Our PROS Studies

ASPIRE

Adolescent Substance use Prevention Intervention REsearch Study

The purpose of this study is to conduct a randomized controlled trial, with usual care control, to examine the effectiveness of a computer-facilitated Screening and Brief Intervention (cSBI) system, also known as the online CRAFFT Interactive tool.

Study Details

• Question(s) Being Addressed: Can we change the trajectory of teens at risk for substance use?
• Goal: To test the effectiveness of a computer-facilitated alcohol screening and brief intervention system among adolescents to reduce: 
  • Heavy episodic drinking among at-risk adolescents
  • Driving while impaired
  • Riding with an impaired driver
• Methods: Randomized Controlled Trial (RCT)
• Timeline: April 2020 - March 2026
• Status: Practice Recruitment Completed; Participant Recruitment Completed; Data Collection Underway
• Study PI(s): Lydia Shrier, MD, MPH & Sion Harris, PhD
• Partnership(s): Boston Children’s Hospital
• Funder: NIH National Institute on Alcohol Abuse and Alcoholism (NIAAA)

BIOS

Broad Implementation of Outpatient Stewardship

The purpose of this study is to conduct a randomized controlled trial, with a waitlist control, to implement the BIOS Antibiotic Stewardship Quality Improvement (QI) Program among clinicians treating children for Acute Respiratory Tract Infections (ARTIs) in outpatient practice settings.

Study Details

• Question(s) Being Addressed: Can health systems improve antibiotic stewardship?
• Goal 1: To examine the acceptability, feasibility, and utility of an implementation strategy on improving adoption and impact of the PARTI (Prescribing Antibiotics for Respiratory Tract Infections) intervention in primary care, family medicine, med-peds, and urgent care sites.
• Goal 2: To measure the effectiveness of the PARTI intervention to reduce broad-spectrum antibiotic use for children 6 months to 12 years old with ARTIs in varied outpatient settings.
• Methods: Randomized Controlled Trial (RCT); Key Informant Interviews (KIIs)
• Timeline: February 2020 - February 2026
• Status: Data Collection Completed; Data Analysis / Manuscript Development Underway
• Study PI(s): Jeff Gerber, MD, PhD & Alex Fiks, MD, MSCE
• Partnership(s): Children’s Hospital of Philadelphia
• Funder: Patient-Centered Outcomes Research Institute (PCORI)

DREAMS

Developing Routines for Early Adolescent Media and Sleep

The purpose of this study is to use the existing American Academy of Pediatrics (AAP) Family Media Plan (FMP) technology structure and functionality to create a sleep-focused FMP (sFMP) and then seek input from clinicians, parents and adolescents to refine and adapt the existing FMP for a more sleep-focused approach.

Study Details

Question(s) Being Addressed: Can a more focused version of the existing AAP Family Media Plan (FMP) help pediatricians provide better counseling on technology and digital media that expands past our age-appropriate sleep duration guidance and creates more positive outcomes for families?

Goal: To adapt the current AAP FMP into a sleep-enhanced “sFMP” and set the stage for a larger pilot trial.

Methods: Interviews / Focus Groups

Timeline: January 2025 - December 2025

Status: Actively Recruiting Participants

Study PI(s): Ariel Williamson, PhD & Megan Moreno, MD, MSEd, MPH

Partnership(s): University of Oregon & University of Wisconsin - Madison

Funder: AAP Friends of Children Fund

HEART+

HElp At-Risk Teens Thrive

The purpose of this study is to help clinicians identify and provide support to adolescents at risk for suicidal behavior by utilizing the integrated Care to Help At-Risk Teens (iCHART) intervention, enhanced with computerized As Safe As Possible modules (iCHART-cASAP). With these tools, clinicians may offer adolescents at risk of suicide being seen in a setting without onsite Behavioral Health (BH) services some support. Such support will be initiated and sustained until adolescents can receive comprehensive BH services.

Study Details

Question(s) Being Addressed: Can primary care pediatricians help prevent suicide in teens?

Goal: To adapt and collect preliminary effectiveness data on a digital suicide prevention intervention that can be delivered in pediatric primary care settings by front line pediatricians.

Methods: Interviews / Focus Groups; Randomized Controlled Trial (RCT)

Timeline: June 2023 - April 2026

Status: Practice Recruitment Completed

Study PI(s): Stephanie Stepp, PhD

Partnership(s): University of Pittsburgh

Funder: NIH National Institute of Mental Health (NIMH)

SAFE Study

Secure All Firearms Every time

The purpose of this study is to listen to and deeply understand Navajo Nation community members’ thoughts related to firearms, secure storage, and the SAFE Firearm program.

Study Details

• Question(s) Being Addressed: Can a modified SAFE Firearm program – adapted based on multiple cycles of feedback from Navajo Nation community members and the Advisory Board – changes how families store firearms?
• Goal: To adapt the SAFE Firearm program to be culturally relevant, appropriate, and usable in varied settings based on Navajo Nation community members’ feedback so as to reduce firearm-related trauma.
• Methods: Randomized Controlled Trial (RCT); Focus Groups / Interviews
• Timeline: January 2026 – December 2027
• Status: In Development
• Study PI(s): Novalene Goklish, MS, DBH, Jennifer Richards, PhD, MPH, & Everly Macario, ScD, MS, EdM
• Partnership(s): Johns Hopkins Center for Indigenous Health
• Funder: Kaiser Permanente Center for Gun Violence Research and Education

Text4Vax

The purpose of this study is to conduct a randomized controlled trial, specifically a Hybrid Type 2 implementation effectiveness trial with a seasonal control, to examine the impact of vaccine text message reminders on timeliness of receipt, the elements that may affect future reminder language, and the effectiveness of our reminder implementation strategy.

Study Details

• Question(s) Being Addressed: Do text message reminders containing health related information encourage parents to vaccinate their children against the flu,
  and how can these text messages be optimized for easy and standardized use amongst practices?
• Goal: To assess the use of influenza vaccine text messages to provide healthrelated information that parents find informative as well as the parent / child characteristics that affect engagement with these informational influenza vaccine text messages, and to identify contextual factors, facilitators, and barriers to implementation and sustainability of said health-related text messages. 
• Methods: Randomized Controlled Trial (RCT); Key Informant Interviews (KIIs)
• Timeline: April 2024 - March 2027
• Status: Practice Recruitment Completed; Data Collection Underway
• Study PI(s): Melissa S. Stockwell, MD, MPH & Alex Fiks, MD, MSCE
• Partnership(s): Columbia University, Children’s Hospital of Philadelphia / University of Pennsylvania School of Medicine, & Physicians Computer Company
• Funder: NIH National Institute of Allergy and Infectious Diseases (NIAID)

TIPP-C Study

Telemedicine Care Integrated into Pediatric Primary Care and Child Outcomes

The purpose of this study is to identify ways to optimize and integrate telemedicine into pediatric primary care to improve child health and health equity.

Study Details

• Question(s) Being Addressed: Can practice-level factors that either optimize or undermine telemedicine use be identified and adjusted for?
• Goal: To fill the gap between the increased use of telemedicine and the lack of best practice guidelines to provide and sustain high-quality and equitable telemedicine.  
• Methods: Secondary Data Analyses; Key Informant Interviews (KIIs)
• Timeline: June 2023 – October 2027
• Status: Practice Recruitment Completed; Data Collection Underway
• Study PI(s): Alex Fiks, MD, MSCE & Kristin Ray, MD, MS
• Partnership(s): Children’s Hospital of Philadelphia, University of Pittsburgh
• Funder: NIH National Institute of Child and Human Development (NICHD)

CER² & Our Secondary Data Analysis Projects

Comparative Effectiveness Research through Collaborative Electronic Reporting

CER² is an enduring research collaboration through which different groups contribute to a pooled electronic health record (EHR) database encompassing over 3 million children across the US. More specifically, CER² is a consortium of institutions partnering with and often represented by primary care informatics researchers who study pediatric care through clinical data extracted from EHRs and related electronic data.

Program Details

Topic(s) Being Addressed: Each research topic is uniquely driven by its individual investigators. Some examples include the following:

• Food allergy documentation patterns in children in the era of early food introduction (i.e., early peanut introduction)
• Pediatric hypertension
• Quality of pediatric body measurement data (e.g., head circumference, height, weight)

Goal: To give pediatric researchers access to a large database of EHR clinical and billing data so they may conduct retrospective cohort and observational low-cost comparative effectiveness research studies, potentially collect prospective data from a subset of families, and potentially conduct randomized controlled trials on pediatric drug therapeutics and other child health topics.

Methods: Secondary Data Analyses

Timeline: Ongoing Since 2012

Status: Active

Study PI(s): Alex Fiks, MD, MSCE

Partnerships: The following organizations are part of and provide data to the CER² Consortium...

• The American Academy of Pediatrics (AAP)
• The Children’s Hospital of Philadelphia (CHOP) 
• Boston University
• MetroHealth  

Funder: AAP & HRSA Maternal & Child Health Bureau (MCHB)