Trial Outcomes & Findings for Interactive Motivational Media for Perinatal Drug Abuse - 3 (NCT NCT00230048)

NCT ID: NCT00230048

Last Updated: 2012-10-31

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 107 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2012-10-31

Participant Flow

Participant milestones

Measure	Assessment Only This arm answered questions only, but received no intervention.	Brief Intervention Brief computer-delivered intervention following motivational approach, adapted from Motivational Interviewing: Decisional balance, normed feedback, and optional goal-setting.
Overall Study STARTED	52	55
Overall Study Completed Intervention/Control Session	52	55
Overall Study COMPLETED	39	37
Overall Study NOT COMPLETED	13	18

Reasons for withdrawal

Measure	Assessment Only This arm answered questions only, but received no intervention.	Brief Intervention Brief computer-delivered intervention following motivational approach, adapted from Motivational Interviewing: Decisional balance, normed feedback, and optional goal-setting.
Overall Study Lost to Follow-up	13	18

Baseline Characteristics

Interactive Motivational Media for Perinatal Drug Abuse - 3

Baseline characteristics by cohort

Measure	Assessment Only n=52 Participants This arm answered questions only, but received no intervention.	Brief Intervention n=55 Participants Brief computer-delivered intervention following 5As/5Rs approach.	Total n=107 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=5 Participants	55 Participants n=7 Participants	107 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	24.2 years STANDARD_DEVIATION 5.4 • n=5 Participants	25.9 years STANDARD_DEVIATION 5.7 • n=7 Participants	25.1 years STANDARD_DEVIATION 5.6 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	55 Participants n=7 Participants	107 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	52 participants n=5 Participants	55 participants n=7 Participants	107 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Intent to treat, treating participants lost to follow-up as positive.

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.

Outcome measures

Measure	Assessment Only n=52 Participants Assessment only, via computer.	Brief Intervention n=55 Participants Assessment plus 20-minute interactive session with computer, designed to be maximally similar to a therapist-delivered motivational session.
Number of Participants With Drug Use at 3 Months	49 participants	48 participants

PRIMARY outcome

Timeframe: 3 months

Population: ITT, treating all participants lost to follow up as failures (i.e., not receiving any treatment services)

Completing at least a single intake or treatment session of any kind, focused on substance use within the previous 3 months.

Outcome measures

Measure	Assessment Only n=52 Participants Assessment only, via computer.	Brief Intervention n=55 Participants Assessment plus 20-minute interactive session with computer, designed to be maximally similar to a therapist-delivered motivational session.
Treatment Engagement	1 participants	0 participants

Adverse Events

Assessment Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Brief Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Steven J. Ondersma

Wayne State University

Phone: 313-577-6680

Email: s.ondersma@wayne.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place