Substance-Related Disorders
Conditions
Brief summary
Pilot trial of computer-based motivational intervention. Hypothesis: The brief computer-delivered intervention would result in higher motivation to change at follow-up.
Detailed description
Participants were randomized into brief intervention vs. assessment-only conditions, with follow-up to measure overall motivation to change.
Interventions
BEHAVIORALBrief computer-delivered intervention
20-minute interaction with voice-enabled software that could provide reflections, images, text, etc.
Sponsors
National Institute on Drug Abuse (NIDA)
Wayne State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motivation to Change Substance Use | One month | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Brief Computer-delivered Motivational Intervention Brief computer-delivered intervention in three components: decisional balance, feedback, and optional goal setting. | 15 |
| Assessment Only Only assessment, same as completed by intervention group. No further interaction with computer. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Brief Computer-delivered Motivational Intervention | Assessment Only | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 15 Participants | 30 Participants |
| Baseline motivation | 82.5 units on a scale STANDARD_DEVIATION 18.9 | 79.5 units on a scale STANDARD_DEVIATION 21.2 | 81.0 units on a scale STANDARD_DEVIATION 20.3 |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 15 Participants | 15 Participants | 30 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
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.
Time frame: One month
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Computer-delivered Motivational Intervention | Motivation to Change Substance Use | 88.8 units on a scale | Standard Deviation 10 |
| Assessment Only | Motivation to Change Substance Use | 77.4 units on a scale | Standard Deviation 20 |