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Clinical Trial Summary

This study aims to advance the science of mental health services for adolescent externalizing problems (AEPs) by developing therapist training procedures to increase fidelity to evidence-based interventions (EBIs) in usual care. Two widely endorsed approaches are consistently effective for treating AEPs: family therapy and CBT. Importantly, stronger fidelity to core EBIs of these approaches predicts better outcomes in research and community settings. Yet these EBIs are not widely implemented with fidelity. To help close this quality gap in adolescent services, investigators will develop an online intervention to strengthen fidelity to these EBIs in routine care: Measurement Training and Feedback System for implementation (MTFS-I). MTFS-I will target two essential aspects of EBI fidelity: Training components will seek to improve EBI self-monitoring, and a Feedback component will seek to increase EBI utilization. In keeping with NIMH's Experimental Therapeutics paradigm, this study will examine whether an Intervention (MTFS-I) has direct impact on immediate Targets (EBI self-monitoring and utilization). If promising, future R01 studies will examine links among intervention, targets, and ultimate outcomes (AEPs). The MTFS-I package will be an online quality assurance system completed by therapists and supervisors that can be readily sustained in usual care. Two weekly Training components will adapt gold-standard observational fidelity coding procedures to promote improved self-monitoring of the targeted EBIs, and a monthly Feedback component will adapt a measurement feedback system to promote increased utilization of these EBIs in everyday practice. To maximize provider investment, sites will delineate their own fidelity standards for family therapy and CBT and help design feedback report templates. The proposed study will be among the first to (1) test whether training therapists in observational assessment of EBI fidelity increases the accuracy with which they self-monitor use of those EBIs and (2) adapt measurement feedback procedures to track and improve therapist utilization of EBIs. To achieve study aims the investigators will first partner with two community clinics to develop sustainable MTFS-I procedures using a three-phase Pilot process. Investigators will then initiate an experimental Trial during which therapists (n = 32, treating 192 clients) at four different clinics will be randomized to MTFS-I versus no-intervention Control. In both conditions two kinds of data will be collected: therapist-report checklists on use of core family therapy and CBT techniques with adolescent cases and treatment session audio recordings. MTFS-I uptake will be tracked electronically for online components (Aim 1: MTFS feasibility). Session recordings will be coded by observers for three facets of EBI fidelity: adherence (extent of EBI utilization), working alliance, and therapist competence. Observer ratings will measure the strength of EBI self-monitoring (Aim 2: therapist reliability and accuracy) and fidelity (Aim 3 [EBI utilization] & Aim 4 [alliance, competence]). If effective, MTFS-I could be adapted to promote EBI fidelity for a variety of clinical populations and approaches.


Clinical Trial Description

Discovering and disseminating effective methods to improve the quality of available treatment services for adolescent externalizing problems is an urgent public health priority. Despite the strong legislative and policy focus on quality of care evident in the CHIP Reauthorization Act of 2009 and the Affordable Care Act of 2010, comprehensive reports underscore the enduring "quality chasm" between behavioral treatments proven in controlled research versus those commonly practiced in usual care. The quality gap is highly evident for adolescent externalizing problems (AEPs), which encompass serious conduct problems, delinquency, and substance misuse. AEPs are the most common adolescent behavioral issues in specialty care, which follows from high prevalence rates: conduct disorder has a 9.5% lifetime prevalence rate, and 19% of adolescents report past-year illicit drug use with 7% meeting criteria for psychiatric disorder. Yet standard treatment quality for AEPs is considered mediocre to inadequate due to a host of factors headlined by the absence or modest quality of evidence-based services, insufficient provider training, and little quality monitoring. Two behavioral treatment approaches are prime candidates for upgrading the quality of AEP treatment services. Both family therapy (FT) and cognitive-behavioral therapy (CBT) have excellent efficacy evidence for AEPs in both research and community settings. Each has strong support for treating serious conduct problems, delinquency, and substance use, and each has several manualized versions proven efficacious across the AEP range. Due to this extensive evidence base, there is incentive from clinical providers and payers to deliver these approaches in routine care: Both are now approved for treating AEPs by federal and private insurance plans and by regulatory agencies that govern licensed treatment providers. Notably, therapists report that both approaches are highly valued in everyday practice. By consensus, the most efficient pathway toward improving the quality of mental health services is to increase the adoption and delivery of evidence-based interventions (EBIs) in usual care. However, there is a caveat: For EBIs to be effective in frontline settings, they must be delivered with sufficient fidelity to the principles and procedures of the approaches they represent. This remains a most difficult challenge for which innovative solutions are sorely needed. With regard to AEPs, controlled studies have shown that strong fidelity to the FT and CBT approaches predicts improved client outcomes in both efficacy and effectiveness studies. Yet, at this time, neither FT nor CBT are widely implemented with fidelity in community clinics that treat AEPs. To promote EBI fidelity as a core virtue of the behavioral care system, the study team published a theoretical model in which EBI implementation is recognized as an essential driver of positive client outcomes. This model includes structural characteristics of care that directly influence both implementation and outcomes, as well as outcomes considered relevant within the "quality of care" framework. The middle section depicts elements of implementation that have proven salient for effective EBI delivery, including technical factors (adherence to core treatment techniques, therapist competence) and relational factors (e.g., alliance), given that both are related to outcomes. According to this model and similar others, EBI implementation fidelity is a multidimensional construct with three primary facets: Adherence (extent to which signature EBI techniques are utilized), Competence (skillfulness and responsiveness of EBI delivery), and Alliance (working relationship between provider and client). In AEP research, fidelity-outcome studies consistently find that stronger EBI adherence and stronger alliance predict better client outcomes. Evidence for competence-outcome effects is less consistent, in large part because competence remains difficult to operationalize reliably. According to this framework, innovations aimed at improving service quality should directly target EBI fidelity; stronger EBI fidelity will then boost client outcome. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03722654
Study type Interventional
Source The National Center on Addiction and Substance Abuse at Columbia University
Contact
Status Completed
Phase N/A
Start date September 1, 2020
Completion date June 30, 2022

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