Heavy DrinkingASPIRENCT04450966
Adolescent Substance Use Prevention Intervention Research Study in Pediatric Primary Care
A study testing Computer-facilitated Screening and Brief Intervention in people with Heavy Drinking and Driving Under the Influence, run by Boston Children's Hospital at 3 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Heavy Drinking, Driving Under the Influence, Riding With Driver Under the Influence
- What is being tested?
- Computer-facilitated Screening and Brief Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Mar 2023to 13 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Boston Children's Hospital
Boston, Massachusetts, 02115
American Academy of Pediatrics
Itasca, Illinois, 60143
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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.
- Being tested
- Computer-facilitated Screening and Brief Intervention
- Medical subject headings
- Driving Under the Influence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-facilitated Screening and Brief InterventionBehavioural
Also called cSBI
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Clinicians randomized to this arm will not receive training in delivery of cSBI until study completion, and their participating patients will receive usual care. |
| Computer-facilitated screening and brief intervention | Experimental | Clinicians randomized to this arm will receive training in delivery of cSBI and their participating patients will then receive the experimental intervention. Receives: Behavioral: Computer-facilitated Screening and Brief Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any heavy episodic drinking day during past 3 months
Defined using the NIAAA Youth Guide age/gender-specific number of drinks.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1-12 months follow-up
Secondary outcomes (4)
Any riding/driving risk
Any riding with a driver who had been using alcohol or driving after using alcohol in past 3 months
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start10 Mar 2023
- Primary completion25 Mar 2026
- Study completion13 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heavy DrinkingStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-site cluster-randomized parallel groups trial. \>30 pediatric primary care clinicians will be recruited from \~10 practices and will be allocated 1:1 to either deliver usual care or the cSBI intervention to their participating patients ages 14-17 years-old.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Pediatrics, Children's Hospital of Philadelphia, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Sion Kim Harris, Harvard Medical School (HMS and HSDM)
- Investigators
- Sion K Harris, PhD, Principal investigator, Boston Children's HospitalLydia A Shrier, MD, MPH, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450966
- Sponsor's protocol ID
- NIAAA_1R01AA027253-01A1
- Acronym
- ASPIRE
- Status last verified
- May 2026
- First submitted
- 25 Jun 2020
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
Shrier LA, O'Connell MM, Torres A, Shone LP, Fiks AG, Plumb JA, Maturo JL, McCaskill NH, Harris D, Burke PJ, Felt T, Murphy ML, Sherritt L, Harris SK. Computer-Facilitated Screening and Brief Intervention for Alcohol Use Risk in Adolescent Patients of Pediatric Primary Care Offices: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2024 Mar 26;13:e55039. doi: 10.2196/55039.
PubMed 38530346
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-facilitated Screening and Brief Intervention (cSBI) in Pediatric Primary Care to Reduce Underage Drinking: a Large, Multi-site Randomized Trial
- ClinicalTrials.gov ID
- NCT04450966
- Acronym / sponsor ID
- ASPIRE / NIAAA_1R01AA027253-01A1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- American Academy of Pediatrics, Children's Hospital of Philadelphia, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 25 Mar 2026 (actual)
- Study completion
- 13 May 2026 (actual)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multi-site cluster-randomized parallel groups trial. >30 pediatric primary care clinicians will be recruited from ~10 practices and will be allocated 1:1 to either deliver usual care or the cSBI intervention to their participating patients ages 14-17 years-old.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Clinicians randomized to this arm will not receive training in delivery of cSBI until study completion, and their participating patients will receive usual care. |
| Computer-facilitated screening and brief intervention | Experimental | Behavioral: Computer-facilitated Screening and Brief InterventionClinicians randomized to this arm will receive training in delivery of cSBI and their participating patients will then receive the experimental intervention. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-facilitated Screening and Brief InterventionAlso: cSBIcSBI 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. | Behavioural | Computer-facilitated screening and brief intervention |
Primary outcome
Any heavy episodic drinking day during past 3 months
Time frame: 3 months follow-up
Defined using the NIAAA Youth Guide age/gender-specific number of drinks.
Any heavy episodic drinking day during past 3 months
Time frame: 6 months follow-up
Defined using the NIAAA Youth Guide age/gender-specific number of drinks.
Any heavy episodic drinking day during past 3 months
Time frame: 9 months follow-up
Defined using the NIAAA Youth Guide age/gender-specific number of drinks.
Any heavy episodic drinking day during past 3 months
Time frame: 12 months follow-up
Defined using the NIAAA Youth Guide age/gender-specific number of drinks.
Time to first day of heavy episodic drinking during 12 month follow-up period
Time frame: 1-12 months follow-up
Defined using the NIAAA Youth Guide age/gender- specific number of drinks.
4 secondary outcomes
Any riding/driving risk
Time frame: 3 months follow-up
Any riding/driving risk
Time frame: 6 months follow-up
Any riding/driving risk
Time frame: 9 months follow-up
Any riding/driving risk
Time frame: 12 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Derived from this study: PubMed 38530346Shrier LA, O'Connell MM, Torres A, Shone LP, Fiks AG, Plumb JA, Maturo JL, McCaskill NH, Harris D, Burke PJ, Felt T, Murphy ML, Sherritt L, Harris SK. Computer-Facilitated Screening and Brief Intervention for Alcohol Use Risk in Adolescent Patients of Pediatric Primary Care Offices: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2024 Mar 26;13:e55039. doi: 10.2196/55039.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sion K Harris, PhD principal investigator
Boston Children's Hospital
Lydia A Shrier, MD, MPH principal investigator
Boston Children's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-facilitated Screening and Brief Intervention in people with Heavy Drinking and Driving Under the Influence, run by Boston Children's Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any heavy episodic drinking day during past 3 months (time frame: 3 months follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04450966, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.