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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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Pilot trial of computer-based motivational intervention. Hypothesis: The brief computer-delivered intervention would result in higher motivation to change at follow-up.
Participants were randomized into brief intervention vs. assessment-only conditions, with follow-up to measure overall motivation to change.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief computer-delivered intervention | Experimental | A 20-minute interaction with software designed to partially replicate the experience of a brief motivational intervention with a therapist or health care professional. Included decisional balance, normed feedback, and optional goal-setting. |
|
| Assessment only | No Intervention | Participants in this arm only completed assessment section, same as intervention group, but then was done. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief computer-delivered intervention | Behavioral | 20-minute interaction with voice-enabled software that could provide reflections, images, text, etc. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Motivation to Change Substance Use | An eight-item measure tapping motivation to change, self-efficacy, and change intention was assessed using visual analog scales. The average of the eight items was calculated resulting in a score ranging from 1 to 100. The measure was asked at baseline (reported in baseline data) and the one month follow-up. Scores here represent average level of motivation for change at the time of follow-up. Higher scores represent higher levels of motivation to change, self-efficacy and intention to change. | One month |
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Woman in immediate post-partum period
Inclusion Criteria:
Self-report of drug use prior to pregnancy
Exclusion Criteria:
Frank psychosis or other cognitive impairment; inability to communicate in English; fatigue; recent receipt of narcotic pain medication; grieving over medically compromised infant
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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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Brief Computer-delivered Motivational Intervention | Brief computer-delivered intervention in three components: decisional balance, feedback, and optional goal setting. |
| FG001 | Assessment Only | Only assessment, same as completed by intervention group. No further interaction with computer. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Brief Computer-delivered Motivational Intervention | Brief computer-delivered intervention in three components: decisional balance, feedback, and optional goal setting. |
| BG001 | Assessment Only |
| 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 | Motivation to Change Substance Use | An eight-item measure tapping motivation to change, self-efficacy, and change intention was assessed using visual analog scales. The average of the eight items was calculated resulting in a score ranging from 1 to 100. The measure was asked at baseline (reported in baseline data) and the one month follow-up. Scores here represent average level of motivation for change at the time of follow-up. Higher scores represent higher levels of motivation to change, self-efficacy and intention to change. | A total of 30 participants were included in this pilot trial, based primarily on convenience and timeframe. The primary goal was effect-size estimation, so power was not a primary concern. Last Observation Carried Forward(LOCF) was utilized for 8 participants lost to follow-up. | Posted | Mean | Standard Deviation | units on a scale | One month |
|
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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 | Brief Computer-delivered Motivational Intervention | Brief computer-delivered intervention in three components: decisional balance, feedback, and optional goal setting. |
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Small sample size in the pilot clinical trial. Because of this lack of power, a statistically significant difference between groups was not demonstrated, and the 95% Confidence Interval (CI) for the effect size estimate included zero.
| 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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Only assessment, same as completed by intervention group. No further interaction with computer.
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Baseline motivation | Visual analog scale questions were used to assess baseline motivation, self-efficacy, problem recognition, and change likelihood. The average of the items were calculated for baseline measurement resulting in a score ranging from 1 to 100. Higher scores represent increase motivation for change, self-efficacy, problem recognition and increased likelihood of making a change. | Mean | Standard Deviation | units on a scale |
|
A brief assessment, plus a brief (20-minute) motivational intervention delivered solely by computer. The software was synchronously interactive and followed a traditional motivational interviewing approach.
| OG001 | Assessment Only | Only assessment measures with no subsequent intervention. |
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Assessment Only | Only assessment, same as completed by intervention group. No further interaction with computer. | 0 | 15 | 0 | 15 |
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