Computer-based Intervention for Adolescent Alcohol Abuse

(ASPIRE Trial)

Not currently recruiting at 2 trial locations

Overseen By Lydia A Shrier, MD, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Disqualifiers: Foster care, Non-English, Specialty treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a computer-based tool to help doctors discuss alcohol use and safety with teens when riding or driving. The tool, known as Computer-facilitated Screening and Brief Intervention (cSBI), aims to reduce risky drinking behaviors among teens. Doctors will be divided into two groups: one will use the new tool, while the other will continue with their usual care. Teens aged 14-17 who have tried alcohol or been in a car with an impaired driver might be suitable participants. They need to have their own cell phone and complete a few activities before their doctor’s visit. As an unphased trial, this study offers teens a unique opportunity to contribute to innovative approaches in healthcare communication.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this computer-facilitated screening and brief intervention is safe for adolescents?

Research has shown that computer-based Screening and Brief Intervention (cSBI) systems are generally safe for teenagers. This method uses a computer program to assist doctors in discussing alcohol use with teens. Studies have found that this approach effectively engages young people without causing harm. For example, a large study with teenagers found that both doctors and patients appreciated the cSBI system, and no major negative effects were reported. The system guides conversations and supports doctors in explaining the risks of alcohol to teens. Overall, this treatment appears well-accepted by those who have tried it in past research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the computer-facilitated screening and brief intervention (cSBI) for adolescent alcohol abuse because it offers a unique, tech-based approach to intervention. Unlike traditional methods that often rely on face-to-face counseling, cSBI leverages technology to facilitate early screening and intervention, making it more accessible and less intimidating for teens. This method can be easily integrated into various settings, such as schools or clinics, allowing for broader reach and potentially earlier intervention. By using a digital platform, cSBI aims to engage adolescents in a familiar environment, which could enhance participation and effectiveness.

What evidence suggests that the computer-facilitated Screening and Brief Intervention is effective for adolescent alcohol abuse?

Research has shown that using computers to help screen and briefly intervene (cSBI) can effectively reduce unhealthy alcohol use among teenagers. In this trial, participants will divide into two groups: one will receive the usual care, while the other will receive the experimental cSBI intervention. Studies have found that these cSBI methods successfully lower drinking levels in young people. The CRAFFT screening test, often used in these methods, effectively identifies substance issues, with an 80% chance of correctly finding those who have problems and an 86% chance of correctly identifying those who don't. These findings suggest that cSBI could be a promising tool for addressing alcohol-related risks in teenagers. ^{1 2 6 7 8}

Who Is on the Research Team?

Lydia A. Shrier, MD

Principal Investigator

Boston Children's Hospital

Sion K Harris, PhD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

This trial is for teens aged 14-17 who have used alcohol in the past year or ridden with an impaired driver. They must be going for a check-up, able to complete activities before their visit, and willing to share their cell phone number. Teens already in substance use treatment, with communication barriers, or certain medical/emotional issues can't join.

Inclusion Criteria

Presenting for well-visit with participating clinician

Has own cell phone and is willing to share cell phone number before their scheduled visit

I am between 14 and 17 years old.

Exclusion Criteria

Unable to read and communicate in English

Youth in foster care

I cannot commit to attending all follow-up visits.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Intervention

Participants receive computer-facilitated Screening and Brief Intervention (cSBI) during well-visits

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for heavy episodic drinking and riding/driving risks

12 months

Periodic surveys

What Are the Treatments Tested in This Trial?

Interventions

• Computer-facilitated Screening and Brief Intervention

Trial Overview

The study tests a computer-assisted system that helps doctors talk to teens about alcohol use and safe riding/driving practices during regular check-ups. It's part of a large trial across many U.S. clinics aiming to reduce teen alcohol abuse and improve safety on the roads.

How Is the Trial Designed?

Group I: Computer-facilitated screening and brief intervention Experimental Treatment 1 Intervention

Clinicians randomized to this arm will receive training in delivery of cSBI and their participating patients will then receive the experimental intervention.

Group II: Usual Care Active Control 1 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.

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

American Academy of Pediatrics

Collaborator

Trials

46

Recruited

4,071,000+

Published Research Related to This Trial

The article discusses interactive, computer-based programs designed for substance abuse prevention and treatment among adolescents, highlighting their effectiveness in promoting health behavior changes.

These programs are based on scientific principles and utilize evidence-based technologies, making them engaging and suitable for widespread use, which can enhance their accessibility and cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of interactive, computer technology to adolescent substance abuse prevention and treatment. Marsch, LA., Bickel, WK., Grabinski, MJ.[2008]

Computer-based drinking assessment and intervention programs have been evaluated in the general public, revealing that users are typically young males in their early 30s who are at risk for alcohol-related issues.

While dropout rates from these online interventions are high, those who complete the programs generally show improvements in their drinking behaviors, indicating potential efficacy for those who engage fully.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of computer-based alcohol problem services designed for the general public. Vernon, ML.[2022]

Recent studies on computer-based programs for preventing substance use among youth show mixed results, with many suffering from high dropout rates, which affects the reliability of their findings.

The most effective programs are those specifically designed for targeted youth populations, but there is a lack of such tailored interventions, indicating a need for more customized approaches in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-Based Prevention and Intervention to Reduce Substance Use in Youth. Schinke, S., Schwinn, TM.[2022]

In a 6-month study at a 140-bed community hospital, a computer-based alerting system generated 3547 alerts, with 528 classified as high or critical priority, indicating its potential to identify serious medication-related issues.

The review of high-priority alerts revealed that approximately 37 adverse drug events (ADEs) could be prevented annually, demonstrating the system's effectiveness in mitigating medication toxicity through timely clinical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug event detection in a community hospital utilising computerised medication and laboratory data. Seger, AC., Jha, AK., Bates, DW.[2018]

A Web-based brief alcohol intervention effectively reduced weekly drinking among binge drinkers aged 15 to 20, with significant results observed at both 1 and 3 months after the intervention.

The intervention was particularly effective for males, who showed decreased alcohol use and increased moderate drinking, while females did not experience the same benefits, indicating a need for tailored approaches in alcohol interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a web-based brief alcohol intervention and added value of normative feedback in reducing underage drinking: a randomized controlled trial. Spijkerman, R., Roek, MA., Vermulst, A., et al.[2021]

A review of pediatric psychopharmacology trials over the past 10 years revealed that only 11.8% utilized a data and safety monitoring board (DSMB), indicating a significant gap in safety monitoring practices for this vulnerable population.

Most trials relied on basic safety elicitation methods, such as laboratory tests and vital signs, with only 6% depending solely on spontaneous reporting of adverse events, highlighting the need for improved safety protocols in pediatric research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety methodology in pediatric psychopharmacology trials. Yuill, K., Carandang, C.[2013]

A new computer-based system has been developed for managing reports of adverse drug reactions and serious adverse events, featuring a network of three regional centers and a central database for efficient data handling.

This system is designed to be secure, reliable, and cost-effective, making it a potential model for future clinical health information networks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Putting the pieces together: using "off-the-shelf" software to safely transfer medical data. Swoboda, WJ., Göttler, M., Zinnhobler, K., et al.[2017]

A Web-based system was successfully designed to track adverse and near-miss events in surgical patients, identifying 957 adverse events from 15,524 reported cases, which highlights the need for better reporting practices among physicians.

The study revealed significant underreporting, with only 25% of complications and 42% of inpatient deaths reported, indicating a cultural issue in recognizing and documenting adverse events in surgical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an online morbidity, mortality, and near-miss reporting system to identify patterns of adverse events in surgical patients. Bilimoria, KY., Kmiecik, TE., DaRosa, DA., et al.[2022]

Computer-based tools for diagnosing and treating alcohol-related problems can improve accessibility and cost-effectiveness in clinical settings, making it easier for healthcare providers to implement these interventions.

Some computer-based programs have been shown to effectively motivate patients and reduce alcohol-related harm by teaching essential skills, highlighting their potential as valuable alternatives to traditional face-to-face treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-based tools for diagnosis and treatment of alcohol problems. Hester, RK., Miller, JH.[2020]

The computerized alcohol screening and intervention (CASI) kiosk was successfully implemented in an emergency department, screening 5103 patients and identifying 19% as at-risk or dependent drinkers, particularly among younger males.

Patients found the CASI easy to use, with over 75% preferring the computer-based intervention over a medical professional, indicating high acceptability and feasibility for alcohol screening and brief intervention in an ED setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of emergency department bilingual computerized alcohol screening, brief intervention, and referral to treatment. Vaca, F., Winn, D., Anderson, C., et al.[2015]

The computer-facilitated screening and brief advice (cSBA) intervention significantly reduced heavy episodic drinking (HED) among Czech adolescents in the short term, with a relative risk ratio of 0.52 at 3 months compared to treatment-as-usual (TAU).

However, the effectiveness of cSBA diminished by the 12-month mark, indicating that while it may be beneficial for short-term prevention of HED, longer-term strategies may be needed to sustain its impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-Facilitated Screening and Brief Advice to Reduce Adolescents' Heavy Episodic Drinking: A Study in Two Countries. Knight, JR., Kuzubova, K., Csemy, L., et al.[2019]

The REACH II program, a multi-site trial focused on caregivers of Alzheimer's patients, highlighted the need for tailored safety monitoring and adverse event reporting protocols in psychosocial and behavioral intervention studies, as existing guidelines primarily address medical interventions.

The study identified unique challenges in defining and classifying adverse events, as well as establishing resolution criteria, emphasizing the variability in safety monitoring practices across psychosocial trials and the necessity for standardized protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Data and safety monitoring in social behavioral intervention trials: the REACH II experience. Czaja, SJ., Schulz, R., Belle, SH., et al.[2022]

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