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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01454206
Other study ID # CeASAR app RFADA12008
Secondary ID
Status Withdrawn
Phase Phase 2/Phase 3
First received October 5, 2011
Last updated October 6, 2016
Start date July 2012
Est. completion date December 2016

Study information

Verified date October 2016
Source Boston Children’s Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2016
Est. primary completion date October 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria:

- 12-18 year olds

- Coming for non-emergent care

- Access to a private computer

- Have email address

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
iSBIRT
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.

Locations

Country Name City State
United States Children's Hospital Boston Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Provider attitude toward iSBIRT We will evaluate providers' acceptance of and attitude toward integrating iSBIRT into their practices. 12 months post baseline No
Secondary Youth connectedness to provider We will measure adolescents' attitudes toward their providers' advice regarding the health effects of substance use given during the visit Baseline No
Secondary iSBIRT sustainability We will measure rates of continued use of iSBIRT by practices 12 months after iSBIRT recruitment and implementation ends 12 months post No
Secondary Change in rates of adolescent substance use We will measure the change in rates of adolescent substance use from baseline to 3 months post study visit. 3 months post baseline No
Secondary Change in rates of adolescent substance use We will measure the change in rates of adolescent substance use from baseline to 6 months post study visit. 6 months post baseline No
Secondary Change in rates of adolescent substance use We will measure the change in rates of adolescent substance use from baseline to 12 months post study visit. 12 months post baseline No
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