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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02233946
Other study ID # P00004862
Secondary ID 1R01AA021904-01
Status Completed
Phase N/A
First received
Last updated
Start date January 2015
Est. completion date May 31, 2018

Study information

Verified date February 2021
Source Boston Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 871
Est. completion date May 31, 2018
Est. primary completion date May 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
computer-facilitated brief intervention
Immediate feedback to patient of screening results and risk for substance use problem, followed by 11 pages of science and true-life stories about health risks of adolescent substance use. Screening results then go to provider who reviews them with patient and gives brief counseling, and refers to an online motivational enhancement therapy intervention for patients at moderate/high risk for substance use problems.

Locations

Country Name City State
United States Boston Childrens Primary Care Center Boston Massachusetts
United States Longwood Pediatrics Boston Massachusetts
United States Tufts Medical Center Boston Massachusetts
United States East Boston Neighborhood Health Center East Boston Massachusetts
United States Lexington Pediatrics Lexington Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Boston Children's Hospital National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Harris SK, Csémy 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Time to First Post-visit Drinking Day Median (and interquartile range) for times to first use for the cSBI and Treatment As Usual (TAU) groups 12-months follow-up
Primary Time to First Post-visit Heavy Episodic Drinking Day The number of days post-visit to first reported heavy episodic drinking day 12-months follow-up
Secondary Time to First Post-visit Cannabis Use Day The number of days post-visit to first reported cannabis use day. 12-months follow-up
Secondary Past-3-month Riding Risk Self-reported riding in the past 3 months with a driver who had been drinking or using other drugs, stratified by reported riding risk in the past 3 months at baseline 12 months follow-up
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