Alcohol AbusePhase 1NCT00247221
Brief Intervention for Families of Teens Treated in the Emergency Department for an Alcohol-Related Event
A Phase 1 study testing MI/Family Check-up and MI only in people with Alcohol Abuse, run by Brown University at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness of a brief family intervention in reducing alcohol use and alcohol-related problems among families of underage drinkers (13-17 years old) who are treated in a hospital emergency department for an alcohol-related event. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Abuse
- What is being tested?
- MI/Family Check-up and MI only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Jul 2008
- Phase
- Phase 1
- 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child aged 13-17 years
- Receiving treatment at the approved medical Emergency Department
- Child living in a home with at least one parent or legal guardian
Who cannot join
- Children who are suicidal, in police custody, not alert/oriented, non-English speaking, in severe pain, or who have sustained severe trauma
- Children with a history of prior substance abuse treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital/Lifespan Corporation and Brown University
Providence, Rhode Island, 02903
About this study
Official title: Family Motivational Interviews for ETOH+ Teens in the ER
The purpose of this study is to compare the effectiveness of a brief family intervention in reducing alcohol use and alcohol-related problems among families of underage drinkers (13-17 years old) who are treated in a hospital emergency department for an alcohol-related event.
Read the detailed description
The long-term objectives of this research program are to develop effective interventions in health care settings for reducing problem drinking and associated problems among adolescents and to further enhance intervention approaches by identifying effective elements of treatment. The major purpose of this study is to compare a brief integrated individual and family intervention designed to reduce alcohol use and related problems to an enhanced standard care condition (standard care plus family assessment).
The targeted population is underage drinkers (13-17 years old) who have been treated in an Emergency Department following an alcohol-related event. It is important to intervene with this population because alcohol-involved adolescents may be at higher risk for having continuing alcohol problems (Fillmore, 1988; Zucker, in press). The intervention is conceptualized as using a "teachable moment" (i.e., shortly after a salient event) to increase family interest in reducing harmful drinking. The experimental intervention integrates an individual Motivational Interview (MI) for the adolescent, based on our research group's prior work with this intervention, with a brief family intervention, the Family Check-Up (Dishion \& Kavanagh, 2003).
The experimental condition will be compared to standard care plus family assessment. This design allows us to test the added benefit of the brief family intervention compared to the benefits often derived from assessment without added treatment. Follow-up interviews will be conducted at 3, 6, and 12 months after the baseline intervention to assess outcome. The specific aims of this proposal are to test the effectiveness of the experimental intervention in reducing alcohol-related problems, alcohol consumption, and other behavior problems compared to the enhanced standard care condition. Second, we will examine whether depressed mood and behavior problems at baseline moderate the effects of the treatment conditions. We will also test whether individual factors (motivation to change behavior) and environmental factors (parent/family influence and peer influence) mediate the relation between the treatment condition and outcomes.
- Conditions
- Alcohol Abuse
- Being tested
- MI/Family Check-up, MI only
- Keywords
- Alcohol, Substance abuse, Adolescent, Family functioning
- Medical subject headings
- Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MI/Family Check-upBehavioural
The experimental intervention integrates an individual Motivational Interview (MI) for the adolescent with a brief family intervention, the Family Check-Up. Follow-up interviews will be conducted at 3, 6, and 12 months after the baseline intervention.
MI onlyBehavioural
An individual motivational interview (IMI only) will be conducted at 3, 6, and 12 months after the baseline intervention to assess outcome.
| Study group | Role | What they receive |
|---|---|---|
| 1) MI/Family Check-Up | Experimental | Brief integrated individual and family intervention -- the experimental intervention integrates an individual Motivational Interview (MI) for the adolescent with a brief family intervention, the Family Check-Up Receives: Behavioral: MI/Family Check-up |
| 2) MI only | Active comparator | Not described Receives: Behavioral: MI only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol use
Drinking frequency (days per month), quantity (drinks per occasion), and frequency of high-volume drinking (5 or more drinks per occasion) over the prior 3 months.
Measured: 3 months
Alcohol use
Drinking frequency (days per month), quantity (drinks per occasion), and frequency of high-volume drinking (5 or more drinks per occasion) over the prior 3 months.
Measured: 6 months
Alcohol use
Drinking frequency (days per month), quantity (drinks per occasion), and frequency of high-volume drinking (5 or more drinks per occasion) over the prior 3 months.
Measured: 12 months
Secondary outcomes (3)
marijuana use
Days of use in prior 3 months
Measured: 3 months
Marijuana use
Days of use in prior 3 months
Measured: 6 months
Marijuana use
Days of use in prior 3 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2005 (estimated)
- Study startOct 2002
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Anthony Spirito, Brown University
- Investigators
- Anthony Spirito, PhD, Study director, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247221
- Sponsor's protocol ID
- NIAAASPI013385
- Other IDs
- R01AA013385, NIH grant R01 AA013385
- Status last verified
- Jul 2012
- First submitted
- 28 Oct 2005
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Spirito A, Sindelar-Manning H, Colby SM, Barnett NP, Lewander W, Rohsenow DJ, Monti PM. Individual and family motivational interventions for alcohol-positive adolescents treated in an emergency department: results of a randomized clinical trial. Arch Pediatr Adolesc Med. 2011 Mar;165(3):269-74. doi: 10.1001/archpediatrics.2010.296.
PubMed 21383276
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Motivational Interviews for ETOH+ Teens in the ER
- ClinicalTrials.gov ID
- NCT00247221
- Acronym / sponsor ID
- NIAAASPI013385
- Conditions
- Alcohol Abuse
- Keywords
- Alcohol, Substance abuse, Adolescent, Family functioning
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Oct 2002
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 1 Nov 2005 (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 purpose of this study is to compare the effectiveness of a brief family intervention in reducing alcohol use and alcohol-related problems among families of underage drinkers (13-17 years old) who are treated in a hospital emergency department for an alcohol-related event.
Detailed description
The long-term objectives of this research program are to develop effective interventions in health care settings for reducing problem drinking and associated problems among adolescents and to further enhance intervention approaches by identifying effective elements of treatment. The major purpose of this study is to compare a brief integrated individual and family intervention designed to reduce alcohol use and related problems to an enhanced standard care condition (standard care plus family assessment).
The targeted population is underage drinkers (13-17 years old) who have been treated in an Emergency Department following an alcohol-related event. It is important to intervene with this population because alcohol-involved adolescents may be at higher risk for having continuing alcohol problems (Fillmore, 1988; Zucker, in press). The intervention is conceptualized as using a "teachable moment" (i.e., shortly after a salient event) to increase family interest in reducing harmful drinking. The experimental intervention integrates an individual Motivational Interview (MI) for the adolescent, based on our research group's prior work with this intervention, with a brief family intervention, the Family Check-Up (Dishion \& Kavanagh, 2003).
The experimental condition will be compared to standard care plus family assessment. This design allows us to test the added benefit of the brief family intervention compared to the benefits often derived from assessment without added treatment. Follow-up interviews will be conducted at 3, 6, and 12 months after the baseline intervention to assess outcome. The specific aims of this proposal are to test the effectiveness of the experimental intervention in reducing alcohol-related problems, alcohol consumption, and other behavior problems compared to the enhanced standard care condition. Second, we will examine whether depressed mood and behavior problems at baseline moderate the effects of the treatment conditions. We will also test whether individual factors (motivation to change behavior) and environmental factors (parent/family influence and peer influence) mediate the relation between the treatment condition and outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1) MI/Family Check-Up | Experimental | Behavioral: MI/Family Check-upBrief integrated individual and family intervention -- the experimental intervention integrates an individual Motivational Interview (MI) for the adolescent with a brief family intervention, the Family Check-Up |
| 2) MI only | Active comparator | Behavioral: MI only |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child aged 13-17 years
- Receiving treatment at the approved medical Emergency Department
- Child living in a home with at least one parent or legal guardian
Key exclusion criteria (2 listed)
- Children who are suicidal, in police custody, not alert/oriented, non-English speaking, in severe pain, or who have sustained severe trauma
- Children with a history of prior substance abuse treatment
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 |
|---|---|---|
| MI/Family Check-upThe experimental intervention integrates an individual Motivational Interview (MI) for the adolescent with a brief family intervention, the Family Check-Up. Follow-up interviews will be conducted at 3, 6, and 12 months after the baseline intervention. | Behavioural | 1) MI/Family Check-Up |
| MI onlyAn individual motivational interview (IMI only) will be conducted at 3, 6, and 12 months after the baseline intervention to assess outcome. | Behavioural | 2) MI only |
Primary outcome
Alcohol use
Time frame: 3 months
Drinking frequency (days per month), quantity (drinks per occasion), and frequency of high-volume drinking (5 or more drinks per occasion) over the prior 3 months.
Alcohol use
Time frame: 6 months
Drinking frequency (days per month), quantity (drinks per occasion), and frequency of high-volume drinking (5 or more drinks per occasion) over the prior 3 months.
Alcohol use
Time frame: 12 months
Drinking frequency (days per month), quantity (drinks per occasion), and frequency of high-volume drinking (5 or more drinks per occasion) over the prior 3 months.
3 secondary outcomes
marijuana use
Time frame: 3 months
Marijuana use
Time frame: 6 months
Marijuana use
Time frame: 12 months
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 31 Jul 2012.
- Derived from this study: PubMed 21383276Spirito A, Sindelar-Manning H, Colby SM, Barnett NP, Lewander W, Rohsenow DJ, Monti PM. Individual and family motivational interventions for alcohol-positive adolescents treated in an emergency department: results of a randomized clinical trial. Arch Pediatr Adolesc Med. 2011 Mar;165(3):269-74. doi: 10.1001/archpediatrics.2010.296.
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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.
Anthony Spirito, PhD study director
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MI/Family Check-up and MI only in people with Alcohol Abuse, run by Brown University 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 31 Jul 2012. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Alcohol use (time frame: 3 months). The study lists 3 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 NCT00247221, 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 31 Jul 2012.