Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies (COAST-IS)
Primary Purpose
Psychological Trauma, Mental Health
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COAST-IS
TF-CBT Learning Collaborative
Sponsored by

About this trial
This is an interventional health services research trial for Psychological Trauma focused on measuring Implementation Science, Cognitive Behavioral Therapy, Children, Youth
Eligibility Criteria
- Employed at an organization participating in a North Carolina Child Treatment Program TF-CBT learning collaborative
- Working as an organizational leader (e.g., senior leaders and clinical supervisors) or therapist
- Direct involvement in the organization's implementation of TF-CBT
Sites / Locations
- North Carolina Child Treatment Program
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TF-CBT Learning collaborative + COAST-IS
TF-CBT Learning collaborative
Arm Description
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.
Organizations will participate in a learning collaborative for implementing trauma-focused cognitive behavioral therapy (TF-CBT) with periodic coaching calls.
Outcomes
Primary Outcome Measures
Evaluate the acceptability of COAST-IS
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
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
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
Semi-structured interview will focus on the perceived utility of COAST-IS.
Fidelity to COAST-IS
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
Fidelity to TF-CBT
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.
Fidelity to TF-CBT
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.
Full Information
NCT ID
NCT03799432
First Posted
December 9, 2018
Last Updated
April 25, 2022
Sponsor
Washington University School of Medicine
Collaborators
National Institute of Mental Health (NIMH), North Carolina Child Treatment Program, National Child Traumatic Stress Network, UCLA-Duke National Center for Child Traumatic Stress
1. Study Identification
Unique Protocol Identification Number
NCT03799432
Brief Title
Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies
Acronym
COAST-IS
Official Title
Improving the Implementation and Sustainment of Evidenced Based Practices in Mental Health: Developing and Piloting the Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
July 8, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institute of Mental Health (NIMH), North Carolina Child Treatment Program, National Child Traumatic Stress Network, UCLA-Duke National Center for Child Traumatic Stress
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Trauma, Mental Health
Keywords
Implementation Science, Cognitive Behavioral Therapy, Children, Youth
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TF-CBT Learning collaborative + COAST-IS
Arm Type
Experimental
Arm Description
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.
Arm Title
TF-CBT Learning collaborative
Arm Type
Active Comparator
Arm Description
Organizations will participate in a learning collaborative for implementing trauma-focused cognitive behavioral therapy (TF-CBT) with periodic coaching calls.
Intervention Type
Other
Intervention Name(s)
COAST-IS
Intervention Description
COAST-IS has been designed to equip organizations with the knowledge, motivation, and skill needed to thoughtfully match implementation strategies to identified determinants by applying intervention mapping. The COAST-IS intervention will include four different modes of delivery: 1) dissemination of educational materials; 2) five web-based interactive education sessions on the need for tailoring implementation strategies and the application of intervention mapping; 3) site visits to discuss change objectives necessary to successfully implement trauma-focused cognitive behavioral therapy; and 4) organizational coaching related to using an intervention mapping approach.
Intervention Type
Other
Intervention Name(s)
TF-CBT Learning Collaborative
Intervention Description
The learning collaborative model was adapted from the Breakthrough Series Collaborative model. Leadership of the collaboratives includes experts in evidence-based practices, implementation, and quality improvement. Main components include: 1) three face-to-face learning sessions (2-days each) that provide clinical training; 2) post-learning session action periods structured to facilitate therapists' application of learned skills; 3) a secure website to facilitate faculty-to-participant and peer-to-peer learning and document use of quality improvement methods; 4) fidelity monitoring and coaching; 5) a senior leader track supporting organizational change; 6) monthly outcomes monitoring; and 7) sustainability planning.
Primary Outcome Measure Information:
Title
Evaluate the acceptability of COAST-IS
Description
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.
Time Frame
1 year
Title
Evaluate the appropriateness of COAST-IS
Description
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.
Time Frame
1 year
Title
Evaluate the feasibility of COAST-IS
Description
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.
Time Frame
1 year
Title
Evaluate the perceived utility of COAST-IS
Description
Semi-structured interview will focus on the perceived utility of COAST-IS.
Time Frame
1 year
Title
Fidelity to COAST-IS
Description
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]).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Fidelity to TF-CBT
Description
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.
Time Frame
6 months
Title
Fidelity to TF-CBT
Description
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.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Organizational Readiness for Implementing Change (ORIC)
Description
The 12 items comprising the ORIC measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure assesses whether members of an organization, collectively, are (1) committed to implementing a new practice or process and (2) believe that they have the capacity to do so. For these two subscales and the overall ORIC scale, organizations receive scores between 1 and 5 (higher scores are considered more positive).
Time Frame
Baseline, 1 year
Title
Evidence-based Practice Attitudes Scales (EBPAS)
Description
The 15 items comprising the EBPAS measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure articulates practitioner willingness to adopt new interventions as a function of four factors: (1) appeal of the new intervention, (2) organizational requirements, (3) practitioner openness, and (4) divergence (perceived incompatibility with practice or limited usefulness of research-based interventions). For these four subscales and the overall EBPAS scale, organizations receive scores between 0 and 4 (higher scores are considered more positive).
Time Frame
Baseline, 1 year
Title
Inner Setting of the Consolidated Framework for Implementation Research
Description
This questionnaire assesses factors related to the inner setting of organizations that are believed to be important in influencing the implementation of interventions. Thirty items from this questionnaire will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. These items measure three factors: (1) culture, (2) learning climate, and (3) available resources. Organizations receive scores between 1 and 5 for each of these factors (higher scores are considered more positive).
Time Frame
Baseline, 1 year
Title
Scale for Implementation Climate
Description
The six items comprising this measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure assesses whether organizations are primed for implementation via three factors: the extent to which employees believe implementation is (1) expected, (2) supported, and (3) rewarded. For these three subscales and the overall ICS scale, organizations receive scores between 1 and 5 (higher scores are considered more positive).
Time Frame
Baseline, 1 year
Title
Psychological Safety Scale (PSS)
Description
The seven items comprising the PSS measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure assesses how much the environment of a work team makes members feel they can safely engage in learning behavior (e.g., seeking feedback, discussing errors, asking questions, experimenting) without great risk of losing face. Organizations receive a score between 1 and 7 for this scale (higher scores are considered more positive).
Time Frame
Baseline, 1 year
Title
Implementation Leadership Scale (ILS)
Description
The 12 items comprising the ILS measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure assesses whether leadership is proactive, knowledgeable, supportive, and perseverant based on specific actions leaders take in promoting implementation. For these four subscales and the overall ILS scale, organizations receive scores between 0 and 4 (higher scores are considered more positive).
Time Frame
Baseline, 1 year
Title
Implementation Citizenship Behavior Scale (ICBS)
Description
The six items comprising the ICBS measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure assesses two critical employee behaviors that go beyond what is required to support the implementation of evidence-based practices: (1) helping their peers with implementation-related activities and (2) keeping informed about issues related to evidence-based practice and implementation efforts. For these two subscales and the overall ICBS scale, organizations receive scores between 0 and 4 (higher scores are considered more positive).
Time Frame
Baseline, 1 year
Title
Prior Experiences with Implementation
Description
This questionnaire assesses employees' experiences and judgments toward previous innovation implementation, which may affect their implementation behavior regarding future innovations. Sixteen items from this questionnaire will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. These items measure four subscales: (1) perceived intensity of previous innovations, (2) perceived failure of previous innovations, (3) innovation-targeted helplessness, and (4) innovation fatigue. Organizations receive scores between 1 and 5 for each of these subscales (higher scores are considered more negative).
Time Frame
Baseline, 1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Employed at an organization participating in a North Carolina Child Treatment Program TF-CBT learning collaborative
Working as an organizational leader (e.g., senior leaders and clinical supervisors) or therapist
Direct involvement in the organization's implementation of TF-CBT
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byron J Powell, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Carolina Child Treatment Program
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32391524
Citation
Powell BJ, Haley AD, Patel SV, Amaya-Jackson L, Glienke B, Blythe M, Lengnick-Hall R, McCrary S, Beidas RS, Lewis CC, Aarons GA, Wells KB, Saldana L, McKay MM, Weinberger M. Improving the implementation and sustainment of evidence-based practices in community mental health organizations: a study protocol for a matched-pair cluster randomized pilot study of the Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies (COAST-IS). Implement Sci Commun. 2020;1:9. doi: 10.1186/s43058-020-00009-5. Epub 2020 Feb 25.
Results Reference
derived
Learn more about this trial
Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies
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