Protocol for a statewide randomized controlled trial to compare three training models for implementing an evidence-based treatment

Implementation Science, Sep 2015

Background Evidence-based treatments (EBTs) are available for treating childhood behavioral health challenges. Despite EBTs’ potential to help children and families, they have primarily remained in university settings. Little empirical evidence exists regarding how specific, commonly used training and quality control models are effective in changing practice, achieving full implementation, and supporting positive client outcomes. Methods/design This study (NIMH RO1 MH095750; ClinicalTrials.gov Identifier: NCT02543359), which is currently in progress, will evaluate the effectiveness of three training models (Learning Collaborative (LC), Cascading Model (CM), and Distance Education (DE)) to implement a well-established EBT , Parent-Child Interaction Therapy, in real-world, community settings. The three models differ in their costs, skill training, quality control methods, and capacity to address broader implementation challenges. The project is guided by three specific aims: (1) to build knowledge about training outcomes, (2) to build knowledge about implementation outcomes, and (3) to test the differential impact of training clinicians using LC, CM, and DE models on key client outcomes. Fifty (50) licensed psychiatric clinics across Pennsylvania were randomized to one of the three training conditions: (1) LC, (2) CM, or (3) DE. The impact of training on practice skills (clinician level) and implementation/sustainment outcomes (clinic level) are being evaluated at four timepoints coinciding with the training schedule: baseline, 6 (mid), 12 (post), and 24 months (1 year follow-up). Immediately after training begins, parent–child dyads (client level) are recruited from the caseloads of participating clinicians. Client outcomes are being assessed at four timepoints (pre-treatment, 1, 6, and 12 months after the pre-treatment). Discussion This proposal builds on an ongoing initiative to implement an EBT statewide. A team of diverse stakeholders including state policy makers, payers, consumers, service providers, and academics from different, but complementary areas (e.g., public health, social work, psychiatry), has been assembled to guide the research plan by incorporating input from multidimensional perspective. Trial registration ClinicalTrials.gov: NCT02543359

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Protocol for a statewide randomized controlled trial to compare three training models for implementing an evidence-based treatment

Herschell et al. Implementation Science Protocol for a statewide randomized controlled trial to compare three training models for implementing an evidence-based treatment Amy D. Herschell 0 1 2 David J. Kolko 1 2 Ashley T. Scudder 1 2 Sarah Taber-Thomas 1 2 Kristen F. Schaffner 2 Shelley A. Hiegel 2 Satish Iyengar 2 Mark Chaffin 2 Stanley Mrozowski 2 0 Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine , Pittsburgh, PA , USA 1 University of Pittsburgh School of Medicine , Pittsburgh, PA , USA 2 Completed by the trainer on clinicians Background: Evidence-based treatments (EBTs) are available for treating childhood behavioral health challenges. Despite EBTs' potential to help children and families, they have primarily remained in university settings. Little empirical evidence exists regarding how specific, commonly used training and quality control models are effective in changing practice, achieving full implementation, and supporting positive client outcomes. Methods/design: This study (NIMH RO1 MH095750; ClinicalTrials.gov Identifier: NCT02543359), which is currently in progress, will evaluate the effectiveness of three training models (Learning Collaborative (LC), Cascading Model (CM), and Distance Education (DE)) to implement a well-established EBT , Parent-Child Interaction Therapy, in real-world, community settings. The three models differ in their costs, skill training, quality control methods, and capacity to address broader implementation challenges. The project is guided by three specific aims: (1) to build knowledge about training outcomes, (2) to build knowledge about implementation outcomes, and (3) to test the differential impact of training clinicians using LC, CM, and DE models on key client outcomes. Fifty (50) licensed psychiatric clinics across Pennsylvania were randomized to one of the three training conditions: (1) LC, (2) CM, or (3) DE. The impact of training on practice skills (clinician level) and implementation/sustainment outcomes (clinic level) are being evaluated at four timepoints coinciding with the training schedule: baseline, 6 (mid), 12 (post), and 24 months (1 year follow-up). Immediately after training begins, parent-child dyads (client level) are recruited from the caseloads of participating clinicians. Client outcomes are being assessed at four timepoints (pre-treatment, 1, 6, and 12 months after the pre-treatment). Discussion: This proposal builds on an ongoing initiative to implement an EBT statewide. A team of diverse stakeholders including state policy makers, payers, consumers, service providers, and academics from different, but complementary areas (e.g., public health, social work, psychiatry), has been assembled to guide the research plan by incorporating input from multidimensional perspective. Trial registration: ClinicalTrials.gov: NCT02543359 Implementation; Therapist training; Learning collaborative; Cascading model; Train-the-trainer; Distance education; Evidence-based treatment; Parent-Child Interaction Therapy - Background Disruptive behavior disorders (DBDs) affect a substantial number of young children, have lifelong implications if left untreated (e.g., [1–7]), and represent the most common presenting problem to community mental health centers [8, 9]. Meta-analytic reviews of treatment outcomes for DBDs (e.g., [10]) demonstrate that there are EBTs for DBDs. Parent–Child Interaction Therapy (PCIT) is a nationally recognized EBT for families who have children with DBDs [11]. The program is unique in comparison to other EBTs for DBDs in that it involves coaching parents as they interact with their young child (ages 2.5 –7 years). For each of two treatment phases, parents attend one didactic parent-only session during which the PCIT therapist teaches parents specific skills that will be “coached” in vivo in subsequent sessions. Parents attend approximately 12–20 weekly, 1-hour clinic-based sessions with their child [12]. Treatment outcome data from multiple randomized trials indicate that PCIT decreases child behavior problems, increases parent skill, and decreases parent stress [12–14]. When compared to waitlist controls, treatment effect sizes for PCIT range from 0.61 to 1.45 (absolute values) for parent report of child behavior and 0.76 to 5.67 for behavior observations of parent skill improvements [14]. Behavior observations indicate pre-post changes in parent behavior such as increased rates of praise, descriptions, reflections, and physical proximity and decreased rates of criticism and sarcasm (e.g., [15]). Parents report lower parenting stress, more internal (rather than external) locus of control, and increased confidence in parenting skills after learning PCIT. Parents report that child behavior improves from the clinical range to within normal limits on multiple, standardized parent report measures [15–17]. Studies have been conducted to understand the maintenance of treatment benefits [18–21], finding th (...truncated)


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Amy Herschell, David Kolko, Ashley Scudder, Sarah Taber-Thomas, Kristen Schaffner, Shelley Hiegel, Satish Iyengar, Mark Chaffin, Stanley Mrozowski. Protocol for a statewide randomized controlled trial to compare three training models for implementing an evidence-based treatment, Implementation Science, 2015, pp. 133, 10, DOI: 10.1186/s13012-015-0324-z