Alcohol Related DisordersNCT01544218
Validating NIAAA Screen Guide in YCMC
An observational study of Alcohol Related Disorders, run by Boston Children's Hospital at 1 site in United States.
Trial summary
Alcohol use is a serious health threat to the 26% youth in the US with chronic medical conditions. While alcohol use can significantly impact an underlying illness and its safe/effective management, medical specialists rarely screen their adolescent patients for alcohol use. Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- Alcohol Related Disorders
- How many people
- 521 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to 30 Jun 2016
- 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 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 9-18 year old youth with one of four chronic conditions - asthma, diabetes, rheumatic or gastroenterologic conditions
Who may be able to join
- 9-18 years of age
- duration of chronic illness of at least one year
- ability to speak/read English and use a computer keyboard and/or complete an interviewer-assisted questionnaire
Who cannot join
- medically or emotionally unstable
- unable to assent/consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: Validating NIAAA's Brief Screening Guide in Youth With Chronic Medical Conditions
Alcohol use is a serious health threat to the 26% youth in the US with chronic medical conditions. While alcohol use can significantly impact an underlying illness and its safe/effective management, medical specialists rarely screen their adolescent patients for alcohol use. The investigators will validate a new, brief alcohol- screening tool with 9-18 year old youth with chronic medical conditions. Comprehensive assessment information will be collected and analyzed to describe relationships between youth alcohol use, other substance use, and chronic disease outcomes and findings integrated into the validated screen as actionable clinician guidance and health advice.
- Conditions
- Alcohol Related Disorders
- Keywords
- Alcohol related disorders
- Medical subject headings
- Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| YCMC | Youth ages 9-18 with one of four chronic medical conditions - asthma, diabetes, rheumatic or gastroenterologic conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
eGuide diagnosis of alcohol use disorder
We will evaluate the sensitivity and specificity of the eGuide to correctly identify the group of YCMC who have problem use/abuse or dependence, using the CIDI-SAM as the criterion standard.
Measured: Baseline
Secondary outcomes (4)
Correlation of HgbA1c level with level of alcohol use
Measured: Baseline
Correlation between score on the Asthma Control Test (ACT)and level of alcohol use
Measured: Baseline
Correlation of score on The Childhood Health Assessment Questionnaire (CHAQ) with level of alcohol use
Measured: baseline
Correlation between The Pediatric Ulcerative Colitis Activity Index (PUCAI)score and level of alcohol use
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startSep 2012
- Primary completion20 Jul 2015
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Related DisordersStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 521 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharon Levy, Boston Children's Hospital
- Investigators
- Sharon Levy, MD, MPH, Principal investigator, Boston Children's HospitalElissa Weitzman, ScD, MSc, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544218
- Sponsor's protocol ID
- SL_NIAAARFA_0212
- Status last verified
- Jun 2017
- First submitted
- 15 Feb 2012
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating NIAAA's Brief Screening Guide in Youth With Chronic Medical Conditions
- ClinicalTrials.gov ID
- NCT01544218
- Acronym / sponsor ID
- SL_NIAAARFA_0212
- Conditions
- Alcohol Related Disorders
- Keywords
- Alcohol related disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 521 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- 20 Jul 2015 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 5 Mar 2012 (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.
Alcohol use is a serious health threat to the 26% youth in the US with chronic medical conditions. While alcohol use can significantly impact an underlying illness and its safe/effective management, medical specialists rarely screen their adolescent patients for alcohol use. The investigators will validate a new, brief alcohol- screening tool with 9-18 year old youth with chronic medical conditions. Comprehensive assessment information will be collected and analyzed to describe relationships between youth alcohol use, other substance use, and chronic disease outcomes and findings integrated into the validated screen as actionable clinician guidance and health advice.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YCMC | – | –Youth ages 9-18 with one of four chronic medical conditions - asthma, diabetes, rheumatic or gastroenterologic conditions |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 9-18 year old youth with one of four chronic conditions - asthma, diabetes, rheumatic or gastroenterologic conditions
Key inclusion criteria (3 listed)
- 9-18 years of age
- duration of chronic illness of at least one year
- ability to speak/read English and use a computer keyboard and/or complete an interviewer-assisted questionnaire
Key exclusion criteria (2 listed)
- medically or emotionally unstable
- unable to assent/consent
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
eGuide diagnosis of alcohol use disorder
Time frame: Baseline
We will evaluate the sensitivity and specificity of the eGuide to correctly identify the group of YCMC who have problem use/abuse or dependence, using the CIDI-SAM as the criterion standard.
4 secondary outcomes
Correlation of HgbA1c level with level of alcohol use
Time frame: Baseline
Correlation between score on the Asthma Control Test (ACT)and level of alcohol use
Time frame: Baseline
Correlation of score on The Childhood Health Assessment Questionnaire (CHAQ) with level of alcohol use
Time frame: baseline
Correlation between The Pediatric Ulcerative Colitis Activity Index (PUCAI)score and level of alcohol use
Time frame: Baseline
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 21 Jun 2017.
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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
Elissa Weitzman, ScD, MSc 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 Alcohol Related Disorders, 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 2 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 21 Jun 2017. 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?
eGuide diagnosis of alcohol use disorder (time frame: Baseline). 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 21 Jun 2017; AzTrials last refreshed its copy on 30 Oct 2026.