Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies

Not Applicable

Completed

• Conditions: Psychological Trauma; Mental Health
• Interventions: Other: TF-CBT Learning Collaborative; Other: COAST-IS

• Registration Number: NCT03799432
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The purpose of this study is to partner with the North Carolina Child Treatment Program (NC CTP) and the SAMHSA-funded National Child Traumatic Stress Network (NCTSN) to develop and pilot the Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies (COAST-IS). The COAST-IS intervention will involve coaching organizational leaders and therapists to use Intervention Mapping to select and tailor strategies. Intervention Mapping is a multistep process that is inherently ecological and incorporates theory, evidence, and stakeholder perspectives to ensure that intervention components effectively address key determinants of change. After collaboratively developing COAST-IS in Year 1, the investigators will conduct a randomized pilot trial of the intervention within an NC CTP learning collaborative, randomly assigning eight organizations to the learning collaborative-only condition or the learning collaborative plus COAST-IS condition. Participants will include organizational leaders (e.g., CEOs/Directors, Clinical Directors, Supervisors) and therapists (e.g., Licensed Clinical Social Workers, Licensed Psychologists, Licensed Professional Counselors). The investigators will evaluate COAST-IS in the following aims: 1) to assess the acceptability, appropriateness, feasibility, and utility of COAST-IS; 2) to evaluate organizational stakeholders' fidelity to the core elements of Intervention Mapping; and 3) to demonstrate the feasibility of testing COAST-IS in a larger effectiveness trial. This work is significant because it will yield a systematic method that integrates theory, evidence, and stakeholder perspectives to improve the effectiveness and precision of implementation strategies. Ultimately, COAST-IS may have the potential to improve implementation and sustainment of a wide-range of EBPs in mental health and other health sectors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-09
• Study First Submitted QC: 2019-01-07
• Study First Posted: 2019-01-10
• Study Start: 2019-07-08
• Primary Completion: 2020-12-31
• Study Completion: 2021-09-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-25
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TF-CBT Learning collaborative	TF-CBT Learning Collaborative	Organizations will participate in a learning collaborative for implementing trauma-focused cognitive behavioral therapy (TF-CBT) with periodic coaching calls.
TF-CBT Learning collaborative + COAST-IS	TF-CBT Learning Collaborative	In addition to participating in a learning collaborative for implementing trauma-focused cognitive behavioral therapy (TF-CBT) with periodic coaching calls, organizations will receive additional training and tailored implementation support.
TF-CBT Learning collaborative + COAST-IS	COAST-IS	In addition to participating in a learning collaborative for implementing trauma-focused cognitive behavioral therapy (TF-CBT) with periodic coaching calls, organizations will receive additional training and tailored implementation support.

Primary Outcome Measures

Name	Time	Method
Evaluate the acceptability of COAST-IS	1 year	This will be assessed with the 4-item measure: Acceptability of Intervention. This measure is rated on a 5 point scale (completely disagree, disagree, neither agree nor disagree, agree, completely agree), with completely disagree having a score of 1 and completely agree having a score of 5. Higher scores indicate greater acceptability.
Evaluate the appropriateness of COAST-IS	1 year	This will be assessed with the 4-item measure: Intervention Appropriateness.This measure is rated on a 5 point scale (completely disagree, disagree, neither agree nor disagree, agree, completely agree), with completely disagree having a score of 1 and completely agree having a score of 5. Higher scores indicate greater appropriateness.
Evaluate the feasibility of COAST-IS	1 year	This will be assessed with the 4-item measure: Feasibility of Intervention.This measure is rated on a 5 point scale (completely disagree, disagree, neither agree nor disagree, agree, completely agree), with completely disagree having a score of 1 and completely agree having a score of 5. Higher scores indicate greater feasibility.
Evaluate the perceived utility of COAST-IS	1 year	Semi-structured interview will focus on the perceived utility of COAST-IS.
Fidelity to COAST-IS	1 year	Fidelity to COAST-IS will be measured with a fidelity assessment tool adapted from the Stages of Implementation Completion measure, which assesses organizations' progression through eight stages of implementation (engagement through competency \[conceptualized as the start of sustainment\]).

Secondary Outcome Measures

Name	Time	Method
Fidelity to TF-CBT	1 year	Therapist fidelity and adherence to TF-CBT will be assessed with the TF-CBT Fidelity Metric. This instrument consists of 12 scales (e.g., gradual exposure, cognitive processing) that allow a trainer to rate (on a 4-point scale) each TF-CBT component applied by a therapist within a session.

Trial Locations

Locations (1)

North Carolina Child Treatment Program; 🇺🇸 Durham, North Carolina, United States