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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH108555-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Ricardo B Eiraldi, PhD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38273369 | Derived | 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. | |
| 37790186 | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 5, 2018 | Dec 6, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
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| D001008 | Anxiety Disorders |
| ID | Term |
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| D001523 | Mental Disorders |
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| 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. |
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| 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. |
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| 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. |
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| 27405587 | 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. |