Emergency Department (ED) Adolescent Alcohol Prevention Intervention
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | April 15, 2010 | ||||
| Last Updated Date | August 3, 2010 | ||||
| Start Date ICMJE | July 2010 | ||||
| Estimated Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Parental monitoring [ Time Frame: 2 years ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01105416 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Emergency Department (ED) Adolescent Alcohol Prevention Intervention | ||||
| Official Title ICMJE | Emergency Department Based Prevention Intervention to Delay Alcohol Use by Young Adolescents | ||||
| Brief 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. 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Alcohol Drinking | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 220 | ||||
| Estimated Completion Date | March 2012 | ||||
| Estimated Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 12 Years to 14 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01105416 | ||||
| Other Study ID Numbers ICMJE | 0088-08, R21AA018380 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | James G. Linakis, Rhode Island Hospital | ||||
| Study Sponsor ICMJE | Rhode Island Hospital | ||||
| Collaborators ICMJE | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | ||||
| Investigators ICMJE |
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| Information Provided By | Rhode Island Hospital | ||||
| Verification Date | April 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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