SBIR-STTR Award

Advances in treating adolescent substance abuse and related problems have resulted in an increased emphasis on redirecting resources to transport evidence-based treatments (EBTs) into “real-world” settings, yet the science-practice gap remains a pressing problem. Due to highly complex and multifaceted processes involved in translating EBTs to practice settings and to a host of diffusion barriers, including lack of resources, infrastructure, and technology-based and quality assurance capacity, only a fraction of individuals in treatment for substance use disorder (SUD) receive EBTs. Further, the significant gains achieved in efficacy trials are difficult to replicate in actual practice without intensive monitoring of fidelity, an essential component of success. The lack of feasible cost efficient fidelity monitoring tools and superstructures to ensure community- based practitioners sustain competent and adherent service delivery represents a major impediment for dissemination; innovative methods and procedures are urgently needed. The proposed Phase I SBIR will involve the development of a prototype theory-guided, empirically based, and user-friendly online feedback and monitoring system to guide and sustain the implementation of Functional Family Therapy (FFT) for adolescent substance abuse, a well-established treatment shown to reduce substance use and related problems and enhance youth and family adaptive functioning. The tracking system “Adherence and Clinical Effectiveness” (ACE) will be designed to foster clinicians' self-regulation of treatment adherence and provide community programs with more direct access to quality assurance information pertinent to maintaining fidelity and achieving positive youth and family treatment outcomes. The adoption of the system is expected to bridge the science-practice gap, enhancing the appeal, user-friendliness, and marketability of FFT dissemination services delivered to adolescent outpatient drug treatment programs by LIFFT, Co. Phase I will focus on creating content, and developing and testing the functionality and feasibility of a prototype of the web-based ACE system. Phase II will complete the development of a fully functional, full-featured, commercially viable program and evaluate, in a randomized controlled trial, the acceptability and effectiveness of ACE for enhancing sustainability in treatment settings. The specific aims are: Aim 1: Develop content for ACE, based on FFT theory, empirical evidence, and our prior extensive FFT training, supervision, and dissemination experiences. Aim 2: Program an Alpha prototype of the ACE online framework that contains the basic essential elements of text, graphics, and interactive features. The prototype will include a secure website and fillable electronic forms and other mechanisms for data collection, storage, and retrieval for dashboard data summary and clinical reports. Aim 3: Test the functionality and feasibility of the ACE prototype with an independent pilot sample of 15 FFT clinicians and supervisors. Functionality testing will include login procedures, navigation, uploading of audio files (i.e., “proxy” therapy recordings), and online form submission.

Public Health Relevance Statement:
This project will develop and test a web-based feedback and monitoring system to support the dissemination of Functional Family Therapy (FFT), an evidence-based treatment shown to significantly reduce adolescent substance use and related health problems. The system will be designed to foster clinicians' self-regulation of treatment adherence and provide community programs with more direct access to quality assurance information pertinent to maintaining fidelity and achieving positive youth and family treatment outcomes. The integration of the system is expected to bridge the science-practice gap, enhancing the appeal, user- friendliness, and marketability of FFT dissemination services delivered to adolescent outpatient drug treatment programs by LIFFT, Co.

NIH Spending Category:
Behavioral and Social Science; Bioengineering; Brain Disorders; Clinical Research; Clinical Trials and Supportive Activities; Comparative Effectiveness Research; Drug Abuse (NIDA only); Mental Health; Pediatric; Pediatric Research Initiative; Prevention; Substance Abuse; Substance Abuse Prevention

Project Terms:
addiction; Address; Adherence (attribute); Administrator; Adolescent; adolescent substance abuse; adolescent substance use; Adoption; Attitude; base; Behavior; Clinical; Clinical Data; Clinical effectiveness; Clinical Services; Collection; Communities; Complex; cost efficient; Data; Data Collection; design; Development; Diffusion; Effectiveness; efficacy trial; Electronics; Elements; Ensure; Evidence based treatment; experience; Family; Family psychotherapy; Feedback; Fostering; Frequencies (time pattern); Generic Drugs; Goals; Health; Healthcare; Individual; Informal Social Control; innovation; Internet; Link; Measures; Methods; Modeling; Monitor; Online Systems; Outcome; Outpatients; Participant; Patient Self-Report; Performance; Pharmaceutical Preparations; Phase; Procedures; Process; programs; prototype; Proxy; quality assurance; Randomized Controlled Trials; reduced substance use; Reporting; Research Infrastructure; Resources; Retrieval; Sampling; Science; Secure; Services; Site; Small Business Innovation Research Grant; Substance Use Disorder; success; Supervision; System; Systems Integration; Technology; Testing; Text; theories; tool; Training; Translating; treatment adherence; Treatment outcome; treatment program; usability; user-friendly; web site; Youth

Advances in treating adolescent substance abuse and related problems have resulted in an increased emphasis on redirecting resources to transport evidence-based treatments (EBTs) into “real-world” settings, yet the science-practice gap remains a pressing problem. Due to highly complex and multifaceted processes involved in translating EBTs to practice settings and to a host of diffusion barriers, including lack of resources, infrastructure, and technology-based and quality assurance capacity, only a fraction of individuals in treatment for substance use disorder (SUD) receive EBTs. Further, the significant gains achieved in efficacy trials are difficult to replicate in actual practice without intensive monitoring of fidelity, an essential component of success. The lack of feasible cost efficient fidelity monitoring tools and superstructures to ensure community-based practitioners sustain competent and adherent service delivery represents a major impediment for dissemination; innovative methods and procedures are urgently needed. The proposed Phase II SBIR will complete the development of a commercially viable theory-guided, empirically based, and user-friendly online feedback and monitoring system, “Fidelity, Assessment, and Clinical Effectiveness Tracking” (FACET), to guide and sustain the implementation of EBTs and evaluate the system in a randomized trial. FACET is designed to foster clinicians' self-regulation of treatment adherence and provide community programs with more direct access to quality assurance information pertinent to maintaining fidelity and achieving positive youth and family treatment outcomes. The randomized trial will be conducted in staggered cohorts, with a sequential roll-out of training for clinicians within cohorts (n=60; 20 per cohort) to enhance study feasibility. Clinicians will be trained to deliver Functional Family Therapy (FFT), an established treatment for adolescent substance abuse and co-occurring problems. Within each cohort, treatment sites will be randomized to either Implementation as Usual (IAU) or FACET-assisted implementation (FAI) and clinicians will participate in the condition of their employing site. Measurement will involve multi-method, multi-source data collection. Clinicians will complete five assessments over a 9-month period. The impact of FAI, compared to IAU on implementation outcomes will be assessed using measures of clinician EBT knowledge and efficacy, behavioral observations of clinician EBT skills, and work process improvements linked to staff time savings for potential customers. The adoption of FACET is expected to bridge the science-practice gap and enhance the appeal, user-friendliness, and marketability of FFT dissemination services delivered to adolescent outpatient drug treatment programs by LIFFT, Co. The proposed project will result in an evidence-based monitoring system that can be marketed within a repeatable and scalable business model. The primary long-term goal of this project is to establish a data-driven foundation for marketing the commercial FACET system in conjunction with EBT dissemination and establish the potential for FACET for other domains.

Public Health Relevance Statement:
This Phase II SBIR project will complete the development of and formally evaluate a commercially viable web-based feedback and monitoring system to support the implementation and sustainability of evidence-based treatments. The system is designed to foster clinicians' self-regulation of treatment adherence and provide community programs with direct access to quality assurance information to guide the sustainment of effective treatments for youth with substance abuse and related problem behaviors. The completed system will facilitate expanding access to quality services and will enhance the appeal, user-friendliness, and marketability of dissemination services for evidence-based treatments.

Project Terms:
Achievement; Adherence; Administrator; Adolescent; adolescent substance abuse; adolescent substance use; Adoption; Asthma; base; Behavior; behavior change; behavior observation; behavioral health; Businesses; Chronic; Client; Clinical; Clinical effectiveness; clinical practice; cohort; commercialization; Communities; Community of Practice; Community Practice; Complex; cost effective; cost efficient; Cost Savings; dashboard; Data; Data Collection; Data Sources; design; Development; Diabetes Mellitus; Diffusion; Disease; Documentation; effective therapy; Effectiveness; efficacy trial; Ensure; Ethnic group; evidence base; Evidence based program; Evidence based treatment; Exhibits; Family; Family psychotherapy; Feasibility Studies; Feedback; follow-up; Fostering; Foundations; Goals; Happiness; Health Personnel; Health system; HIV risk; improved; indexing; Individual; Informal Social Control; information assurance; innovation; Innovation Corps; Interview; Knowledge; Lifestyle-related condition; Link; Manuals; Marketing; Measurement; Measures; Mediating; Medical; Mental Depression; Methods; Modeling; Monitor; Online Systems; Outcome; Outpatients; Perception; Performance; Pharmacotherapy; Phase; Preparation; Procedures; Process; Productivity; programs; prototype; quality assurance; Randomized; randomized trial; reduced substance use; Registries; Reporting; Research; Research Infrastructure; Resources; satisfaction; Savings; Science; Self Efficacy; Services; Site; skill acquisition; skills; Small Business Innovation Research Grant; Substance abuse problem; Substance Use Disorder; success; System; Technology; theories; Thinness; Time; tool; Training; Translating; Translations; Trauma; treatment adherence; treatment center; Treatment outcome; treatment program; treatment site; user-friendly; web site; Work; Youth