Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2026-02-26 @ 2:16 AM
Study NCT ID:
NCT04451161
Status:
COMPLETED
Last Update Posted:
2025-09-12
First Post:
2020-06-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Hybrid Type 2 Trial of Trauma-Focused Cognitive Behavioral Therapy and a Pragmatic Individual-Level Implementation Strategy
Sponsor:
University of Washington
Organization:
Study Overview
Official Title:
A Hybrid Type 2 Trial of Trauma-Focused Cognitive Behavioral Therapy and a Pragmatic Individual-Level Implementation Strategy
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01MH119148-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |