Clinical trial NCT02233946: Computerized Alcohol Screening for Children and Adolescents (cASCA) in Primary Care
Official title: Computerized Alcohol Screening for Children and Adolescents (cASCA) in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevention Harmful Effects
Keywords: Substance Abuse
Prevention
Youth
Alcohol
Drugs
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2014-09-09
Enrollment: 871
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the psychometric properties of a brief screening questionnaire for alcohol problems among 9- to 18-year-old patients in pediatricians' offices, and to pilot test a personalized, computer-facilitated brief intervention delivered on a tablet computer and by the provider based on screening results.

Detailed description: The primary goal of this project is to develop a computerized screening program for primary care offices that is based on the NIAAA's new Alcohol Screening Guide for Children and Adolescents and assess its psychometric properties among nine- to 18-yr-old primary care patients. There is substantial evidence supporting the effectiveness of screening and brief intervention among adult primary care patients, primarily in the reduction of harmful drinking. However, there have been few studies of alcohol screening and brief intervention conducted among adolescents seen in busy primary care settings. This project will develop and validate a new computerized Alcohol Screening for Children and Adolescents (cASCA) program which incorporates the age-specific screening questions of the NIAAA Guide and includes the CRAFFT and AUDIT as secondary risk/problem assessments. We will add tobacco screening because tobacco use is the leading cause of cancer-related mortality in the US as well as screening for marijuana and other drug use so as to create a comprehensive screening instrument that includes all major substances that adolescents use.

Additionally, the NIAAA guide recommends that providers deliver a brief intervention in response to the screening results. Therefore, a secondary aim of this project will be to pilot-test a computer-facilitated Brief Intervention component using a randomized design comparing three groups: 1) screening with treatment as usual \[cASCA/TAU\]; 2) screening with the computer-facilitated brief intervention \[cASCA/BI\]. The BI component consists of patients viewing on the computer, immediately after the screening, their score and level of risk for a substance use problem, as well as several interactive pages of science and true-life stories about the health risks of substance use. Clinicians are then given the screen results and suggested talking points for a few minutes of brief counseling during the visit.

Hypothesis: Among 9- to 18-year-old primary care patients, those receiving cASCA/BI will have lower rates of any alcohol use, days of alcohol use, drinks per drinking day, and days of heavy episodic drinking, at 3, 6, 9 and 12-months follow-up than those receiving treatment as usual.

Eligibility criteria: Inclusion Criteria:

* access to computer and email address
* available and willing to complete all follow ups by email or phone
* medically and emotionally stable
* can read and understand English

Exclusion Criteria:

* Patient has already participated in this study

Primary outcomes:
measure: Time to First Post-visit Drinking Day
timeFrame: 12-months follow-up
measure: Time to First Post-visit Heavy Episodic Drinking Day
timeFrame: 12-months follow-up
Secondary outcomes:
measure: Time to First Post-visit Cannabis Use Day
timeFrame: 12-months follow-up
measure: Past-3-month Riding Risk
timeFrame: 12 months follow-up
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Boston Childrens Primary Care Center
state: Massachusetts
city: Boston
country: United States
facility: Longwood Pediatrics
state: Massachusetts
city: East Boston
country: United States
facility: East Boston Neighborhood Health Center
state: Massachusetts
city: Lexington
country: United States
facility: Lexington Pediatrics
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: John R Knight, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Children's Hospital
name: Sion K Harris, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harris SK, Csemy L, Sherritt L, Starostova O, Van Hook S, Johnson J, Boulter S, Brooks T, Carey P, Kossack R, Kulig JW, Van Vranken N, Knight JR. Computer-facilitated substance use screening and brief advice for teens in primary care: an international trial. Pediatrics. 2012 Jun;129(6):1072-82. doi: 10.1542/peds.2011-1624. Epub 2012 May 7.