Substance-Related Disorders
Conditions
Brief summary
Interactive Motivational Media for Perinatal Drug Abuse
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.
Interventions
BEHAVIORALBrief computer-delivered intervention
Brief (20-minute) computer delivered intervention, plus two subsequent non-tailored mailings.
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Drug Use at 3 Months | 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. |
| Treatment Engagement | 3 months | Completing at least a single intake or treatment session of any kind, focused on substance use within the previous 3 months. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Assessment Only This arm answered questions only, but received no intervention. | 52 |
| Brief Intervention Brief computer-delivered intervention following 5As/5Rs approach. | 55 |
| Total | 107 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 13 | 18 |
Baseline characteristics
| Characteristic | Brief 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 | 55 Participants | 52 Participants | 107 Participants |
| Age Continuous | 25.9 years STANDARD_DEVIATION 5.7 | 24.2 years STANDARD_DEVIATION 5.4 | 25.1 years STANDARD_DEVIATION 5.6 |
| Region of Enrollment United States | 55 participants | 52 participants | 107 participants |
| Sex: Female, Male Female | 55 Participants | 52 Participants | 107 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 / 52 | 0 / 55 |
| serious Total, serious adverse events | 0 / 52 | 0 / 55 |
Outcome results
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.
Time frame: 3 months
Population: Intent to treat, treating participants lost to follow-up as positive.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Assessment Only | Number of Participants With Drug Use at 3 Months | 49 participants |
| Brief Intervention | Number of Participants With Drug Use at 3 Months | 48 participants |
Primary
Treatment Engagement
Completing at least a single intake or treatment session of any kind, focused on substance use within the previous 3 months.
Time frame: 3 months
Population: ITT, treating all participants lost to follow up as failures (i.e., not receiving any treatment services)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Assessment Only | Treatment Engagement | 1 participants |
| Brief Intervention | Treatment Engagement | 0 participants |