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

NCT02651402 | Completed

• 2 other identifiers: 15-0123111R01MH108555-01
• Study Type: interventional
• Target: 495
• Locations: 1 country
• Sites: 1

Brief 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+).

Conditions

Anxiety Disorders

Keywords

Anxiety Disorders; Internalizing; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cost Effectiveness

  Duration of Project (5 years)

Other Outcomes (1)

• Implementation Fidelity: Train-the-Trainer (TT) to Train-the-Trainer Plus (TT+) for the implementation of aFRIENDS.

  Duration of Project (5 years)

Study Arms (3)

FRIENDS for Life Train-the-Trainer

ACTIVE COMPARATOR

Therapists implement FRIENDS (a CBT protocol for students with anxiety) in the school setting, while supported by their supervisor assigned to the Train-the-Trainer (TT) implementation strategy (supervisors participate in training workshops on conducting supervision with active therapists).

Behavioral: FRIENDS for Life; Behavioral: Train-the-Trainer

Adapted FRIENDS Train-the-Trainer

EXPERIMENTAL

Therapists implement an adapted version of FRIENDS (aFRIENDS) in the school setting while supported by their supervisor assigned to the TT strategy.

Behavioral: Adapted FRIENDS; Behavioral: Train-the-Trainer

Adapted FRIENDS Train-the-Trainer Plus

EXPERIMENTAL

Therapists implement aFRIENDS in the school setting while supported by their supervisor assigned to the Train-the-Trainer Plus (TT+) implementation strategy (supervisors participate in training workshops and receive further/on-going consultation on conducting supervision with active therapists).

Behavioral: Adapted FRIENDS; Behavioral: Train-the-Trainer Plus

Interventions

FRIENDS for Life BEHAVIORAL

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.

Also known as: FRIENDS

FRIENDS for Life Train-the-Trainer

Adapted FRIENDS BEHAVIORAL

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.

Also known as: aFRIENDS

Adapted FRIENDS Train-the-Trainer; Adapted FRIENDS Train-the-Trainer Plus

Train-the-Trainer BEHAVIORAL

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.

Also known as: TT

Adapted FRIENDS Train-the-Trainer; FRIENDS for Life Train-the-Trainer

Train-the-Trainer Plus BEHAVIORAL

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.

Also known as: TT+

Adapted FRIENDS Train-the-Trainer Plus

Eligibility Criteria

• Age: 8 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• University of Pennsylvania: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

• Eiraldi R, Lawson GM, Glick HA, Khanna MS, Beidas R, Fishman J, Rabenau-McDonnell Q, Wilson T, Comly R, Schwartz BS, Jawad AF. Implementation fidelity, student outcomes, and cost-effectiveness of train-the-trainer strategies for Masters-level therapists in urban schools: results from a cluster randomized trial. Implement Sci. 2024 Jan 25;19(1):4. doi: 10.1186/s13012-023-01333-9.

  PMID: 38273369 DERIVED

• Lawson GM, Comly R, Beidas RS, Khanna MS, Goldstein J, Brizzolara-Dove S, Wilson T, Rabenau-McDonnell Q, Eiraldi R. Therapist and supervisor perspectives about two train-the-trainer implementation strategies in schools: A qualitative study. Implement Res Pract. 2023 Aug 3;4:26334895231190854. doi: 10.1177/26334895231190854. eCollection 2023 Jan-Dec.

  PMID: 37790186 DERIVED

• Eiraldi R, Khanna MS, Jawad AF, Fishman J, Glick HA, Schwartz BS, Cacia J, Wandersman A, Beidas R. A hybrid effectiveness-implementation cluster randomized trial of group CBT for anxiety in urban schools: rationale, design, and methods. Implement Sci. 2016 Jul 12;11:92. doi: 10.1186/s13012-016-0453-z.

  PMID: 27405587 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Ricardo B Eiraldi, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2016
• First Posted: January 11, 2016
• Study Start: February 1, 2016
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)