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| ID | Type | Description | Link |
|---|---|---|---|
| R21DA014621 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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Interactive Motivational Media for Perinatal Drug Abuse
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assessment only | No Intervention | ||
| Brief intervention | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief computer-delivered intervention | Behavioral | Brief (20-minute) computer delivered intervention, plus two subsequent non-tailored mailings. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Drug Use at 3 Months | The number of participants postive for drug use using participant's self-report of drug use and urinalysis. Participants were considered positive if self-report and/or urinalysis were positive. | 3 months |
| Treatment Engagement | Completing at least a single intake or treatment session of any kind, focused on substance use within the previous 3 months. | 3 months |
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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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| Name | Affiliation | Role |
|---|---|---|
| Steven J Ondersma, Ph.D. | ACT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wayne State University | Detroit | Michigan | 48207 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15925264 | Result | Ondersma SJ, Chase SK, Svikis DS, Schuster CR. Computer-based brief motivational intervention for perinatal drug use. J Subst Abuse Treat. 2005 Jun;28(4):305-12. doi: 10.1016/j.jsat.2005.02.004. | |
| 17236741 | Result | Ondersma SJ, Svikis DS, Schuster CR. Computer-based brief intervention a randomized trial with postpartum women. Am J Prev Med. 2007 Mar;32(3):231-8. doi: 10.1016/j.amepre.2006.11.003. Epub 2007 Jan 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Assessment Only | This arm answered questions only, but received no intervention. |
| FG001 | Brief Intervention | Brief computer-delivered intervention following motivational approach, adapted from Motivational Interviewing: Decisional balance, normed feedback, and optional goal-setting. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Assessment Only | This arm answered questions only, but received no intervention. |
| BG001 | Brief Intervention | Brief computer-delivered intervention following 5As/5Rs approach. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Drug Use at 3 Months | The number of participants postive for drug use using participant's self-report of drug use and urinalysis. Participants were considered positive if self-report and/or urinalysis were positive. | Intent to treat, treating participants lost to follow-up as positive. | Posted | Number | participants | 3 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Assessment Only | This arm answered questions only, but received no intervention. |
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Generalizability limited by relatively small sample, attrition of 29%, and restriction to low-income mothers. Second, power limitations prevented verification of effects on the dichotomous outcomes, despite effects in the small-moderate range.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven J. Ondersma | Wayne State University | 313-577-6680 | s.ondersma@wayne.edu |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Treatment Engagement | Completing at least a single intake or treatment session of any kind, focused on substance use within the previous 3 months. | ITT, treating all participants lost to follow up as failures (i.e., not receiving any treatment services) | Posted | Number | participants | 3 months |
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| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | Brief Intervention | Brief computer-delivered intervention following 5As/5Rs approach. | 0 | 55 | 0 | 55 |
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