NCT02233946

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
871

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

March 11, 2021

Completed
Last Updated

March 11, 2021

Status Verified

February 1, 2021

Enrollment Period

3.4 years

First QC Date

August 19, 2014

Results QC Date

December 28, 2020

Last Update Submit

February 18, 2021

Conditions

Prevention Harmful Effects

Keywords

Substance AbusePreventionYouthAlcoholDrugs

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Time to First Post-visit Cannabis Use Day

    12-months follow-up

  • Past-3-month Riding Risk

    12 months follow-up

Study Arms (2)

screening w/ computer brief intervention

EXPERIMENTAL

screening with computer-facilitated brief intervention

Behavioral: computer-facilitated brief intervention

Screening with Treatment as Usual

NO INTERVENTION

Screening with Treatment as Usual

Interventions

computer-facilitated brief interventionBEHAVIORAL

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 w/ computer brief intervention

Eligibility Criteria

Age9 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Patient has already participated in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Boston Childrens Primary Care Center

Boston, Massachusetts, 02115, United States

Location

Longwood Pediatrics

Boston, Massachusetts, 02115, United States

Location

East Boston Neighborhood Health Center

East Boston, Massachusetts, 02128, United States

Location

Lexington Pediatrics

Lexington, Massachusetts, 02421, United States

Location

Related Publications (1)

  • 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.

    PMID: 22566420BACKGROUND

Related Links

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Limitations and Caveats

Same practitioners delivering both the CSBI and UC may have contaminated UC arm; only group difference we could assure was the CRAFFT screen. Relied on patients' reporting of intervention; did not obtain independent observations of practitioner behaviors. Relied on self-report. Unable to examine effects on use of certain drugs (low prevalence). Did not collect parents' views of CSBI system.

Results Point of Contact

Title
Dr. Sion Kim Harris
Organization
Boston Children's Hospital
sion.harris@childrens.harvard.edu
8572184304

Study Officials

  • John R Knight, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

  • Sion K Harris, PhD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Director, Center for Adolescent Substance Abuse Research

Study Record Dates

First Submitted

August 19, 2014

First Posted

September 9, 2014

Study Start

January 1, 2015

Primary Completion

May 31, 2018

Study Completion

May 31, 2018

Last Updated

March 11, 2021

Results First Posted

March 11, 2021

Record last verified: 2021-02

Locations

US(5)