NCT02981849

Brief Summary

The purpose of this study is to address the needs for efficient and informative measurement for evaluating adolescent Screening, Brief Intervention, and Referral to Treatment (SBIRT) strategies. The investigators will undertake a longitudinal cohort study to build and validate a substance specific measurement battery that includes patient-centered and intermediary outcomes which can be integrated into a range of healthcare and research settings. The results of this project will enable evaluation of SBIRT trials and clinical efforts by validating a parsimonious set of measurement tools that can be incorporated into electronic health records. The primary goal of the proposed project is to develop a set of brief, valid tools that will allow both researchers and clinicians to collect information that enables evaluating and refining brief interventions. The main objective is to define and disseminate a set of brief and easy to administer measures that accurately detect 1) substance use frequency, 2) substance-specific patient centered outcomes and 3) intermediate measures of impact of adolescent SBIRT. The specific aim addressed in this project is to develop and administer an assessment battery that includes novel questions assessing substance use to be validated against criterion standard measures both cross-sectionally and longitudinally.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
514

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2016

Completed
9 months until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

3.2 years

First QC Date

March 17, 2016

Last Update Submit

January 22, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Validation of adolescent substance use measures

    This is a validation project. We aim to validate a single question regarding the frequency of substance against the criterion standard timeline followback calendar

    Past year

  • Predictive behaviors that indicate a change in substance use frequency

    Change in substance use frequency at 1 year

    1 year

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Adolescent, ages 14-17, receiving care at the Adolescent/Young Adult Medicine Clinic at Boston Children's Hospital

You may qualify if:

  • year-old youth presenting for routine medical care at the Adolescent and Young Adult clinic at BCH, with informed assent/consent.
  • To be eligible, youth must be between 14-17 years old at the time of enrollment and be able to read and understand English at a middle school level or greater.
  • Participants must consent to participation in the study and consent to the 6 month and 12 month follow up assessments.

You may not qualify if:

  • Patients who are medically or emotionally unstable or otherwise unable to assent/consent at the time of their appointment as determined by their clinician or the research team, those who are unable to speak/read English at a middle school reading level, use a computer keyboard and/or complete an interviewer-assisted questionnaire will be excluded.
  • Participants who do not consent to 6 month and 12 month re-assessment will also be excluded.
  • Patients who are pregnant at baseline will be excluded from the study.
  • If a participant enrolls in the study and becomes pregnant after baseline, the participant will not be excluded from the follow up assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Sharon Levy, MD, MPH

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

March 17, 2016

First Posted

December 5, 2016

Study Start

January 1, 2016

Primary Completion

March 1, 2019

Study Completion

December 1, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations