Alcohol DrinkingNCT01105416
Emergency Department (ED) Adolescent Alcohol Prevention Intervention
A study testing Brief Prevention Intervention (BPI) and ESC in people with Alcohol Drinking, run by Rhode Island Hospital at 1 site in United States.
Trial summary
The aim of the present study is to prevent or delay the initiation of alcohol use among young adolescents being seen in a pediatric emergency department, by enhancing parental monitoring and improving parent/adolescent conversations. Read more about this study
- Who is it for?
- Ages 12 to 14 years
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Brief Prevention Intervention (BPI) and ESC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jun 2012
- Phase
- Interventional
- 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 12 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Adolescents, age 12-14, who are being seen in the Pediatric ED for a non life-threatening injury and their parent/caregiver;
- Adolescent must be medically stable;
- For a parent/adolescent family unit to be eligible, one or both of the adolescent's parents must be present in the ED with the adolescent; and
- The adolescent must report not having initiated alcohol use.
Who cannot join
- Family units in which either the parent or the adolescent are cognitively unable to take part in the intervention;
- Those in which the youth is suspected by the clinical staff of being a victim of child abuse (these adolescents will be reported to child protective services);
- Those in which the youth is medically or surgically unstable;
- Family units in which the adolescent is being evaluated for a possible psychiatric disorder; and those without a telephone and/or a verifiable address of residence.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hasbro Children's Hospital Emergency Department
Providence, Rhode Island, 02903
About this study
Official title: Emergency Department Based Prevention Intervention to Delay Alcohol Use by Young Adolescents
The aim of the present study is to prevent or delay the initiation of alcohol use among young adolescents being seen in a pediatric emergency department, by enhancing parental monitoring and improving parent/adolescent conversations. Previous studies have shown that the pediatric emergency department is an excellent location for performing prevention interventions. By targeting individuals and their families in the pediatric emergency department (PED), we are capitalizing on the opportunity to perform a prevention intervention among a high risk population when parent and youth may be particularly receptive to the intervention.
Read the detailed description
Our long term goal is to develop, implement, and evaluate a program to prevent or delay the initiation of alcohol use in young adolescents by increasing protective factors and reducing risk through a family-based brief prevention intervention started in the pediatric emergency department (PED). The primary aims of the proposed developmental study include: (1) To pilot test a prevention intervention in alcohol-naïve adolescents, make necessary revisions, and finalize an intervention manual and (2) conduct a randomized pilot trial comparing the prevention intervention with enhanced standard care. After conducting an open trial of the prevention intervention with 10 adolescents, ages 12-14, and their accompanying parent(s), and refining the intervention, we will use a two-group randomized design to test the hypothesis that the prevention intervention will prevent/delay the initiation of alcohol use significantly more than enhanced standard care only. 100 adolescents, ages 12-14, who present to the PED and their accompanying parent(s)/caregiver will be enrolled into the study. Eligible, assenting adolescents and their consenting parent(s)/caregiver will complete a series of assessment instruments relating to alcohol and other drug (AOD) use, communication styles, parenting styles, and alcohol attitudes and behaviors. Parent/youth family units will then be randomly assigned to one of two conditions: 1) Enhanced Standard Care (ESC) or 2) Brief Targeted Prevention Intervention with Boosters (BTP). The initial session will be comprised of parent-targeted skill building directed primarily at parental monitoring and the importance of parent-adolescent communication as the precursor to successful monitoring. The primary goal of the prevention session will be the mobilization of the parents' own resources to increase communication and monitoring using motivational interviewing techniques. Parents within this condition will also receive periodic brochures and telephone booster sessions at 1 and 3 months to explore parental implementation of the plan from the previous session(s) and make revisions as necessary. Adolescents and parents will then be reassessed six months following their PED visit. Adolescents will also be assessed with monthly, brief, web-based follow-up contacts to determine the status of their alcohol use.
- Conditions
- Alcohol Drinking
- Being tested
- Brief Prevention Intervention (BPI), ESC
- Keywords
- Pediatric Emergency Department, Parental monitoring, Adolescent, Parents, Communication, Alcohol Drinking
- Medical subject headings
- Alcohol Drinking, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Prevention Intervention (BPI)Behavioural
Brief Prevention Intervention: Participants will receive the BPI, a brief, family-focused prevention intervention in the Pediatric ED. The session will be comprised of parent-targeted skill building directed primarily at parental monitoring and the importance of parent-adolescent communication as the precursor to successful monitoring.
ESCBehavioural
Enhanced standard care
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Standard Care (ESC) | Placebo comparator | Standard emergency department care plus informational brochures Receives: Behavioral: ESC |
| Brief Prevention Intervention (BPI) | Experimental | Brief Prevention Intervention in the Pediatric ED Receives: Behavioral: Brief Prevention Intervention (BPI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental monitoring
A one-tailed, α = 0.05 level of significance will be used to tests the difference between the BPI and ESC groups on hypotheses 2A on parental monitoring (using the PMQ and Parent/student self-check), 2B using the PMPI, drug use promoting peers, and parent/child beliefs and peers, 2C using scales on parent attitudes and parent beliefs about drug use, and 2D using intentions to use scale from the CTC.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startJul 2010
- Primary completionFeb 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, James Linakis Ph.D., Rhode Island Hospital
- Investigators
- James G Linakis, PhD, MD, Principal investigator, University Emergency Medicine Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105416
- Sponsor's protocol ID
- 0088-08
- Other IDs
- R21AA018380
- Status last verified
- Nov 2014
- First submitted
- 15 Apr 2010
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Department Based Prevention Intervention to Delay Alcohol Use by Young Adolescents
- ClinicalTrials.gov ID
- NCT01105416
- Acronym / sponsor ID
- 0088-08
- Conditions
- Alcohol Drinking
- Keywords
- Pediatric Emergency Department, Parental monitoring, Adolescent, Parents, Communication, Alcohol Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jul 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 16 Apr 2010 (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 aim of the present study is to prevent or delay the initiation of alcohol use among young adolescents being seen in a pediatric emergency department, by enhancing parental monitoring and improving parent/adolescent conversations. Previous studies have shown that the pediatric emergency department is an excellent location for performing prevention interventions. By targeting individuals and their families in the pediatric emergency department (PED), we are capitalizing on the opportunity to perform a prevention intervention among a high risk population when parent and youth may be particularly receptive to the intervention.
Detailed description
Our long term goal is to develop, implement, and evaluate a program to prevent or delay the initiation of alcohol use in young adolescents by increasing protective factors and reducing risk through a family-based brief prevention intervention started in the pediatric emergency department (PED). The primary aims of the proposed developmental study include: (1) To pilot test a prevention intervention in alcohol-naïve adolescents, make necessary revisions, and finalize an intervention manual and (2) conduct a randomized pilot trial comparing the prevention intervention with enhanced standard care. After conducting an open trial of the prevention intervention with 10 adolescents, ages 12-14, and their accompanying parent(s), and refining the intervention, we will use a two-group randomized design to test the hypothesis that the prevention intervention will prevent/delay the initiation of alcohol use significantly more than enhanced standard care only. 100 adolescents, ages 12-14, who present to the PED and their accompanying parent(s)/caregiver will be enrolled into the study. Eligible, assenting adolescents and their consenting parent(s)/caregiver will complete a series of assessment instruments relating to alcohol and other drug (AOD) use, communication styles, parenting styles, and alcohol attitudes and behaviors. Parent/youth family units will then be randomly assigned to one of two conditions: 1) Enhanced Standard Care (ESC) or 2) Brief Targeted Prevention Intervention with Boosters (BTP). The initial session will be comprised of parent-targeted skill building directed primarily at parental monitoring and the importance of parent-adolescent communication as the precursor to successful monitoring. The primary goal of the prevention session will be the mobilization of the parents' own resources to increase communication and monitoring using motivational interviewing techniques. Parents within this condition will also receive periodic brochures and telephone booster sessions at 1 and 3 months to explore parental implementation of the plan from the previous session(s) and make revisions as necessary. Adolescents and parents will then be reassessed six months following their PED visit. Adolescents will also be assessed with monthly, brief, web-based follow-up contacts to determine the status of their alcohol use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Standard Care (ESC) | Placebo comparator | Behavioral: ESCStandard emergency department care plus informational brochures |
| Brief Prevention Intervention (BPI) | Experimental | Behavioral: Brief Prevention Intervention (BPI)Brief Prevention Intervention in the Pediatric ED |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Adolescents, age 12-14, who are being seen in the Pediatric ED for a non life-threatening injury and their parent/caregiver;
- Adolescent must be medically stable;
- For a parent/adolescent family unit to be eligible, one or both of the adolescent's parents must be present in the ED with the adolescent; and
- The adolescent must report not having initiated alcohol use.
Key exclusion criteria (4 listed)
- Family units in which either the parent or the adolescent are cognitively unable to take part in the intervention;
- Those in which the youth is suspected by the clinical staff of being a victim of child abuse (these adolescents will be reported to child protective services);
- Those in which the youth is medically or surgically unstable;
- Family units in which the adolescent is being evaluated for a possible psychiatric disorder; and those without a telephone and/or a verifiable address of residence.
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 |
|---|---|---|
| Brief Prevention Intervention (BPI)Brief Prevention Intervention: Participants will receive the BPI, a brief, family-focused prevention intervention in the Pediatric ED. The session will be comprised of parent-targeted skill building directed primarily at parental monitoring and the importance of parent-adolescent communication as the precursor to successful monitoring. | Behavioural | Brief Prevention Intervention (BPI) |
| ESCEnhanced standard care | Behavioural | Enhanced Standard Care (ESC) |
Primary outcome
Parental monitoring
Time frame: 2 years
A one-tailed, α = 0.05 level of significance will be used to tests the difference between the BPI and ESC groups on hypotheses 2A on parental monitoring (using the PMQ and Parent/student self-check), 2B using the PMPI, drug use promoting peers, and parent/child beliefs and peers, 2C using scales on parent attitudes and parent beliefs about drug use, and 2D using intentions to use scale from the CTC.
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 5 Nov 2014.
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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.
James G Linakis, PhD, MD principal investigator
University Emergency Medicine Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Prevention Intervention (BPI) and ESC in people with Alcohol Drinking, run by Rhode Island 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: finished, as of the sponsor's last update on 5 Nov 2014. 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. 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?
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?
Parental monitoring (time frame: 2 years). 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 5 Nov 2014.