Validating NIAAA Screen Guide in YCMC
This study is currently recruiting participants.
Verified January 2013 by Children's Hospital Boston
Sponsor:
Children's Hospital Boston
Information provided by (Responsible Party):
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01544218
First received: February 15, 2012
Last updated: January 2, 2013
Last verified: January 2013
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Purpose
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.
| Condition |
|---|
|
Alcohol Related Disorders |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Cross-Sectional |
| Official Title: | Validating NIAAA's Brief Screening Guide in Youth With Chronic Medical Conditions |
Resource links provided by NLM:
Further study details as provided by Children's Hospital Boston:
Primary Outcome Measures:
- eGuide diagnosis of alcohol use disorder [ Time Frame: Baseline ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Correlation of HgbA1c level with level of alcohol use [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Correlation between score on the Asthma Control Test (ACT)and level of alcohol use [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Correlation of score on The Childhood Health Assessment Questionnaire (CHAQ) with level of alcohol use [ Time Frame: baseline ] [ Designated as safety issue: No ]
- Correlation between The Pediatric Ulcerative Colitis Activity Index (PUCAI)score and level of alcohol use [ Time Frame: Baseline ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 460 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
YCMC
Youth ages 9-18 with one of four chronic medical conditions - asthma, diabetes, rheumatic or gastroenterologic conditions
|
Eligibility| Ages Eligible for Study: | 9 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
9-18 year old youth with one of four chronic conditions - asthma, diabetes, rheumatic or gastroenterologic conditions
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- medically or emotionally unstable
- unable to assent/consent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544218
Contacts
| Contact: Sharon Levy, MD | 857-218-4308 | sharon.levy@childrens.harvard.edu |
| Contact: Elissa Weitzman, ScD | 617-355-3538 | elissa.weitzman@childrens.harvard.edu |
Locations
| United States, Massachusetts | |
| Children's Hospital Boston | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Sharon Levy, MD 857-218-4308 sharon.levy@childrens.harvard.edu | |
| Contact: Elissa Weitzman, ScD 617-355-3538 elissa.weitzman@childrens.harvard.edu | |
| Principal Investigator: Sharon Levy, MD, MPH | |
| Principal Investigator: Elissa Weitzman, ScD, MSc | |
Sponsors and Collaborators
Children's Hospital Boston
Investigators
| Principal Investigator: | Sharon Levy, MD, MPH | Children's Hospital Boston |
| Principal Investigator: | Elissa Weitzman, ScD, MSc | Children's Hospital Boston |
More Information
No publications provided
| Responsible Party: | Children's Hospital Boston |
| ClinicalTrials.gov Identifier: | NCT01544218 History of Changes |
| Other Study ID Numbers: | SL_NIAAARFA_0212 |
| Study First Received: | February 15, 2012 |
| Last Updated: | January 2, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Hospital Boston:
|
Alcohol related disorders |
Additional relevant MeSH terms:
|
Alcohol-Related Disorders Substance-Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013