadelphia