Medical Office Intervention for Adolescent Drug Use - Attention Study Supplement
| Tracking Information | |||||
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| First Received Date ICMJE | January 3, 2008 | ||||
| Last Updated Date | March 7, 2011 | ||||
| Start Date ICMJE | February 2007 | ||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Score on the Connors Continuous Performance Test II (CCPT II) [ Time Frame: Baseline ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00593034 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Percentage of days abstinent [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Medical Office Intervention for Adolescent Drug Use - Attention Study Supplement | ||||
| Official Title ICMJE | Medical Office Intervention for Adolescent Drug Use - Research Supplement for Under-represented Minorities | ||||
| Brief Summary | This study will use the CCPT II to assess attention in 12-21 year olds enrolled in a randomized controlled trial of a brief behavioral treatment for substance abuse. This study will describe at baseline levels of attention using a well validated instrument (Connors Continuous Performance Test II) and explore the association between attention levels and substance use. The primary study hypothesis is that lower initial levels of substance use (as measured by percent days abstinent) will be associated with higher attention levels. We envision that this data will inform a better understanding of how attention may modify treatment response. |
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| Detailed Description | Research among adolescents with substance use problems presents unique challenges to investigators. Issues with recruitment, confidentiality, and follow-up have been cited as common limitations to research in this area. One likely contributor to decreased treatment persistence and follow-up is the limited ability to sustain attention that many adolescents, especially those with substance problems, may manifest. (Taper, 2002) Thus, assessing attention before beginning substance abuse treatment has the potential not only to inform the science of adolescent addiction medicine, but also to guide the development of therapies to specifically address attention deficits among adolescent substance users. Adolescent outpatients being treated for substance problems have not been systematically studied for clinical or subclinical attention levels. The primary aims this study are as follows:
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Participants in this study will be 12-21 year old patients who have been referred to the Adolescent Substance Abuse Program for evaluation of drug or alcohol use and are participating in the parent study, "Medical Office Intervention for Adolescent Drug Abuse." |
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| Condition ICMJE | Substance-related Disorders | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | 1
Participants in this study will be 12-21 year old patients who have been referred to the Adolescent Substance Abuse Program for evaluation of drug or alcohol use and are participating in the parent study, "Medical Office Intervention for Adolescent Drug Abuse." |
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| Publications * |
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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 | Completed | ||||
| Enrollment ICMJE | 42 | ||||
| Completion Date | February 2008 | ||||
| Primary Completion Date | February 2008 (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 21 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00593034 | ||||
| Other Study ID Numbers ICMJE | R01 DA014553-03S1 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | John R. Knight, MD, Children's Hospital Boston | ||||
| Study Sponsor ICMJE | Children's Hospital Boston | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Children's Hospital Boston | ||||
| Verification Date | March 2011 | ||||
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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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