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      Study protocol: cluster randomized trial of consultation strategies for the sustainment of mental health interventions in under-resourced urban schools: rationale, design, and methods

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          Abstract

          Background

          The school is a key setting for the provision of mental health services to children, particularly those underserved through traditional service delivery systems. School-wide Positive Behavioral Interventions and Supports (PBIS) is a tiered approach to service delivery based on the public health model that schools use to implement universal (Tier 1) supports to improve school climate and safety. As our prior research has demonstrated, PBIS is a useful vehicle for implementing mental and behavioral health evidence-based practices (EBPs) at Tier 2 for children with, or at risk for, mental health disorders. Very little research has been conducted regarding the use of mental health EBPs at Tier 2 or how to sustain implementation in schools.

          Methods/design

          The main aim of the study is to compare fidelity, penetration, cost-effectiveness, and student outcomes of Tier 2 mental health interventions across 2 sustainment approaches for school implementers in 12 K-8 schools. The study uses a 2-arm, cluster randomized controlled trial design. The two arms are: (a) Preparing for Sustainment (PS)—a consultation strategy implemented by school district coaches who receive support from external consultants, and (b) Sustainment as Usual (SAU)—a consultation strategy implemented by school district coaches alone. Participants will be 60 implementers and 360 students at risk for externalizing and anxiety disorders. The interventions implemented by school personnel are: Coping Power Program (CPP) for externalizing disorders, CBT for Anxiety Treatment in Schools (CATS) for anxiety disorders, and Check-in/Check-out (CICO) for externalizing and internalizing disorders. The Interactive Systems Framework (ISF) for Dissemination and Implementation guides the training and support procedures for implementers.

          Discussion

          We expect that this study will result in a feasible, effective, and cost-effective strategy for sustaining mental health EBPs that is embedded within a multi-tiered system of support. Results from this study conducted in a large urban school district would likely generalize to other large, urban districts and have an impact on population-level child mental health.

          Trial registration ClinicalTrials.gov identifier number NCT04869657. Registered May 3, 2021.

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          Most cited references60

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          Outcomes for Implementation Research: Conceptual Distinctions, Measurement Challenges, and Research Agenda

          An unresolved issue in the field of implementation research is how to conceptualize and evaluate successful implementation. This paper advances the concept of “implementation outcomes” distinct from service system and clinical treatment outcomes. This paper proposes a heuristic, working “taxonomy” of eight conceptually distinct implementation outcomes—acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, penetration, and sustainability—along with their nominal definitions. We propose a two-pronged agenda for research on implementation outcomes. Conceptualizing and measuring implementation outcomes will advance understanding of implementation processes, enhance efficiency in implementation research, and pave the way for studies of the comparative effectiveness of implementation strategies.
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            Psychometric assessment of three newly developed implementation outcome measures

            Background Implementation outcome measures are essential for monitoring and evaluating the success of implementation efforts. Yet, currently available measures lack conceptual clarity and have largely unknown reliability and validity. This study developed and psychometrically assessed three new measures: the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). Methods Thirty-six implementation scientists and 27 mental health professionals assigned 31 items to the constructs and rated their confidence in their assignments. The Wilcoxon one-sample signed rank test was used to assess substantive and discriminant content validity. Exploratory and confirmatory factor analysis (EFA and CFA) and Cronbach alphas were used to assess the validity of the conceptual model. Three hundred twenty-six mental health counselors read one of six randomly assigned vignettes depicting a therapist contemplating adopting an evidence-based practice (EBP). Participants used 15 items to rate the therapist’s perceptions of the acceptability, appropriateness, and feasibility of adopting the EBP. CFA and Cronbach alphas were used to refine the scales, assess structural validity, and assess reliability. Analysis of variance (ANOVA) was used to assess known-groups validity. Finally, half of the counselors were randomly assigned to receive the same vignette and the other half the opposite vignette; and all were asked to re-rate acceptability, appropriateness, and feasibility. Pearson correlation coefficients were used to assess test-retest reliability and linear regression to assess sensitivity to change. Results All but five items exhibited substantive and discriminant content validity. A trimmed CFA with five items per construct exhibited acceptable model fit (CFI = 0.98, RMSEA = 0.08) and high factor loadings (0.79 to 0.94). The alphas for 5-item scales were between 0.87 and 0.89. Scale refinement based on measure-specific CFAs and Cronbach alphas using vignette data produced 4-item scales (α’s from 0.85 to 0.91). A three-factor CFA exhibited acceptable fit (CFI = 0.96, RMSEA = 0.08) and high factor loadings (0.75 to 0.89), indicating structural validity. ANOVA showed significant main effects, indicating known-groups validity. Test-retest reliability coefficients ranged from 0.73 to 0.88. Regression analysis indicated each measure was sensitive to change in both directions. Conclusions The AIM, IAM, and FIM demonstrate promising psychometric properties. Predictive validity assessment is planned. Electronic supplementary material The online version of this article (doi:10.1186/s13012-017-0635-3) contains supplementary material, which is available to authorized users.
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              Implementation matters: a review of research on the influence of implementation on program outcomes and the factors affecting implementation.

              The first purpose of this review was to assess the impact of implementation on program outcomes, and the second purpose was to identify factors affecting the implementation process. Results from over quantitative 500 studies offered strong empirical support to the conclusion that the level of implementation affects the outcomes obtained in promotion and prevention programs. Findings from 81 additional reports indicate there are at least 23 contextual factors that influence implementation. The implementation process is affected by variables related to communities, providers and innovations, and aspects of the prevention delivery system (i.e., organizational functioning) and the prevention support system (i.e., training and technical assistance). The collection of implementation data is an essential feature of program evaluations, and more information is needed on which and how various factors influence implementation in different community settings.
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                Author and article information

                Contributors
                eiraldi@upenn.edu
                Journal
                BMC Psychol
                BMC Psychol
                BMC Psychology
                BioMed Central (London )
                2050-7283
                7 February 2022
                7 February 2022
                2022
                : 10
                : 24
                Affiliations
                [1 ]GRID grid.239552.a, ISNI 0000 0001 0680 8770, Children’s Hospital of Philadelphia, , Roberts Center for Pediatric Research, ; 2716 South Street, Room 8293, Philadelphia, PA 19146-2305 USA
                [2 ]GRID grid.25879.31, ISNI 0000 0004 1936 8972, Department of Pediatrics, , University of Pennsylvania Perelman School of Medicine, ; 3400 Civic Center Boulevard, Philadelphia, PA 19104 USA
                [3 ]GRID grid.282356.8, ISNI 0000 0001 0090 6847, Philadelphia College of Osteopathic Medicine, ; 4170 City Avenue, Philadelphia, PA 19131 USA
                [4 ]OCD and Anxiety Institute, 3138 Butler Pike # 200, Plymouth Meeting, PA 19462 USA
                [5 ]GRID grid.25879.31, ISNI 0000 0004 1936 8972, Department of Psychiatry, , University of Pennsylvania Perelman School of Medicine, ; 3535 Market St., Philadelphia, PA 19104 USA
                [6 ]GRID grid.25879.31, ISNI 0000 0004 1936 8972, Leonard Davis Institute of Health Economics, , University of Pennsylvania, ; 3641 Locus Walk # 210, Philadelphia, PA 19104 USA
                [7 ]GRID grid.25879.31, ISNI 0000 0004 1936 8972, Wharton School, , University of Pennsylvania, ; 3620 Locust Walk, Philadelphia, PA 19104 USA
                [8 ]GRID grid.454404.5, Devereux Center for Effective Schools, ; 2012 Renaissance, Blvd., King of Prussia, PA 19406 USA
                [9 ]GRID grid.429862.3, ISNI 0000 0004 0451 1895, School District of Philadelphia, ; 440 North Broad Street, Philadelphia, PA 19130 USA
                [10 ]GRID grid.254567.7, ISNI 0000 0000 9075 106X, Department of Psychology, , University of South Carolina-Columbia, ; Pendleton Street, Barnwell College, Suite #220, Columbia, SC 29208 USA
                Author information
                http://orcid.org/0000-0003-3997-696X
                Article
                733
                10.1186/s40359-022-00733-8
                8822800
                35130964
                46e4cce6-9273-4589-a0be-09f2e2b91350
                © The Author(s) 2022

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 8 December 2021
                : 28 January 2022
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100000025, National Institute of Mental Health;
                Award ID: 1R01MH122465-01A1
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2022

                sustainment,implementation,pbis,mental health supports,urban schools,effectiveness

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