Computer-based Intervention for Adolescent Alcohol Abuse

(ASPIRE Trial)

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

406 Participants Needed

Trial Summary

What is the purpose of this 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.

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 data supports the effectiveness of the treatment Computer-facilitated Screening and Brief Intervention (cSBI) for adolescent alcohol abuse?

Research shows that computer-based programs can effectively increase motivation and reduce alcohol-related harm by building skills. A study found that a similar computer-facilitated intervention reduced heavy drinking among U.S. adolescents, indicating potential effectiveness for this treatment. ^{1 2 3 4 5}

Is the computer-based intervention for adolescent alcohol abuse safe for humans?

There is no specific safety data available for the computer-based intervention for adolescent alcohol abuse, but general safety monitoring practices in social and behavioral trials have increased, focusing on participant safety. ^{6 7 8 9 10}

How is the Computer-facilitated Screening and Brief Intervention (cSBI) treatment different from other treatments for adolescent alcohol abuse?

The Computer-facilitated Screening and Brief Intervention (cSBI) is unique because it uses computer technology to deliver interventions, making it more accessible and engaging for adolescents who are comfortable with digital platforms. This approach can enhance motivation and reduce alcohol-related harm by providing personalized feedback and skill-building exercises, which may be more cost-effective and easier to implement than traditional face-to-face interventions. ^{1 2 3 11 12}

Research Team

Lydia A. Shrier, MD

Principal Investigator

Boston Children's Hospital

Sion K Harris, PhD

Principal Investigator

Boston Children's Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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 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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Computer-based tools for diagnosis and treatment of alcohol problems. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Computer-Based Prevention and Intervention to Reduce Substance Use in Youth. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Computer-Facilitated Screening and Brief Advice to Reduce Adolescents' Heavy Episodic Drinking: A Study in Two Countries. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Feasibility of emergency department bilingual computerized alcohol screening, brief intervention, and referral to treatment. [2015]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Adverse drug event detection in a community hospital utilising computerised medication and laboratory data. [2018]

7. Germany pubmed.ncbi.nlm.nih.gov

Putting the pieces together: using "off-the-shelf" software to safely transfer medical data. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Safety methodology in pediatric psychopharmacology trials. [2013]

9. England pubmed.ncbi.nlm.nih.gov

Data and safety monitoring in social behavioral intervention trials: the REACH II experience. [2022]

10. United States 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. [2022]

11. Canada 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. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Application of interactive, computer technology to adolescent substance abuse prevention and treatment. [2008]