A Hybrid Type 2 Trial of Trauma-Focused Cognitive Behavioral Therapy and a Pragmatic Individual-Level Implementation Strategy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

292 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-27

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This research project is a hybrid type 2 effectiveness-implementation trial that simultaneously examines (1) the effectiveness of a trauma-focused intervention for youth in the education sector and (2) the impact of a theory-driven pragmatic implementation strategy designed to increase the adoption, fidelity, and sustainment of evidence-based treatments (EBTs). This trial will include 120 clinicians and 480 students, and it is designed to test the cost effectiveness and impact of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) in a new setting that increases access to mental health care - schools (Aim 1); test the cost effectiveness, immediate impact, and sustained impact of the Beliefs and Attitudes for Successful Implementation in Schools (BASIS) implementation strategy on proximal mechanisms and implementation outcomes (Aims 2a, 2b, 2d); and conduct sequential mixed-methods data collection to explain residuals (i.e., clinicians whose implementation behavior is unaccounted for by the mediation model) (Aim 2c).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effectiveness of Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) for Children With Post-traumatic Stress Disorder (TreatChildTrauma)

NCT01516827

Post-Traumatic Stress Disorder

COMPLETED NA

Implementation of an Evidence Based Post-Traumatic Stress Disorder (PTSD) Treatment in Public Sector Settings

NCT01488539

Post-Traumatic Stress Disorder

COMPLETED NA

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

NCT02651402

Anxiety Disorders

COMPLETED NA

Systematic Redesign of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)

NCT06941428

Trauma, Psychological Trauma and Stressor Related Disorders

NOT_YET_RECRUITING NA

Neuromodulation and Neurorehabilitation for mTBI

NCT03819608

Mild Traumatic Brain Injury Post Traumatic Stress Disorder

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Evidence-Based Practices CBT School Health Services Trauma, Psychological

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Caregivers

The care provider is not masked to the intervention condition they are in (ie, TF-CBT vs TAU), but will be masked to the implementation strategy (ie, Attention Control vs. BASIS).

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BASIS with TF-CBT

Implementation intervention: experimental arm (Beliefs and Attitudes for Successful Implementation in Schools)

Clinical Intervention: experimental arm (Trauma-Focused CBT)

Group Type OTHER

Beliefs and Attitudes for Successful Implementation in Schools (BASIS)

Intervention Type BEHAVIORAL

BASIS blended (i.e., multifaceted and protocolized) implementation strategy, which occurs at the beginning of active implementation. BASIS is designed to facilitate observable implementation outcomes, including EBP adoption and intervention fidelity, via strategic education, motivational Interviewing, and social influence strategies.

Trauma-Focused Cognitive-Behavioral Therapy

Intervention Type BEHAVIORAL

TF-CBT is an evidence-based treatment that helps children from elementary to high school to address the negative effects of trauma and promote greater emotion and behavior regulation, including processing their traumatic memories, overcoming problematic thoughts and behaviors, and developing effective coping and interpersonal skills. It also includes a treatment component for parents or other caregivers. Parents can learn skills related to stress management, positive parenting, behavior management, and effective communication.

Attention Control (AC) with TF-CBT

Implementation intervention: control arm

Clinical Intervention: experimental arm (Trauma-Focused CBT)

Group Type OTHER

Trauma-Focused Cognitive-Behavioral Therapy

Intervention Type BEHAVIORAL

TF-CBT is an evidence-based treatment that helps children from elementary to high school to address the negative effects of trauma and promote greater emotion and behavior regulation, including processing their traumatic memories, overcoming problematic thoughts and behaviors, and developing effective coping and interpersonal skills. It also includes a treatment component for parents or other caregivers. Parents can learn skills related to stress management, positive parenting, behavior management, and effective communication.

Attention Control

Intervention Type BEHAVIORAL

Didactic presentation of implementation-related content (e.g., information about the importance of implementing, definitions of key terms, etc.) to control for facilitator, dose, information provided, and delivery platform

Enhanced Treatment as Usual

Implementation intervention: non-applicable

Clinical Intervention: control arm (Enhanced TAU)

Group Type OTHER

Treatment as Usual

Intervention Type BEHAVIORAL

Scaffolded intervention as usual. Includes: initial assessment of trauma symptoms, psychoeducation, follow-up planning and support.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Beliefs and Attitudes for Successful Implementation in Schools (BASIS)

BASIS blended (i.e., multifaceted and protocolized) implementation strategy, which occurs at the beginning of active implementation. BASIS is designed to facilitate observable implementation outcomes, including EBP adoption and intervention fidelity, via strategic education, motivational Interviewing, and social influence strategies.

Intervention Type BEHAVIORAL

Trauma-Focused Cognitive-Behavioral Therapy

TF-CBT is an evidence-based treatment that helps children from elementary to high school to address the negative effects of trauma and promote greater emotion and behavior regulation, including processing their traumatic memories, overcoming problematic thoughts and behaviors, and developing effective coping and interpersonal skills. It also includes a treatment component for parents or other caregivers. Parents can learn skills related to stress management, positive parenting, behavior management, and effective communication.

Intervention Type BEHAVIORAL

Treatment as Usual

Scaffolded intervention as usual. Includes: initial assessment of trauma symptoms, psychoeducation, follow-up planning and support.

Intervention Type BEHAVIORAL

Attention Control

Didactic presentation of implementation-related content (e.g., information about the importance of implementing, definitions of key terms, etc.) to control for facilitator, dose, information provided, and delivery platform

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Clinicians will be included if they (a) provide school-based services in a participating district; (b) have not previously received formal training in TF-CBT; and (c) are not actively receiving support to implement another trauma-focused intervention.

Students subjects will meet TF-CBT eligibility criteria, including (a) be within the TF-CBT developmental range (ages 8 to 19), (b) have traumatic event exposure (e.g., exposure to violence), and (c) significant post-traumatic stress symptoms.

Minimum Eligible Age

7 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes