Alcohol UseNCT01797835
Alcohol Screening in an Ethnically Diverse Sample of Adolescents in Primary Care
A study testing CHAT brief MI intervention in people with Alcohol Use and Drug Use, run by RAND at 2 sites in United States.
Trial summary
Screening youth in the primary care setting is one way to identify adolescents who may be at-risk for future alcohol problems. The current study tests the new NIAAA screening guide questions, which ask about friend and adolescent drinking, to see how well these questions work to predict subsequent alcohol use… Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use, Drug Use
- What is being tested?
- CHAT brief MI intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 294 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2013to Aug 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 12-18
- speak English
Who cannot join
- cognitive impairment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Valley Community Clinic
North Hollywood, California, 91605
UPMC St. Margaret
Pittsburgh, Pennsylvania, 15215
About this study
Screening youth in the primary care setting is one way to identify adolescents who may be at-risk for future alcohol problems. The current study tests the new NIAAA screening guide questions, which ask about friend and adolescent drinking, to see how well these questions work to predict subsequent alcohol use, problems, and involvement in other risk behaviors, such as sexual risk-taking and delinquency. In addition, the investigators plan to provide a brief motivational intervention for some at-risk teens and see whether alcohol use differs for those teens who receive the intervention and those teens who receive enhanced usual care. The results of this study have the potential to significantly impact the standard of care for identifying and intervening with at- risk youth in primary care settings.
- Conditions
- Alcohol Use, Drug Use
- Being tested
- CHAT brief MI intervention, usual care
- Keywords
- adolescents, intervention, motivational interviewing, alcohol and drug use
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHAT brief MI interventionBehavioural
CHAT is one 15-20 minute session delivered in a single PC visit and utilizes motivational interviewing with youth to target alcohol and drug use in primary care.
usual careBehavioural
Youth receive a brochure with information on AOD use.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Placebo comparator | Youth in usual care will receive screening for alcohol and drug use. Those youth who are at risk will have a chance to talk to their provider about their use. They will also receive an informational brochure. Receives: Behavioral: usual care |
| CHAT brief MI intervention | Experimental | Youth in CHAT will receive screening for alcohol and drug use. Those youth who are at risk will have a chance to talk to their provider about their use. In addition, these youth will CHAT. CHAT is a brief motivational intervention that takes places in the primary care setting. It is a 15-20 minute intervention for adolescents age 12-18 focused on discussing alcohol and drug use. They will also receive a booster call one month later to check in on how they are doing. Receives: Behavioral: CHAT brief MI intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Times Used Alcohol
in the past three months: Number of times used alcohol; The 6-point frequency response scale (0= "Never" to 5= "More than 20 times") was rescaled to a pseudo-continuous variable ranging from 0 to 20 using the mid-point of any range as the new value (e.g. 3-10 times was recoded as 6.5 times).
Measured: Past 3 months
Secondary outcomes (1)
Number of Times Used Marijuana
number of times used marijuana in the past 3 months; The 6-point frequency response scale (0= "Never" to 5= "More than 20 times") was rescaled to a pseudo-continuous variable ranging from 0 to 20 using the mid-point of any range as the new value (e.g. 3-10 times was recoded as 6.5 times).
Measured: Past 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionNov 2015
- Study completionAug 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 (5)Papers the sponsor has linked to this study.
- Other trials for Alcohol UseStudies of the same condition, open and under way.
- 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
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- Valley Community Clinic, University of Pittsburgh
- Responsible party
- Sponsor
- Investigators
- Elizabeth J D'Amico, PhD, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797835
- Sponsor's protocol ID
- 1R01AA021786
- Status last verified
- Jul 2019
- First submitted
- 21 Feb 2013
- Last updated
- 17 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
D'Amico EJ, Parast L, Osilla KC, Seelam R, Meredith LS, Shadel WG, Stein BD. Understanding Which Teenagers Benefit Most From a Brief Primary Care Substance Use Intervention. Pediatrics. 2019 Aug;144(2):e20183014. doi: 10.1542/peds.2018-3014. Epub 2019 Jul 11.
PubMed 31296568Meredith LS, Seelam R, Stein BD, Parast L, Shadel WG, D'Amico EJ. Adolescents with better mental health have less problem alcohol use six months later. Addict Behav. 2019 Aug;95:77-81. doi: 10.1016/j.addbeh.2019.03.006. Epub 2019 Mar 7.
PubMed 30861475D'Amico EJ, Parast L, Shadel WG, Meredith LS, Seelam R, Stein BD. Brief motivational interviewing intervention to reduce alcohol and marijuana use for at-risk adolescents in primary care. J Consult Clin Psychol. 2018 Sep;86(9):775-786. doi: 10.1037/ccp0000332.
PubMed 30138016Meredith LS, Ewing BA, Stein BD, Shadel WG, Brooks Holliday S, Parast L, D'Amico EJ. Influence of mental health and alcohol or other drug use risk on adolescent reported care received in primary care settings. BMC Fam Pract. 2018 Jan 9;19(1):10. doi: 10.1186/s12875-017-0689-y.
PubMed 29316897D'Amico EJ, Parast L, Meredith LS, Ewing BA, Shadel WG, Stein BD. Screening in Primary Care: What Is the Best Way to Identify At-Risk Youth for Substance Use? Pediatrics. 2016 Dec;138(6):e20161717. doi: 10.1542/peds.2016-1717. Epub 2016 Nov 18.
PubMed 27940696
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Screening in an Ethnically Diverse Sample of Adolescents in Primary Care
- ClinicalTrials.gov ID
- NCT01797835
- Acronym / sponsor ID
- 1R01AA021786
- Conditions
- Alcohol Use, Drug Use
- Keywords
- adolescents, intervention, motivational interviewing, alcohol and drug use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- Valley Community Clinic, University of Pittsburgh
- Study start
- Mar 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 25 Feb 2013 (estimated)
- Results
- Posted 26 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Screening youth in the primary care setting is one way to identify adolescents who may be at-risk for future alcohol problems. The current study tests the new NIAAA screening guide questions, which ask about friend and adolescent drinking, to see how well these questions work to predict subsequent alcohol use, problems, and involvement in other risk behaviors, such as sexual risk-taking and delinquency. In addition, the investigators plan to provide a brief motivational intervention for some at-risk teens and see whether alcohol use differs for those teens who receive the intervention and those teens who receive enhanced usual care. The results of this study have the potential to significantly impact the standard of care for identifying and intervening with at- risk youth in primary care settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Placebo comparator | Behavioral: usual careYouth in usual care will receive screening for alcohol and drug use. Those youth who are at risk will have a chance to talk to their provider about their use. They will also receive an informational brochure. |
| CHAT brief MI intervention | Experimental | Behavioral: CHAT brief MI interventionYouth in CHAT will receive screening for alcohol and drug use. Those youth who are at risk will have a chance to talk to their provider about their use. In addition, these youth will CHAT. CHAT is a brief motivational intervention that takes places in the primary care setting. It is a 15-20 minute intervention for adolescents age 12-18 focused on discussing alcohol and drug use. They will also receive a booster call one month later to check in on how they are doing. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 12-18
- speak English
Key exclusion criteria (1 listed)
- cognitive impairment
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 |
|---|---|---|
| CHAT brief MI interventionCHAT is one 15-20 minute session delivered in a single PC visit and utilizes motivational interviewing with youth to target alcohol and drug use in primary care. | Behavioural | CHAT brief MI intervention |
| usual careYouth receive a brochure with information on AOD use. | Behavioural | Usual Care |
Primary outcome
Number of Times Used Alcohol
Time frame: Past 3 months
in the past three months: Number of times used alcohol; The 6-point frequency response scale (0= "Never" to 5= "More than 20 times") was rescaled to a pseudo-continuous variable ranging from 0 to 20 using the mid-point of any range as the new value (e.g. 3-10 times was recoded as 6.5 times).
1 secondary outcome
Number of Times Used Marijuana
Time frame: Past 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31296568D'Amico EJ, Parast L, Osilla KC, Seelam R, Meredith LS, Shadel WG, Stein BD. Understanding Which Teenagers Benefit Most From a Brief Primary Care Substance Use Intervention. Pediatrics. 2019 Aug;144(2):e20183014. doi: 10.1542/peds.2018-3014. Epub 2019 Jul 11.
- Derived from this study: PubMed 30861475Meredith LS, Seelam R, Stein BD, Parast L, Shadel WG, D'Amico EJ. Adolescents with better mental health have less problem alcohol use six months later. Addict Behav. 2019 Aug;95:77-81. doi: 10.1016/j.addbeh.2019.03.006. Epub 2019 Mar 7.
- Derived from this study: PubMed 30138016D'Amico EJ, Parast L, Shadel WG, Meredith LS, Seelam R, Stein BD. Brief motivational interviewing intervention to reduce alcohol and marijuana use for at-risk adolescents in primary care. J Consult Clin Psychol. 2018 Sep;86(9):775-786. doi: 10.1037/ccp0000332.
- Derived from this study: PubMed 29316897Meredith LS, Ewing BA, Stein BD, Shadel WG, Brooks Holliday S, Parast L, D'Amico EJ. Influence of mental health and alcohol or other drug use risk on adolescent reported care received in primary care settings. BMC Fam Pract. 2018 Jan 9;19(1):10. doi: 10.1186/s12875-017-0689-y.
- Derived from this study: PubMed 27940696D'Amico EJ, Parast L, Meredith LS, Ewing BA, Shadel WG, Stein BD. Screening in Primary Care: What Is the Best Way to Identify At-Risk Youth for Substance Use? Pediatrics. 2016 Dec;138(6):e20161717. doi: 10.1542/peds.2016-1717. Epub 2016 Nov 18.
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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.
Elizabeth J D'Amico, PhD principal investigator
RAND
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHAT brief MI intervention in people with Alcohol Use and Drug Use, run by RAND at 2 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 2 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 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. Some participants in this study may receive a placebo. 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 26 Jun 2019). 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?
Number of Times Used Alcohol (time frame: Past 3 months). 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 NCT01797835, which also lists 5 linked publications.
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 17 Jul 2019.