NCT01454206

Brief Summary

The Goal of this project is to integrate a previously-tested internet-facilitated Screening, Brief Intervention, and Referral to Treatment (iSBIRT) system for adolescent substance use into a large network of primary care offices, the Pediatric Practices of Children's Hospital Boston (PPOC).

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

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

October 5, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 18, 2011

Completed
9 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 7, 2016

Status Verified

October 1, 2016

Enrollment Period

4.3 years

First QC Date

October 5, 2011

Last Update Submit

October 6, 2016

Conditions

Keywords

cannabis abusealcohol abusesubstance abuse

Outcome Measures

Primary Outcomes (1)

  • Provider attitude toward iSBIRT

    We will evaluate providers' acceptance of and attitude toward integrating iSBIRT into their practices.

    12 months post baseline

Secondary Outcomes (5)

  • Youth connectedness to provider

    Baseline

  • iSBIRT sustainability

    12 months post

  • Change in rates of adolescent substance use

    3 months post baseline

  • Change in rates of adolescent substance use

    6 months post baseline

  • Change in rates of adolescent substance use

    12 months post baseline

Study Arms (2)

Treatment as Usual

NO INTERVENTION

iSBIRT

EXPERIMENTAL

Participants will receive the internet-facilitated screening, brief intervention and referral to treatment (iSBIRT intervention)

Behavioral: iSBIRT

Interventions

iSBIRTBEHAVIORAL

Participants will be screened for substance use, view information about the health effects of substance use on the computer, and receive advice from the primary care provider regarding the health effects of substance use. Those found to be at "high risk" will complete an internet-based program encouraging them to change their substance use.

iSBIRT

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • year olds
  • Coming for non-emergent care
  • Access to a private computer
  • Have email address

You may not qualify if:

  • Not available for follow-up questionnaires
  • Unable to read or understand English at a 6th grade reading level
  • Medically or emotionally unstable on the day of the visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related Links

MeSH Terms

Conditions

Substance-Related DisordersMarijuana AbuseAlcoholism

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersAlcohol-Related Disorders

Study Officials

  • John R Knight, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics, Harvard Medical School; Senior Associate in Medicine; Associate in Psychiatry, Director, Center for Adolescent Substance Abuse Research, Boston Children's Hospital

Study Record Dates

First Submitted

October 5, 2011

First Posted

October 18, 2011

Study Start

July 1, 2012

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

October 7, 2016

Record last verified: 2016-10

Locations