Clinical trial NCT03799432: Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies
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
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Trauma
Mental Health
Keywords: Implementation Science
Cognitive Behavioral Therapy
Children
Youth
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: North Carolina Child Treatment Program
name: National Child Traumatic Stress Network
name: UCLA-Duke National Center for Child Traumatic Stress
First posted: 2019-01-10
Enrollment: 62
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Evaluate the acceptability of COAST-IS
timeFrame: 1 year
measure: Evaluate the appropriateness of COAST-IS
timeFrame: 1 year
measure: Evaluate the feasibility of COAST-IS
timeFrame: 1 year
measure: Evaluate the perceived utility of COAST-IS
timeFrame: 1 year
measure: Fidelity to COAST-IS
timeFrame: 1 year
Secondary outcomes:
measure: Fidelity to TF-CBT
timeFrame: 6 months
measure: Fidelity to TF-CBT
timeFrame: 1 year
Other outcomes:
measure: Organizational Readiness for Implementing Change (ORIC)
timeFrame: Baseline, 1 year
measure: Evidence-based Practice Attitudes Scales (EBPAS)
timeFrame: Baseline, 1 year
measure: Inner Setting of the Consolidated Framework for Implementation Research
timeFrame: Baseline, 1 year
measure: Scale for Implementation Climate
timeFrame: Baseline, 1 year
measure: Psychological Safety Scale (PSS)
timeFrame: Baseline, 1 year
measure: Implementation Leadership Scale (ILS)
timeFrame: Baseline, 1 year
measure: Implementation Citizenship Behavior Scale (ICBS)
timeFrame: Baseline, 1 year
measure: Prior Experiences with Implementation
timeFrame: Baseline, 1 year
Locations:
city: Durham
country: United States
facility: North Carolina Child Treatment Program
state: North Carolina
Study officials:
affiliation: Washington University School of Medicine
name: Byron J Powell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.