Adolescent Substance Use Prevention Intervention Research Study in Pediatric Primary Care (ASPIRE)

Computer-facilitated Screening and Brief Intervention (cSBI) in Pediatric Primary Care to Reduce Underage Drinking: a Large, Multi-site Randomized Trial

Our goal is to conduct a large multi-site randomized controlled trial (RCT) of a promising computer-facilitated Screening and clinician Brief Intervention (cSBI) system designed for delivery by pediatric primary care clinicians and aimed at reducing unhealthy alcohol use and related riding/driving safety risk among adolescent patients. Our setting will be the American Academy of Pediatrics' (AAP) Pediatric Research in Office Settings (PROS) national primary care research network, with >600 U.S. primary care practices having participated in recent studies. This trial addresses the evidence gap identified in the latest U.S. Preventive Services Task Force review of alcohol screening and brief counseling interventions among adolescents, and, if shown effective, the cSBI system could be widely disseminated via AAP's existing education, teaching, and advocacy platforms to its 67,000 pediatrician members, thereby greatly increasing the potential for population-level impact of alcohol screening and brief intervention for U.S. adolescents.

Study Overview

• Status: Recruiting
• Conditions: Heavy Drinking; Driving Under the Influence; Riding With Driver Under the Influence
• Intervention / Treatment: Behavioral: Computer-facilitated Screening and Brief Intervention

Detailed Description

Alcohol use disorders frequently have a pediatric origin. Pediatric primary care offices, where the majority of adolescents receive health care, are a promising venue for early identification and intervention through universal screening and brief counseling. However, while the U.S. Preventive Services Task Force recommends primary care-based alcohol screening and brief intervention for adults, it found insufficient evidence to recommend it for adolescents.

The goal of the proposed study is to address this evidence gap by testing the effectiveness of a promising computer-facilitated Screening and Brief Intervention (cSBI) system for delivery by pediatric primary care clinicians to adolescents at well-visits. This cluster-randomized controlled trial will be conducted in the American Academy of Pediatrics' (AAP) Pediatric Research in Office Settings (PROS) national primary care practice-based research network. PROS has demonstrated success in >30 years of practice-based research, with >600 practices participating in recent studies. Drawing on more than 15 years of our prior research on adolescent alcohol screening and brief counseling in primary care offices, the cSBI system was developed to provide a time-efficient and feasible way for pediatric practices to improve both the frequency and quality of alcohol screening and counseling. cSBI includes: 1) computer self-administered screening that adolescents complete prior to seeing their clinician, 2) 10 interactive psychoeducational pages for the adolescent on substance use health risks, 3) a Clinician Report Form with screen results and prompts that clinicians use to provide motivational interviewing-based individualized counseling, and 4) clinician training materials and protocol.

In a New England-based pilot study, we found that, compared to usual care (UC), the cSBI approach: 1) increased patient receipt of alcohol-related counseling during well-visits; 2) improved patients' ratings of the quality of their clinician encounter; and 3) among those who reported past-year use at baseline (n=192), was associated with a 34% lower risk of a heavy episodic drinking episode during 12 months follow-up. cSBI also reduced risk of riding with an impaired driver, a major safety risk associated with alcohol, by 42% among those with prior riding risk.

A larger RCT of this approach, which employs an adequately-powered sample and tests generalizability of effects beyond New England, is needed. We will randomize >30 pediatric primary care clinicians in ~10 practices nationwide to deliver UC or cSBI (1:1) to their eligible and assenting 14- to 17-year-old patients arriving for well-visits. Our aims are to test cSBI's effect on adolescent patients' heavy episodic drinking, and on riding with an impaired driver/driving while impaired, during 12 months follow-up. We hypothesize that, compared to adolescent patients receiving usual care, those receiving cSBI will have lower rates of reporting heavy episodic drinking and riding with an impaired driver/driving while impaired during the study follow-up period.

• Study Type: Interventional
• Enrollment (Estimated): 406
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lydia A Shrier, MD, MPH; Phone Number: 617-355-5133; Email: lydia.shrier@childrens.harvard.edu
• Study Contact Backup: Name: Sion K Harris, PhD; Phone Number: 857-218-4304; Email: sion.harris@childrens.harvard.edu

Study Locations

• United States
  • Illinois
    • Itasca, Illinois, United States, 60143
      • Recruiting
      • American Academy of Pediatrics
      • Contact: Alessandra Torres, MPH; Email: atorres@aap.org
      • Contact: Donna L Harris, MA; Email: dlharris@aap.org
      • Principal Investigator: Alessandra Torres, MPH
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Principal Investigator: Sion K Harris, PhD
      • Principal Investigator: Lydia A. Shrier, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Children's Hospital of Philadelphia
      • Contact: Alexander Fiks, MD, MSCE; Email: fiksa@email.chop.edu
      • Principal Investigator: Alex Fiks, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Ages 14-17
• Presenting for well-visit with participating clinician
• Reports any lifetime alcohol use
• If no lifetime alcohol use, reports riding with a driver under the influence in the past 12 months
• Has own cell phone and is willing to share cell phone number before their scheduled visit
• Completes required pre-visit activity/activities before well visit

Exclusion Criteria:

• Youth in foster care
• Unable to read and communicate in English
• Unable to complete follow-ups
• Currently receiving treatment from specialty clinician(s) for a substance use concern
• Deemed by their clinician to be inappropriate for study participation due to neurodevelopmental delays or medical/emotional concerns

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Clinicians randomized to this arm will not receive training in delivery of cSBI until study completion, and their participating patients will receive usual care.
Experimental: Computer-facilitated screening and brief intervention; Clinicians randomized to this arm will receive training in delivery of cSBI and their participating patients will then receive the experimental intervention.	Behavioral: Computer-facilitated Screening and Brief Intervention; cSBI includes: 1) computer self-administered screening that adolescents complete prior to seeing their clinician, immediately followed by 2) computer-delivered brief psychoeducation on the health risks of substance use to prime patients for the clinician encounter, and 3) a Clinician Report Form with screen results and prompts that clinicians use to provide motivational interviewing-based individualized counseling during the visit.; Other Names: cSBI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any heavy episodic drinking day during past 3 months	Defined using the NIAAA Youth Guide age/gender-specific number of drinks.	3 months follow-up
Any heavy episodic drinking day during past 3 months	Defined using the NIAAA Youth Guide age/gender-specific number of drinks.	6 months follow-up
Any heavy episodic drinking day during past 3 months	Defined using the NIAAA Youth Guide age/gender-specific number of drinks.	9 months follow-up
Any heavy episodic drinking day during past 3 months	Defined using the NIAAA Youth Guide age/gender-specific number of drinks.	12 months follow-up
Time to first day of heavy episodic drinking during 12 month follow-up period	Defined using the NIAAA Youth Guide age/gender- specific number of drinks.	1-12 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any riding/driving risk	Any riding with a driver who had been using alcohol or driving after using alcohol in past 3 months	3 months follow-up
Any riding/driving risk	Any riding with a driver who had been using alcohol or driving after using alcohol in past 3 months	6 months follow-up
Any riding/driving risk	Any riding with a driver who had been using alcohol or driving after using alcohol in past 3 months	9 months follow-up
Any riding/driving risk	Any riding with a driver who had been using alcohol or driving after using alcohol in past 3 months	12 months follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Past 3 months alcohol use days	Number of days of any alcohol use in past 3 months	3 months follow-up
Past 3 months alcohol use days	Number of days of any alcohol use in past 3 months	6 months follow-up
Past 3 months alcohol use days	Number of days of any alcohol use in past 3 months	9 months follow-up
Past 3 months alcohol use days	Number of days of any alcohol use in past 3 months	12 months follow-up
Past 3 months heavy episodic drinking days	Number of days of heavy episodic drinking in past 3 months	3 months follow-up
Past 3 months heavy episodic drinking days	Number of days of heavy episodic drinking in past 3 months	6 months follow-up
Past 3 months heavy episodic drinking days	Number of days of heavy episodic drinking in past 3 months	9 months follow-up
Past 3 months heavy episodic drinking days	Number of days of heavy episodic drinking in past 3 months	12 months follow-up
Perceived risk of harm	Percent report perceiving moderate/great risk of harm from regular heavy episodic drinking	3 months follow-up
Perceived risk of harm	Percent report perceiving moderate/great risk of harm from regular heavy episodic drinking	6 months follow-up
Perceived risk of harm	Percent report perceiving moderate/great risk of harm from regular heavy episodic drinking	12 months follow-up
Drinking refusal self-efficacy	Score on Drinking Refusal Self-Efficacy measure	3 months follow-up
Drinking refusal self-efficacy	Score on Drinking Refusal Self-Efficacy measure	6 months follow-up
Drinking refusal self-efficacy	Score on Drinking Refusal Self-Efficacy measure	12 months follow-up
Alcohol-related problems or negative consequences experienced since post-visit survey	Score on scale	6 months follow-up
Alcohol-related problems or negative consequences experienced since post-visit survey	Score on scale	12 months follow-up

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Children's Hospital of Philadelphia; American Academy of Pediatrics
• Investigators: Principal Investigator: Lydia A Shrier, MD, MPH, Boston Children's Hospital; Principal Investigator: Sion K Harris, PhD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2023
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: June 25, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: NIAAA_1R01AA027253-01A1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will provide a variable codebook along with the dataset. We will make a de-identified version of the complete and cleaned study dataset available to the AAP's PROS Study Archive at study completion, as well as NIAAA Data Archive (NIAAADA).
• IPD Sharing Time Frame: Within 12 months of study completion.
• IPD Sharing Access Criteria: We will share the dataset with external investigators when a data use agreement (DUA) is executed between Boston Children's Hospital and the institution of the person making the request. The DUA will specify the requested data elements (each of which must be justified), the specific research question, the timeline for the project and schedule for data destruction.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No