NCT02387489

Brief Summary

The purpose of the study is to examine the comparative effectiveness of a computerized brief intervention vs. an in-person brief intervention delivered by a nurse in reducing marijuana, alcohol, and sex risk behaviors in adolescents receiving services in school-based health centers.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 13, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

October 2, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2018

Completed
Last Updated

November 15, 2018

Status Verified

November 1, 2018

Enrollment Period

2.9 years

First QC Date

March 4, 2015

Last Update Submit

November 13, 2018

Conditions

Marijuana UseAlcohol ConsumptionUnsafe SexRisk Behavior

Outcome Measures

Primary Outcomes (1)

  • frequency of marijuana use

    days of marijuana use in the past 30 days

    3 months; 6 months

Secondary Outcomes (6)

  • frequency of alcohol use

    3 months; 6 months

  • binge drinking

    3 months; 6 months

  • Marijuana Risks

    3 months; 6 months

  • Alcohol Risks

    3 months; 6 months

  • Unprotected sex

    3 months; 6 months

  • +1 more secondary outcomes

Other Outcomes (1)

  • Assessment/treatment entry

    3 months; 6 months

Study Arms (2)

NBI

ACTIVE COMPARATOR

Nurse-delivered Brief Intervention

Behavioral: Brief in-person motivational intervention

CBI

EXPERIMENTAL

Computerized Brief Intervention

Behavioral: Computerized Brief Intervention

Interventions

Brief in-person motivational interventionBEHAVIORAL

Brief in-person motivational intervention tailored to participants' risk behaviors, delivered by a nurse.

NBI
Computerized Brief InterventionBEHAVIORAL

Computer-delivered motivational intervention tailored to participants' risk behaviors.

CBI

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patient seen at one of the participating school-based health centers
  • Self-reported marijuana or alcohol use (on CRAFFT screener)
  • CRAFFT score of 2 or higher

You may not qualify if:

  • use of illicit drugs, or non-medical use of prescription drugs, other than marijuana, alcohol, or tobacco (as self-reported on CRAFFT screener)
  • current enrollment in substance abuse treatment
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Marijuana UseAlcohol DrinkingUnsafe SexRisk-Taking

Condition Hierarchy (Ancestors)

BehaviorSubstance-Related DisordersMental DisordersDrinking BehaviorSexual Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2015

First Posted

March 13, 2015

Study Start

October 2, 2015

Primary Completion

September 11, 2018

Study Completion

September 11, 2018

Last Updated

November 15, 2018

Record last verified: 2018-11