Computerized Alcohol Screening for Children and Adolescents (cASCA) in Primary Care

NCT ID: NCT02233946

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 871 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2018-05-31

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.

Conditions

Prevention Harmful Effects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

screening w/ computer brief intervention

screening with computer-facilitated brief intervention

Group Type: EXPERIMENTAL

computer-facilitated brief intervention

Intervention Type: BEHAVIORAL

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.

Screening with Treatment as Usual

Screening with Treatment as Usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sion Kim Harris

Co-Director, Center for Adolescent Substance Abuse Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John R Knight, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Sion K Harris, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Tufts Medical Center

Boston, Massachusetts, United States

Boston Childrens Primary Care Center

Boston, Massachusetts, United States

Longwood Pediatrics

Boston, Massachusetts, United States

East Boston Neighborhood Health Center

East Boston, Massachusetts, United States

Lexington Pediatrics

Lexington, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22566420 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.ceasar.org

Center for Adolescent Substance Abuse Research

Other Identifiers

1R01AA021904-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P00004862

Identifier Type: -

Identifier Source: org_study_id