Alcohol Related DisorderscASCANCT01539954
Computerized Alcohol Screening for Children and Adolescents
An observational study of Alcohol Related Disorders, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The goal of this project is to develop a computerized screening program for primary care offices that is based on the NIAAA's Alcohol Screening Guide for Children and Adolescents and assess its psychometric properties among nine- to 18-yr-old primary care patients. 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Sep 2015
- 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: Youth 9-18 years old
Who may be able to join
- nine- to 18-years old
- arriving for non-emergent care
- have an email address and internet access
- provide informed assent/consent.
Who cannot join
- unable to read or understand English
- living away at college at the time of the recruitment visit
- not available for computer/telephone follow-ups
- judged by the provider to be medically or emotionally unstable at time of visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: Computerized Alcohol Screening for Children and Adolescents (cASCA) in Primary Care
The goal of this project is to develop a computerized screening program for primary care offices that is based on the NIAAA's Alcohol Screening Guide for Children and Adolescents and assess its psychometric properties among nine- to 18-yr-old primary care patients. There have been few studies of alcohol screening and brief intervention conducted among adolescents receiving primary medical care. This project will develop and validate a new computerized Alcohol Screening for Children and Adolescents (cASCA) system based on the two age-specific screening questions of the NIAAA Guide and includes the CRAFFT and AUDIT as secondary risk and problem assessments. The system will yield a provider report with the screening results, level of risk, and recommended brief advice, counseling, or referral strategies. The Specific Aims of this project are to: 1)Assess the sensitivity, specificity, positive and negative predictive values of the 'any drinking/number of drinking days' and 'friends' questions of the cASCA in identifying past-year use as determined by the Timeline Follow-Back Calendar (TLFB), and for identifying any problem use, abuse or dependence as determined by the AUDIT, CRAFFT and a structured psychiatric diagnostic interview (computerized DISC-IV, Youth Version) at baseline (criterion validity); 2)Assess the test-retest reliability of the cASCA in measuring drinking frequency categories and in classifying patients into Low, Medium and High risk categories; 3)Assess the predictive validity of the 'any drinking/number of drinking days' and 'friends' questions in predicting drinking, "binge" drinking, and any problem use, abuse or dependence at 12-mos follow-up; 4)Assess the degree to which the 'any drinking/number of drinking days' item of the cASCA predicts drug use risk as measured by the TLFB (any use and frequency), tobacco use as measured by the Hooked on Nicotine Checklist (screen for potential nicotine dependence), drug use disorders as measured by the Drug Abuse Screening Test for Adolescents, and the degree to which it predicts other mental health problems as measured by the Youth DISC Predictive Scales at baseline and 12-month follow-up; 5)Compare the psychometric properties of the cASCA across subgroups, including: age, gender, race/ethnicity, practice type, provider type, and patient risks (e.g., those with/without friends who drink); and explore the possible effects of the cASCA system on drinking at 3-, 6-, 9-, and 12-month follow-ups.
- 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 |
|---|---|---|
| Youth 9-18 years of age | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity and sensitivity of cASCA
We will examine validity of the lifetime "any drinking" item by comparing participant responses on the c-ASCA to responses on the Brief Substance Use History (BSUH) questionnaire (lifetime use and age of initiation of use, if any).
Measured: Baseline
Secondary outcomes (2)
Test-retest reliability of cASCA
We will calculate Cohen's kappas to evaluate 1-2 week test-retest agreement on c-ASCA responses
Measured: baseline
Validity of "number of drinking days" item in c-ASCA
For middle and high school-aged youth (12-18 yrs), we will examine validity of the c-ASCA past-year "number of drinking days" by computing the intra-class correlation coefficients (ICC) assessing agreement between the two continuous variables of total past-year number of days reported on c-ASCA and on the TLFB.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Why it stopped: The project was not funded.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John R Knight, MD, Boston Children's Hospital
- Investigators
- John R Knight, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539954
- Sponsor's protocol ID
- JK_NIAAA_02-12
- Acronym
- cASCA
- Status last verified
- Oct 2016
- First submitted
- 16 Feb 2012
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Alcohol Screening for Children and Adolescents (cASCA) in Primary Care
- ClinicalTrials.gov ID
- NCT01539954
- Acronym / sponsor ID
- cASCA / JK_NIAAA_02-12
- Conditions
- Alcohol Related Disorders
- Keywords
- Alcohol related disorders
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The project was not funded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 28 Feb 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.
The goal of this project is to develop a computerized screening program for primary care offices that is based on the NIAAA's Alcohol Screening Guide for Children and Adolescents and assess its psychometric properties among nine- to 18-yr-old primary care patients. There have been few studies of alcohol screening and brief intervention conducted among adolescents receiving primary medical care. This project will develop and validate a new computerized Alcohol Screening for Children and Adolescents (cASCA) system based on the two age-specific screening questions of the NIAAA Guide and includes the CRAFFT and AUDIT as secondary risk and problem assessments. The system will yield a provider report with the screening results, level of risk, and recommended brief advice, counseling, or referral strategies. The Specific Aims of this project are to: 1)Assess the sensitivity, specificity, positive and negative predictive values of the 'any drinking/number of drinking days' and 'friends' questions of the cASCA in identifying past-year use as determined by the Timeline Follow-Back Calendar (TLFB), and for identifying any problem use, abuse or dependence as determined by the AUDIT, CRAFFT and a structured psychiatric diagnostic interview (computerized DISC-IV, Youth Version) at baseline (criterion validity); 2)Assess the test-retest reliability of the cASCA in measuring drinking frequency categories and in classifying patients into Low, Medium and High risk categories; 3)Assess the predictive validity of the 'any drinking/number of drinking days' and 'friends' questions in predicting drinking, "binge" drinking, and any problem use, abuse or dependence at 12-mos follow-up; 4)Assess the degree to which the 'any drinking/number of drinking days' item of the cASCA predicts drug use risk as measured by the TLFB (any use and frequency), tobacco use as measured by the Hooked on Nicotine Checklist (screen for potential nicotine dependence), drug use disorders as measured by the Drug Abuse Screening Test for Adolescents, and the degree to which it predicts other mental health problems as measured by the Youth DISC Predictive Scales at baseline and 12-month follow-up; 5)Compare the psychometric properties of the cASCA across subgroups, including: age, gender, race/ethnicity, practice type, provider type, and patient risks (e.g., those with/without friends who drink); and explore the possible effects of the cASCA system on drinking at 3-, 6-, 9-, and 12-month follow-ups.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Youth 9-18 years of age | – | – |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Youth 9-18 years old
Key inclusion criteria (4 listed)
- nine- to 18-years old
- arriving for non-emergent care
- have an email address and internet access
- provide informed assent/consent.
Key exclusion criteria (4 listed)
- unable to read or understand English
- living away at college at the time of the recruitment visit
- not available for computer/telephone follow-ups
- judged by the provider to be medically or emotionally unstable at time of visit.
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
Specificity and sensitivity of cASCA
Time frame: Baseline
We will examine validity of the lifetime "any drinking" item by comparing participant responses on the c-ASCA to responses on the Brief Substance Use History (BSUH) questionnaire (lifetime use and age of initiation of use, if any).
2 secondary outcomes
Test-retest reliability of cASCA
Time frame: baseline
Validity of "number of drinking days" item in c-ASCA
Time frame: Baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
- Center for Adolescent Substance Abuse ResearchLink provided by the sponsor.
- 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.
John R Knight, MD 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 4 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: withdrawn, as of the sponsor's last update on 7 Oct 2016. 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 was withdrawn before enrolling participants, so there are no results.
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?
Specificity and sensitivity of cASCA (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 7 Oct 2016.