Substance AbuseNCT02981849
Validating Adolescent SBIRT Measures
An observational study of Substance Abuse, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse
- How many people
- 514 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Adolescent, ages 14-17, receiving care at the Adolescent/Young Adult Medicine Clinic at Boston Children's Hospital
Who may be able to join
- 14-17 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the detailed description
A policy level mandate now exists to deliver screening, brief intervention, and referral to treatment (SBIRT) to all adolescents in primary care. This mandate is spurred by the imperative to reduce the enormous and preventable morbidity and mortality caused by adolescent substance use. Despite this mandate and the opportunity to reach large cohorts of youth early within primary and specialty pediatric care, SBIRT is not routinely delivered nor used in ways that optimize outcomes. The National Institute on Drug Abuse, National Institute on Alcoholism and Alcohol Abuse, the Substance Use and Mental Health Services Administration and the Hilton Foundation have all included adolescent SBIRT in their research, training and service project portfolios. Lacking validated measures that can be used to assess impacts and guide early action, opportunities to glean the most effective strategies and components of brief interventions are hampered despite these considerable investments. This threatens the relevance and sustainability of this work.
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. This is a construct validity study in which the investigators will be interested in seeing whether a brief set of questions will accurately measure substance use when compared to lengthy gold standard measures. This is also a predictive validity study, in which the investigators are interested in seeing whether proposed patient-centered and intermediary outcomes are relevant in predicting future substance use risk or patterns of use. 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.
This project is one component of a two part study in which the investigators will enroll a total of 900 adolescents. The investigators will enroll a total of 450 participants from the Adolescent/Young Adult Medical Clinic for this study and will attempt to follow participant for one year. Accounting for attrition at 6 months and 12 months follow-up, the investigators expect 300 participants will complete the entire study.
- Conditions
- Substance Abuse
- Medical subject headings
- Substance-Related Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Past year
Predictive behaviors that indicate a change in substance use frequency
Change in substance use frequency at 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startJan 2016
- Primary completionMar 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Conrad N. Hilton Foundation
- Responsible party
- Principal investigator, Sharon Levy, Boston Children's Hospital
- Investigators
- Sharon Levy, MD, MPH, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981849
- Sponsor's protocol ID
- P00019608
- Status last verified
- Jan 2020
- First submitted
- 17 Mar 2016
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating Adolescent SBIRT Measures
- ClinicalTrials.gov ID
- NCT02981849
- Acronym / sponsor ID
- P00019608
- Conditions
- Substance Abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 514 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Conrad N. Hilton Foundation
- Study start
- Jan 2016
- Primary completion
- Mar 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A policy level mandate now exists to deliver screening, brief intervention, and referral to treatment (SBIRT) to all adolescents in primary care. This mandate is spurred by the imperative to reduce the enormous and preventable morbidity and mortality caused by adolescent substance use. Despite this mandate and the opportunity to reach large cohorts of youth early within primary and specialty pediatric care, SBIRT is not routinely delivered nor used in ways that optimize outcomes. The National Institute on Drug Abuse, National Institute on Alcoholism and Alcohol Abuse, the Substance Use and Mental Health Services Administration and the Hilton Foundation have all included adolescent SBIRT in their research, training and service project portfolios. Lacking validated measures that can be used to assess impacts and guide early action, opportunities to glean the most effective strategies and components of brief interventions are hampered despite these considerable investments. This threatens the relevance and sustainability of this work.
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. This is a construct validity study in which the investigators will be interested in seeing whether a brief set of questions will accurately measure substance use when compared to lengthy gold standard measures. This is also a predictive validity study, in which the investigators are interested in seeing whether proposed patient-centered and intermediary outcomes are relevant in predicting future substance use risk or patterns of use. 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.
This project is one component of a two part study in which the investigators will enroll a total of 900 adolescents. The investigators will enroll a total of 450 participants from the Adolescent/Young Adult Medical Clinic for this study and will attempt to follow participant for one year. Accounting for attrition at 6 months and 12 months follow-up, the investigators expect 300 participants will complete the entire study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Adolescent, ages 14-17, receiving care at the Adolescent/Young Adult Medicine Clinic at Boston Children's Hospital
Key inclusion criteria (3 listed)
- 14-17 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validation of adolescent substance use measures
Time frame: Past year
This is a validation project. We aim to validate a single question regarding the frequency of substance against the criterion standard timeline followback calendar
Predictive behaviors that indicate a change in substance use frequency
Time frame: 1 year
Change in substance use frequency at 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Levy, MD, MPH principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Abuse, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of adolescent substance use measures (time frame: Past year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.