Interactive Motivational Media for Perinatal Drug Abuse - 3
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| Tracking Information | |||||
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| First Received Date ICMJE | September 29, 2005 | ||||
| Last Updated Date | October 29, 2012 | ||||
| Start Date ICMJE | September 2001 | ||||
| Primary Completion Date | February 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00230048 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 | Interactive Motivational Media for Perinatal Drug Abuse - 3 | ||||
| Official Title ICMJE | Interactive Motivational Media for Perinatal Drug Abuse | ||||
| Brief Summary | Interactive Motivational Media for Perinatal Drug Abuse |
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| Detailed Description | The goal of this exploratory/developmental proposal is to develop a low-cost, highly adaptable brief motivational intervention for perinatal drug abuse via embedding motivational principles in a self-contained interactive computer system. The Motivation Enhancement System (MES) will utilize a touch-screen, audio enhancement, and an interactive narrator to guide women in the immediate post-partum period through evaluation (thus facilitating self-report) and a one-time motivational intervention. A taxi voucher will be provided to further facilitate entry into treatment, and multiple tailored self-help mailings will be issued following discharge. If validated, this intervention could offer a highly cost-effective, replicable, and prescriptive method for increasing self-change and treatment involvement in drug abusers. Following development of the MES, a preliminary pilot phase will study the use of the MES with post-partum drug-using women and make necessary modifications, using data from participant debriefings and a single-case research design. After optimization of the MES, a clinical trial will randomly assign 120 post-partum drug-using women into treatment or assessment only conditions, with a 3-month blinded follow up to evaluate intervention effects on drug use and treatment involvement. Toxicological and self-report measures, as well as objective analysis of infant development, will be utilized. Participants will be lower socioeconomic status urban women. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Substance-Related Disorders | ||||
| Intervention ICMJE | Behavioral: Brief computer-delivered intervention
Brief (20-minute) computer delivered intervention, plus two subsequent non-tailored mailings. |
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| Study Arm (s) |
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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 | 107 | ||||
| Completion Date | February 2006 | ||||
| Primary Completion Date | February 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Woman in immediate postpartum period Inclusion Criteria: Screen positive for drug use (self-report) Exclusion Criteria: Frank psychosis or other cognitive impairment, fatigue, grief over medically compromised infant, inability to communicate in English |
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| Gender | Female | ||||
| Ages | 18 Years to 45 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00230048 | ||||
| Other Study ID Numbers ICMJE | NIDA-14621-3, R21DA014621 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Steven J. Ondersma, Wayne State University | ||||
| Study Sponsor ICMJE | Wayne State University | ||||
| Collaborators ICMJE | National Institute on Drug Abuse (NIDA) | ||||
| Investigators ICMJE |
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| Information Provided By | Wayne State University | ||||
| Verification Date | October 2012 | ||||
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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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