Prevention Harmful EffectscASCANCT02233946
Computerized Alcohol Screening for Children and Adolescents (cASCA) in Primary Care
A study testing computer-facilitated brief intervention in people with Prevention Harmful Effects, run by Boston Children's Hospital at 5 sites in United States.
Trial summary
The purpose of this study is to assess the psychometric properties of a brief screening questionnaire for alcohol problems among 9- to 18-year-old patients in pediatricians' offices, and to pilot test a personalized, computer-facilitated brief intervention delivered on a tablet computer and by the provider based on… Read more about this study
- Who is it for?
- Ages 9 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention Harmful Effects
- What is being tested?
- computer-facilitated brief intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 871 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2015to 31 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- access to computer and email address
- available and willing to complete all follow ups by email or phone
- medically and emotionally stable
- can read and understand English
Who cannot join
- Patient has already participated in this study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Tufts Medical Center
Boston, Massachusetts, 02111
Boston Childrens Primary Care Center
Boston, Massachusetts, 02115
Longwood Pediatrics
Boston, Massachusetts, 02115
East Boston Neighborhood Health Center
East Boston, Massachusetts, 02128
Lexington Pediatrics
Lexington, Massachusetts, 02421
About this study
The purpose of this study is to assess the psychometric properties of a brief screening questionnaire for alcohol problems among 9- to 18-year-old patients in pediatricians' offices, and to pilot test a personalized, computer-facilitated brief intervention delivered on a tablet computer and by the provider based on screening results.
Read the detailed description
The primary goal of this project is to develop a computerized screening program for primary care offices that is based on the NIAAA's new Alcohol Screening Guide for Children and Adolescents and assess its psychometric properties among nine- to 18-yr-old primary care patients. There is substantial evidence supporting the effectiveness of screening and brief intervention among adult primary care patients, primarily in the reduction of harmful drinking. However, there have been few studies of alcohol screening and brief intervention conducted among adolescents seen in busy primary care settings. This project will develop and validate a new computerized Alcohol Screening for Children and Adolescents (cASCA) program which incorporates the age-specific screening questions of the NIAAA Guide and includes the CRAFFT and AUDIT as secondary risk/problem assessments. We will add tobacco screening because tobacco use is the leading cause of cancer-related mortality in the US as well as screening for marijuana and other drug use so as to create a comprehensive screening instrument that includes all major substances that adolescents use.
Additionally, the NIAAA guide recommends that providers deliver a brief intervention in response to the screening results. Therefore, a secondary aim of this project will be to pilot-test a computer-facilitated Brief Intervention component using a randomized design comparing three groups: 1) screening with treatment as usual [cASCA/TAU]; 2) screening with the computer-facilitated brief intervention [cASCA/BI]. The BI component consists of patients viewing on the computer, immediately after the screening, their score and level of risk for a substance use problem, as well as several interactive pages of science and true-life stories about the health risks of substance use. Clinicians are then given the screen results and suggested talking points for a few minutes of brief counseling during the visit.
Hypothesis: Among 9- to 18-year-old primary care patients, those receiving cASCA/BI will have lower rates of any alcohol use, days of alcohol use, drinks per drinking day, and days of heavy episodic drinking, at 3, 6, 9 and 12-months follow-up than those receiving treatment as usual.
- Conditions
- Prevention Harmful Effects
- Being tested
- computer-facilitated brief intervention
- Keywords
- Substance Abuse, Prevention, Youth, Alcohol, Drugs
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer-facilitated brief interventionBehavioural
Immediate feedback to patient of screening results and risk for substance use problem, followed by 11 pages of science and true-life stories about health risks of adolescent substance use. Screening results then go to provider who reviews them with patient and gives brief counseling, and refers to an online motivational enhancement therapy intervention for patients at moderate/high risk for substance use problems.
| Study group | Role | What they receive |
|---|---|---|
| screening w/ computer brief intervention | Experimental | screening with computer-facilitated brief intervention Receives: Behavioral: computer-facilitated brief intervention |
| Screening with Treatment as Usual | No intervention | Screening with Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Post-visit Drinking Day
Median (and interquartile range) for times to first use for the cSBI and Treatment As Usual (TAU) groups
Measured: 12-months follow-up
Time to First Post-visit Heavy Episodic Drinking Day
The number of days post-visit to first reported heavy episodic drinking day
Measured: 12-months follow-up
Secondary outcomes (2)
Time to First Post-visit Cannabis Use Day
The number of days post-visit to first reported cannabis use day.
Measured: 12-months follow-up
Past-3-month Riding Risk
Self-reported riding in the past 3 months with a driver who had been drinking or using other drugs, stratified by reported riding risk in the past 3 months at baseline
Measured: 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startJan 2015
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prevention Harmful EffectsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 871 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Sion Kim Harris, Boston Children's Hospital
- Investigators
- John R Knight, MD, Principal investigator, Boston Children's HospitalSion K Harris, PhD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233946
- Sponsor's protocol ID
- P00004862
- Other IDs
- 1R01AA021904-01
- Acronym
- cASCA
- Status last verified
- Feb 2021
- First submitted
- 19 Aug 2014
- Last updated
- 11 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Harris SK, Csemy L, Sherritt L, Starostova O, Van Hook S, Johnson J, Boulter S, Brooks T, Carey P, Kossack R, Kulig JW, Van Vranken N, Knight JR. Computer-facilitated substance use screening and brief advice for teens in primary care: an international trial. Pediatrics. 2012 Jun;129(6):1072-82. doi: 10.1542/peds.2011-1624. Epub 2012 May 7.
PubMed 22566420
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. 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
- NCT02233946
- Acronym / sponsor ID
- cASCA / P00004862
- Conditions
- Prevention Harmful Effects
- Keywords
- Substance Abuse, Prevention, Youth, Alcohol, Drugs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 871 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jan 2015
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Posted 11 Mar 2021
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 assess the psychometric properties of a brief screening questionnaire for alcohol problems among 9- to 18-year-old patients in pediatricians' offices, and to pilot test a personalized, computer-facilitated brief intervention delivered on a tablet computer and by the provider based on screening results.
Detailed description
The primary goal of this project is to develop a computerized screening program for primary care offices that is based on the NIAAA's new Alcohol Screening Guide for Children and Adolescents and assess its psychometric properties among nine- to 18-yr-old primary care patients. There is substantial evidence supporting the effectiveness of screening and brief intervention among adult primary care patients, primarily in the reduction of harmful drinking. However, there have been few studies of alcohol screening and brief intervention conducted among adolescents seen in busy primary care settings. This project will develop and validate a new computerized Alcohol Screening for Children and Adolescents (cASCA) program which incorporates the age-specific screening questions of the NIAAA Guide and includes the CRAFFT and AUDIT as secondary risk/problem assessments. We will add tobacco screening because tobacco use is the leading cause of cancer-related mortality in the US as well as screening for marijuana and other drug use so as to create a comprehensive screening instrument that includes all major substances that adolescents use.
Additionally, the NIAAA guide recommends that providers deliver a brief intervention in response to the screening results. Therefore, a secondary aim of this project will be to pilot-test a computer-facilitated Brief Intervention component using a randomized design comparing three groups: 1) screening with treatment as usual [cASCA/TAU]; 2) screening with the computer-facilitated brief intervention [cASCA/BI]. The BI component consists of patients viewing on the computer, immediately after the screening, their score and level of risk for a substance use problem, as well as several interactive pages of science and true-life stories about the health risks of substance use. Clinicians are then given the screen results and suggested talking points for a few minutes of brief counseling during the visit.
Hypothesis: Among 9- to 18-year-old primary care patients, those receiving cASCA/BI will have lower rates of any alcohol use, days of alcohol use, drinks per drinking day, and days of heavy episodic drinking, at 3, 6, 9 and 12-months follow-up than those receiving treatment as usual.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| screening w/ computer brief intervention | Experimental | Behavioral: computer-facilitated brief interventionscreening with computer-facilitated brief intervention |
| Screening with Treatment as Usual | No intervention | –Screening with Treatment as Usual |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- access to computer and email address
- available and willing to complete all follow ups by email or phone
- medically and emotionally stable
- can read and understand English
Key exclusion criteria (1 listed)
- Patient has already participated in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computer-facilitated brief interventionImmediate feedback to patient of screening results and risk for substance use problem, followed by 11 pages of science and true-life stories about health risks of adolescent substance use. Screening results then go to provider who reviews them with patient and gives brief counseling, and refers to an online motivational enhancement therapy intervention for patients at moderate/high risk for substance use problems. | Behavioural | screening w/ computer brief intervention |
Primary outcome
Time to First Post-visit Drinking Day
Time frame: 12-months follow-up
Median (and interquartile range) for times to first use for the cSBI and Treatment As Usual (TAU) groups
Time to First Post-visit Heavy Episodic Drinking Day
Time frame: 12-months follow-up
The number of days post-visit to first reported heavy episodic drinking day
2 secondary outcomes
Time to First Post-visit Cannabis Use Day
Time frame: 12-months follow-up
Past-3-month Riding Risk
Time frame: 12 months follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22566420Harris SK, Csemy L, Sherritt L, Starostova O, Van Hook S, Johnson J, Boulter S, Brooks T, Carey P, Kossack R, Kulig JW, Van Vranken N, Knight JR. Computer-facilitated substance use screening and brief advice for teens in primary care: an international trial. Pediatrics. 2012 Jun;129(6):1072-82. doi: 10.1542/peds.2011-1624. Epub 2012 May 7.
- Center for Adolescent Substance Abuse ResearchLink provided by the sponsor.
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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
Sion K Harris, PhD principal investigator
Boston Children's Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computer-facilitated brief intervention in people with Prevention Harmful Effects, run by Boston Children's Hospital at 5 sites 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 1 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 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Yes. Results are posted in the registry (first posted 11 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to First Post-visit Drinking Day (time frame: 12-months follow-up). 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?
On the ClinicalTrials.gov record for NCT02233946, which also lists 1 linked publication.
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 11 Mar 2021.