Trial Outcomes & Findings for Computer-Assisted Intervention for Smoking During Pregnancy (NCT NCT01028131)
NCT ID: NCT01028131
Last Updated: 2013-06-10
Results Overview
All participants were analyzed as assigned. Total N was determined primarily by resource availability in this Stage Ib trial. Number represents number of abstinent participants in each condition.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
110 participants
Primary outcome timeframe
8 week follow up
Results posted on
2013-06-10
Participant Flow
Participant milestones
| Measure |
Control
Participants randomized by the computer into this condition will only view the 20-minute video clips of music and tv videos.
|
Computerized Brief Intervention (5As)
After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.
|
Contingency Management Alone
Participants randomized by the computer into this condition will view a 20-minute music and tv video clip after completing the brief assessment. The research assistant will then briefly describe the CM process, with some time to discuss questions regarding procedure to assure understanding. The CM condition will involve participant-initiated submission of urine samples(looking for clean samples with cotinine less than 100 ng/ml) at prenatal visits. Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
|
Combined Brief Intervention and CM
Combined intervention. Participants in this condition will receive both the brief intervention and the brief description of the CM process.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
28
|
30
|
|
Overall Study
Completed Intervention/Control Session
|
26
|
26
|
28
|
30
|
|
Overall Study
COMPLETED
|
23
|
23
|
22
|
26
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
6
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Computer-Assisted Intervention for Smoking During Pregnancy
Baseline characteristics by cohort
| Measure |
Control
n=26 Participants
Participants randomized by the computer into this condition will only view the 20-minute video clips of music and tv videos.
|
Computerized Brief Intervention (5As)
n=26 Participants
After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.
|
Contingency Management Alone
n=28 Participants
Participants randomized by the computer into this condition will view a 20-minute music and tv video clip after completing the brief assessment. The research assistant will then briefly describe the CM process, with some time to discuss questions regarding procedure to assure understanding. The CM condition will involve participant-initiated submission of urine samples at prenatal visits (looking for clean samples - cotinine less than 100 ng/ml). Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
|
Combined Brief Intervention and CM
n=30 Participants
Combined intervention. Participants in this condition will receive both the brief intervention and the brief description of the CM process.
|
Total
n=110 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
110 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age Continuous
|
28.5 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
25.8 years
STANDARD_DEVIATION 4.8 • n=7 Participants
|
29.3 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
27.7 years
STANDARD_DEVIATION 6.1 • n=4 Participants
|
27.9 years
STANDARD_DEVIATION 6.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
110 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
26 participants
n=7 Participants
|
28 participants
n=5 Participants
|
30 participants
n=4 Participants
|
110 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 8 week follow upAll participants were analyzed as assigned. Total N was determined primarily by resource availability in this Stage Ib trial. Number represents number of abstinent participants in each condition.
Outcome measures
| Measure |
Control
n=23 Participants
Participants randomized by the computer into this condition will only view the 20-minute video clips of music and tv videos.
|
Computerized Brief Intervention (5As)
n=23 Participants
After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.
|
Contingency Management Alone
n=22 Participants
Participants randomized by the computer into this condition will view a 20-minute music and tv video clip after completing the brief assessment. The research assistant will then briefly describe the CM process, with some time to discuss questions regarding procedure to assure understanding. The CM condition will involve participant-initiated submission of urine samples at prenatal visits (looking for clean samples -cotinine less than 100 ng/ml). Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
|
Combined Brief Intervention and CM
n=26 Participants
Combined intervention. Participants in this condition will receive both the brief intervention and the brief description of the CM process.
|
|---|---|---|---|---|
|
Smoking Behavior (Self-report Confirmed by Expired Breath CO)
|
2 participants
|
7 participants
|
2 participants
|
5 participants
|
PRIMARY outcome
Timeframe: 8 week follow-upCotinine, as measured by urine sample taken and follow-up. Measured as number of participants abstinent by cotinine analysis.
Outcome measures
| Measure |
Control
n=23 Participants
Participants randomized by the computer into this condition will only view the 20-minute video clips of music and tv videos.
|
Computerized Brief Intervention (5As)
n=23 Participants
After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.
|
Contingency Management Alone
n=22 Participants
Participants randomized by the computer into this condition will view a 20-minute music and tv video clip after completing the brief assessment. The research assistant will then briefly describe the CM process, with some time to discuss questions regarding procedure to assure understanding. The CM condition will involve participant-initiated submission of urine samples at prenatal visits (looking for clean samples -cotinine less than 100 ng/ml). Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
|
Combined Brief Intervention and CM
n=26 Participants
Combined intervention. Participants in this condition will receive both the brief intervention and the brief description of the CM process.
|
|---|---|---|---|---|
|
Urinary Cotinine
|
4 participants
|
10 participants
|
3 participants
|
4 participants
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Computerized Brief Intervention (5As)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Contingency Management Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Combined Brief Intervention and CM
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place