Brigid R. Marriott , Leslie Hulvershorn , Johnathan Oliver , Cara Jones , Lauren M. O'Reilly , Sarah E. Wiehe , Patrick O. Monahan , Sarah Kate Bearman , Lisa Saldana , Matthew C. Aalsma
{"title":"通过综合护理和任务转移改善青少年获得行为健康服务的机会:一项集群随机阶梯楔形临床试验方案","authors":"Brigid R. Marriott , Leslie Hulvershorn , Johnathan Oliver , Cara Jones , Lauren M. O'Reilly , Sarah E. Wiehe , Patrick O. Monahan , Sarah Kate Bearman , Lisa Saldana , Matthew C. Aalsma","doi":"10.1016/j.conctc.2025.101518","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>One promising solution for improving access to mental health services is integrated behavioral health models, in which behavioral health providers address mental health problems within the primary care infrastructure. Additionally, task-shifting, where non-specialists deliver certain services in the place of specialists, may be well-suited to address mental health provider shortages. The current study outlines the protocol for a hybrid type III implementation-effectiveness, cluster-randomized stepped wedge trial to evaluate the implementation of an adapted pediatric integrated behavioral health model (Peds IBH) that includes task-shifting services, explore the facilitators and barriers to the implementation of Peds IBH, and examine connection to behavioral health care pre- and post-implementation.</div></div><div><h3>Methods</h3><div>The trial will include 25 pediatric primary care clinics across 13 counties in a large healthcare system. Clinics will be randomized to one of three cohorts, stepped in at 6-month intervals, with a 12-month implementation period. The Peds IBH program will: 1) incorporate task-shifting to treat mild to moderate anxiety, depression, and conduct problems with flexible, transdiagnostic cognitive-behavior therapy to be delivered by bachelor's level interventionists, 2) leverage existing child psychiatry provider consultation programs, and 3) increase sustainability through a different billing model. Quantitative data collection will include surveys (primary care team members, behavioral health providers, and youth and caregivers) and tracking of implementation strategies. Qualitative interviews will be conducted with primary care providers and staff.</div></div><div><h3>Discussion</h3><div>This trial will evaluate the implementation of the Peds IBH program. While the focus is implementation outcomes, we will assess effectiveness to inform future dissemination efforts.</div></div><div><h3>Trial registration</h3><div>N/A.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101518"},"PeriodicalIF":1.4000,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Improving youth access to behavioral health services through integrated care and task shifting: protocol for a cluster-randomized stepped wedge clinical trial\",\"authors\":\"Brigid R. Marriott , Leslie Hulvershorn , Johnathan Oliver , Cara Jones , Lauren M. O'Reilly , Sarah E. Wiehe , Patrick O. Monahan , Sarah Kate Bearman , Lisa Saldana , Matthew C. Aalsma\",\"doi\":\"10.1016/j.conctc.2025.101518\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>One promising solution for improving access to mental health services is integrated behavioral health models, in which behavioral health providers address mental health problems within the primary care infrastructure. Additionally, task-shifting, where non-specialists deliver certain services in the place of specialists, may be well-suited to address mental health provider shortages. The current study outlines the protocol for a hybrid type III implementation-effectiveness, cluster-randomized stepped wedge trial to evaluate the implementation of an adapted pediatric integrated behavioral health model (Peds IBH) that includes task-shifting services, explore the facilitators and barriers to the implementation of Peds IBH, and examine connection to behavioral health care pre- and post-implementation.</div></div><div><h3>Methods</h3><div>The trial will include 25 pediatric primary care clinics across 13 counties in a large healthcare system. Clinics will be randomized to one of three cohorts, stepped in at 6-month intervals, with a 12-month implementation period. The Peds IBH program will: 1) incorporate task-shifting to treat mild to moderate anxiety, depression, and conduct problems with flexible, transdiagnostic cognitive-behavior therapy to be delivered by bachelor's level interventionists, 2) leverage existing child psychiatry provider consultation programs, and 3) increase sustainability through a different billing model. Quantitative data collection will include surveys (primary care team members, behavioral health providers, and youth and caregivers) and tracking of implementation strategies. Qualitative interviews will be conducted with primary care providers and staff.</div></div><div><h3>Discussion</h3><div>This trial will evaluate the implementation of the Peds IBH program. 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Improving youth access to behavioral health services through integrated care and task shifting: protocol for a cluster-randomized stepped wedge clinical trial
Background
One promising solution for improving access to mental health services is integrated behavioral health models, in which behavioral health providers address mental health problems within the primary care infrastructure. Additionally, task-shifting, where non-specialists deliver certain services in the place of specialists, may be well-suited to address mental health provider shortages. The current study outlines the protocol for a hybrid type III implementation-effectiveness, cluster-randomized stepped wedge trial to evaluate the implementation of an adapted pediatric integrated behavioral health model (Peds IBH) that includes task-shifting services, explore the facilitators and barriers to the implementation of Peds IBH, and examine connection to behavioral health care pre- and post-implementation.
Methods
The trial will include 25 pediatric primary care clinics across 13 counties in a large healthcare system. Clinics will be randomized to one of three cohorts, stepped in at 6-month intervals, with a 12-month implementation period. The Peds IBH program will: 1) incorporate task-shifting to treat mild to moderate anxiety, depression, and conduct problems with flexible, transdiagnostic cognitive-behavior therapy to be delivered by bachelor's level interventionists, 2) leverage existing child psychiatry provider consultation programs, and 3) increase sustainability through a different billing model. Quantitative data collection will include surveys (primary care team members, behavioral health providers, and youth and caregivers) and tracking of implementation strategies. Qualitative interviews will be conducted with primary care providers and staff.
Discussion
This trial will evaluate the implementation of the Peds IBH program. While the focus is implementation outcomes, we will assess effectiveness to inform future dissemination efforts.
期刊介绍:
Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.