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

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02651402
• Other study ID #: 15-012311
• Secondary ID: 1R01MH108555-01
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: February 28, 2021

Study information

• Verified date: April 2021
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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+).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 495
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	National Institute of Mental Health (NIMH), University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Implementation Fidelity: Train-the-Trainer (TT) to Train-the-Trainer Plus (TT+) for the implementation of aFRIENDS.	Using fidelity checklists, the ability of therapists to implement the interventions (as clinically intended), will be measured and compared across support implementation support strategies (TT vs. TT+).	Duration of Project (5 years)
Primary	Change in Manifest Anxiety Scale for Children (MASC) from Baseline to Post Intervention completed by parents and children	Effectiveness between treatment groups will be assessed by comparing the change in diagnostic status from pre to post intervention. Diagnostic status will be assessed using the Anxiety Disorders Interview Schedule for Children (ADIS-P) which includes a semi-structured interview used to determine diagnostic status and outcome. Clinical judgement is used to generate a Clinician Severity Rating (CSR). A CSR >4 is a clinical diagnosis of an anxiety disorder, CSR=3 patient at risk for developing a disorder.	Up to 12 weeks
Secondary	Cost Effectiveness	A Cost Benefit Analysis will be conducted across both interventions and implementation strategies, comparing material expenses, personnel effort, agency and school district salaries, etc.	Duration of Project (5 years)