This Project Grant award of $633,671 from the National Institute of Mental Health (NIMH), under the Mental Health Research Grants (CFDA 93.242) program, supports research on the safety of prescription sleep medications in children, adolescents, and young adults with Attention Deficit Hyperactivity Disorder (ADHD). The key objectives are to: 1) Evaluate nationwide patterns of prescription sleep medication use and dose-escalation in youth with ADHD; 2) Determine the extent to which these...
This Project Grant award from the National Institute of Mental Health (NIMH), under the Mental Health Research Grants program (CFDA 93.242), aims to assess the impacts of a 2022 nationwide shortage of immediate-release formulations of amphetamine mixed salts, a class of prescription stimulant medications, on the health outcomes and disparities of youth with Attention-Deficit Hyperactivity Disorder (ADHD). The $729,367 award, granted to The RAND Corporation, will fund a comprehensive research...
This $5.37 million project grant from the National Institutes of Health National Institute on Drug Abuse will fund the development of a context-aware digital adherence intervention called SMARTSTEPS to improve pre-exposure prophylaxis (PrEP) adherence among men who have sex with men with substance use disorder. The grant will support two phases. Phase I will inform the specification of an algorithm that utilizes digital phenotyping data from a smartphone app to anticipate non-adherence based...
This Project Grant from the National Institute on Drug Abuse, part of the Department of Health and Human Services, provides $738,086 to Brown University under the Drug Abuse and Addiction Research Programs (CFDA 93.279) to evaluate a technology-assisted parenting intervention for adolescents in residential substance use treatment. Specifically, the funding supports a randomized controlled trial to test the effectiveness of Parent SMART, a mobile app and telehealth coaching program that...
This Project Grant award from the National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), provides $400,000 to Mountainpass Technology LLC to develop, refine, and evaluate a customized version of their "MyTrials" integrated remote biomarker capture system for decentralized clinical trials (DCTs) focused on substance use disorders (SUDs). The project aims to address key methodological limitations of DCTs for SUDs by creating a product...
The National Institute of Mental Health (NIMH) awarded a Project Grant under the Mental Health Research Grants program (CFDA 93.242) to The Children's Hospital of Philadelphia (CHOP) in the amount of $742,353.00. The grant, titled "Implementation Strategies for Caregiver and Teacher Use of Behavioral Interventions with ADHD: A Pilot Study", aims to develop and pilot test caregiver-facing implementation strategies (Supporting School Success-Caregivers, or SSS-C) to support caregivers of...
The National Institute on Drug Abuse (NIDA) awarded a $306,528 Project Grant under the Drug Use and Addiction Research Programs (CFDA 93.279) to Addinex Technologies, Inc. The grant will fund the development of a medication adherence and monitoring system to support decentralized clinical trials for substance use disorder (SUD). The project aims to adapt Addinex's existing medication management system to provide researchers running SUD clinical trials with a tool for at-home dispensing that...
The National Institute of Mental Health (NIMH) awarded a 5-year, $857,216 Project Grant (CFDA 93.242 - Mental Health Research Grants) to The Children's Hospital Corporation (doing business as Boston Children's Hospital) to study the neurodevelopmental trajectories leading to early symptoms of Attention Deficit Hyperactivity Disorder (ADHD) and disruptive behaviors in socioeconomically disadvantaged, racially and ethnically diverse children. The key objectives of this project are to: 1)...
The National Institute on Drug Abuse (NIDA) awarded a $1,076,018 Project Grant under the Drug Use and Addiction Research Programs (CFDA 93.279) to Dynamicare Health Inc. in Wareham, MA. The award will fund a Phase II randomized clinical trial to evaluate the efficacy of DCH-003, a digital therapeutic that delivers contingency management for the treatment of stimulant use disorder. The trial will compare standard clinic care plus DCH-003 to standard care plus a sham digital app, with the...
This Project Grant award from the National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), will pilot an innovative digital Contingency Management (CM) treatment delivered via mobile device to Medicaid beneficiaries with co-occurring opioid and alcohol use disorders. The $390,000 award, spanning from September 2024 to August 2027, aims to: 1) identify optimal approaches to engage Medicaid beneficiaries in digital CM through Medicaid claims data...
FACILITATING SUPERVISED SELF-MANAGEMENT OF STIMULANT MEDICATIONS AMONG ADOLESCENTS: IMPROVING ADHERENCE, REDUCING STIGMA, AND SUPPORTING CAREGIVERS - PILLSMART: ABSTRACT STIMULANT MEDICATIONS ARE EFFICACIOUS IN REDUCING IMPULSIVITY AND OTHER ADHD SYMPTOMS IN YOUTH, WHICH IS IMPORTANT BECAUSE YOUTH WITH ADHD HAVE AN INCREASED RISK OF DEVELOPING SUBSTANCE USE DISORDERS. YOUTH'S NON-ADHERENCE OF STIMULANT MEDICATIONS IS PREVALENT (~47-60%), AND THE MISUSE OF PRESCRIBED STIMU- LANTS IS INCREASING AMONG YOUTH (~5-34%), WHICH POSES A SERIOUS PUBLIC HEALTH CONCERN. WITHOUT ADEQUATE MONITORING SUPPORT BY PARENTAL CAREGIVERS, STIMULANT MISUSE AND NON-ADHERENCE IN YOUTH CAN INCREASE THE RISK OF SUBSTANCE USE DISORDERS, OVERDOSE, PSYCHOSIS, AND SUICIDALITY. THERE ARE NO AVAILABLE EVIDENCE-BASED TOOLS OR INTERVENTIONS DEMONSTRATED TO IMPROVE STIMULANT ADHERENCE AND REDUCE MISUSE AMONG YOUTH WITH ADHD. MOST ADHERENCE AIDS (E.G., MEDICATION REMINDER APPS, 7-DAY PILL ORGANIZERS, SMART PILL CAPS) FAIL TO AD- DRESS THE POTENTIAL MISUSE OF STIMULANTS AS THEY CANNOT REGULATE MEDICATION ACCESS. PILL DISPENSERS ARE EFFEC- TIVE AT IMPROVING MEDICATION SAFETY AND ADHERENCE, BUT THEY ARE DESIGNED FOR OLDER ADULT/ELDERLY PATIENTS, AND THEY ARE NOT IDEAL FOR YOUTH DUE TO THEIR LARGE AND HEAVY SIZE. OUR PILOT DATA SUGGEST THAT YOUTH ARE CONCERNED ABOUT STIGMA FROM OTHERS WHEN USING THEIR MEDICATION, AND THE USE OF CURRENT DISPENSERS COULD HINDER ADHER- ENCE BY POTENTIALLY SOLICITING UNWANTED ATTENTION AND TRIGGERING ANTICIPATED STIGMA (I.E., WORRY/CONCERN ABOUT NEGATIVE REACTIONS FROM OTHERS). PILLSMART IS A PRIMARY PREVENTION INTERVENTION THAT USES A NOVEL, SLEEK, AND DISCREET PILL DISPENSING DEVICE (PROTOTYPE DEVELOPED) AND MOBILE APP (PROTOTYPE). PILLSMART'S POCKET-SIZED PILL DISPENSER AIMS TO PRE- VENT MISUSE BY SECURELY STORING MEDICATION AND ONLY DISPENSING THE PROGRAMMED DOSE AT THE SCHEDULED TIME. PILLSMART'S INTEROPERATING MOBILE APP AIMS TO IMPROVE ADHERENCE AND MITIGATE THE PARENTAL BURDEN BY FACILITAT- ING REMOTE SUPERVISION OF THE STIMULANT MEDICATION REGIMEN. THE OVERARCHING GOAL OF THIS PROJECT IS TO DEVELOP PILLSMART'S SYSTEM AS AN EVIDENCE-BASED PREVENTION INTERVENTION TO IMPROVE ADOLESCENTS' HEALTH OUTCOMES AS THEY MATURE INTO ADULTHOOD, REDUCE CAREGIVER BURDEN, AND INCREASE MEDICATION ADHERENCE AND SAFETY. THE AIMS OF OUR SBIR PHASE I PROJECT ARE TO FULLY DEVELOP A PORTABLE, AFFORDABLE MEDICATION MANAGE- MENT SYSTEM, TEST ITS USABILITY, AND ASSESS ITS FEASIBILITY TO FACILITATE SELF-MANAGEMENT OF STIMULANT MEDICATIONS AMONG ADOLESCENTS WITH ADHD, IMPROVE MEDICATION ADHERENCE, AND REDUCE PARENTAL CAREGIVER BURDEN. UPON THE COMPLETION OF THE MILESTONES IN PHASE 1, WE WILL BE PREPARED TO TRANSITION INTO PHASE II OF THE RESEARCH WHERE WE PLAN TO CONDUCT A MULTISITE RANDOMIZED CLINICAL TRIAL AND TO INTEGRATE EVIDENCE-BASED BEHAVIORAL AP- PROACHES. WE ANTICIPATE THE TECHNOLOGY'S BENEFITS TO APPLY FOR ADOLESCENTS WITH ADHD AND ALSO ADOLESCENTS WITH OTHER CHRONIC HEALTH CONDITIONS (E.G., DEPRESSION, ANXIETY, TYPE-2 DIABETES).