Computer-based Intervention for Adolescent Alcohol Abuse
(ASPIRE Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Boston Children's Hospital
Disqualifiers: Foster care, Non-English, Specialty treatment, others
No Placebo Group
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.
12345Is 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.
678910How 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.
1231112Eligibility 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.Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Computer-facilitated screening and brief interventionExperimental Treatment1 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 CareActive Control1 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.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
American Academy of PediatricsItasca, IL
Boston Children's HospitalBoston, MA
Children's Hospital of PhiladelphiaPhiladelphia, PA
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Who is running the clinical trial?
Boston Children's HospitalLead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Collaborator
Children's Hospital of PhiladelphiaCollaborator
American Academy of PediatricsCollaborator
References
Computer-based tools for diagnosis and treatment of alcohol problems. [2020]Diagnosis and treatment of alcohol-related problems are time-intensive procedures that often are difficult to implement in busy clinical settings. Computer-based tools are one approach that may enhance the availability and cost-effectiveness of assessment and intervention and also may offer other advantages over face-to-face interventions. Several PC- and Internet-based programs have been developed that can be used for assessing alcohol problems, some of which are based on existing screening instruments. Other programs have demonstrated effectiveness as interventions, serving to increase patient motivation and reduce alcohol-associated harm through skill building. Investigators also have begun to analyze the mechanisms through which computer-based programs can induce these effects. Future efforts should be aimed at developing and evaluating additional computer-based interventions, particularly for specific patient subgroups, and at removing barriers to the incorporation of such programs into clinical practice.
Computer-Based Prevention and Intervention to Reduce Substance Use in Youth. [2022]Computer-based programs for substance use prevention and intervention among youth are on the ascendancy. Whether delivered by computer per se or by electronic tablet or smartphone, technology-driven programs are harmonious with how young people access information and interact with their worlds. This review examines recent evidence on computer-based programs aimed at substance use among youth, with particular attention to results from randomized trials.
A review of computer-based alcohol problem services designed for the general public. [2022]This review summarizes the literature on computer-based drinking assessment and intervention programs evaluated using members of the general public. The primary aim was to summarize the demand, usage, and effectiveness of these services. A systematic search of the literature identified seven online drinking assessments and eight computerized interventions that were evaluated using members of the general public. Internet assessment users tend to be in their early 30s, are more often male, tend to be at risk for or are experiencing alcohol-related problems, more fully explore assessment sites, and are more likely to enroll in interventions linked to these sites when their drinking problem is more severe. Although dropout from computer-based interventions is often very high and treatment models vary widely, program completers appear to show improvements.
Computer-Facilitated Screening and Brief Advice to Reduce Adolescents' Heavy Episodic Drinking: A Study in Two Countries. [2019]A computer-facilitated screening and brief advice (cSBA) intervention was previously shown to reduce drinking among U.S. adolescents but not among Czech youth. The purpose of this study was to assess cSBA effect on heavy episodic drinking (HED).
Feasibility of emergency department bilingual computerized alcohol screening, brief intervention, and referral to treatment. [2015]The purpose of this study was to assess the feasibility of utilizing a computerized alcohol screening and intervention (CASI) kiosk in an emergency department (ED). An interactive English and Spanish audiographical computer program, developed for used on a mobile computer cart, was administered to 5103 patients. Patients who screened at risk (19%) also received a fully computer-guided brief negotiated interview (BNI) and a printed personal alcohol reduction plan. A higher percentage of younger patients, and males (31% versus 16% females), screened at risk or dependent. Patient surveys indicated CASI was easy to use and over 75% did not prefer a medical professional over the computer. The ED-based bilingual computerized alcohol screening, brief intervention, and referral to treatment required little time to administer, was acceptable to patients, identified at-risk and dependent drinkers, and was able to provide personalized feedback and brief intervention.
Adverse drug event detection in a community hospital utilising computerised medication and laboratory data. [2018]Computerised monitors can detect and, with clinical intervention, often prevent or ameliorate adverse drug events (ADEs). We evaluated whether a computer-based alerting system was useful in a community hospital setting.
Putting the pieces together: using "off-the-shelf" software to safely transfer medical data. [2017]We describe a new computer-based, network-driven system for administering, transferring, and evaluating reports of spontaneous adverse drug reactions and serious adverse events. The system consists of three regional centers, one coordinating center, and a central database at the national drug regulatory authority. In view of its high level of data security, reliability, easy expandability, and inexpensiveness due to the use of standard shareware products, the system can serve as a model for a clinical health information network.
Safety methodology in pediatric psychopharmacology trials. [2013]In recent years, there has been an increase in pediatric clinical trials as the result of an identified need for greater research with this population. Given the potential risks, and the vulnerability of the population, there has also been an identified need for greater safety elicitation and monitoring in pediatric psychopharmacology trials, for example, through the use of a data and safety monitoring board (DSMB). However, research indicates that pediatric trials and psychiatric trials are less likely to use a DSMB. The rationale for the current study was to determine what safety methodologies have been reported in pediatric psychopharmacology trials over the past 10 years. A literature review was conducted of all pediatric psychopharmacology trials published since 2001. Results indicated that the most common elicitation method was collecting laboratory information and vital signs. Six percent of trials solely relied on spontaneous reporting of adverse events, and only 11.8% reported using a DSMB. These results suggest that elicitation methods and use of DSMBs are still low. Practical considerations, affected stakeholders, and barriers are discussed. Recommendations for moving forward include the use of multiple elicitation methods and automatic requirement of a DSMB for pediatric psychopharmacology trials, required completion of a standardized safety reporting form, and engaging multiple interested parties in these processes.
Data and safety monitoring in social behavioral intervention trials: the REACH II experience. [2022]Psychosocial and behavioral interventions trials targeting a broad range of complex social and behavioral problems such as smoking, obesity and family caregiving have proliferated in the past 30 years. At the same time the use of Data and Safety Monitoring Boards (DSMBs) to monitor the progress and quality of intervention trials and the safety of study participants has increased substantially. Most of the existing literature and guidelines for safety monitoring and reporting of adverse events focuses on medical interventions. Consequently, there is little guidance for investigators conducting social and behavior trials.
Development of an online morbidity, mortality, and near-miss reporting system to identify patterns of adverse events in surgical patients. [2022]To design a Web-based system to track adverse and near-miss events, to establish an automated method to identify patterns of events, and to assess the adverse event reporting behavior of physicians.
Effectiveness of a web-based brief alcohol intervention and added value of normative feedback in reducing underage drinking: a randomized controlled trial. [2021]Current insights indicate that Web-based delivery may enhance the implementation of brief alcohol interventions. Previous research showed that electronically delivered brief alcohol interventions decreased alcohol use in college students and adult problem drinkers. To date, no study has investigated the effectiveness of Web-based brief alcohol interventions in reducing alcohol use in younger populations.
Application of interactive, computer technology to adolescent substance abuse prevention and treatment. [2008]This article provides an overview of several interactive, computer-based substance abuse-prevention and -treatment interventions that we have developed for adolescents, including an interactive substance abuse-prevention multimedia program for middle school-aged youth and a customizable program focused on prevention of HIV, hepatitis, and sexually transmitted infections among youth in substance abuse treatment. The content in these programs is grounded in a scientific understanding of the types of skills and information that are critical to effective prevention. The programs also use several evidence-based informational technologies that have been shown to be critical in effectively training key skills and information. Our evaluations to date have underscored the effectiveness of these programs in producing desired health-behavior change. Applying information technologies to the delivery of science-based interventions may allow for unique opportunities to provide widespread dissemination of cost-effective interventions with consistency and in a manner that is engaging and acceptable to youth.