SmokingPhase 2HPPNCT01028131
Computer-Assisted Intervention for Smoking During Pregnancy
A Phase 2 study testing Computer-delivered brief intervention (5As) and Contingency Management in people with Smoking, run by Wayne State University at 1 site in United States.
Trial summary
This study will develop: 1. Develop the computer-based brief intervention and Contingency Management (CM) components, with repeated feedback from experts, prenatal clinic staff, and participants. 2. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Smoking
- What is being tested?
- Computer-delivered brief intervention (5As) and Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jan 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years
- pregnant, gestation <= 27 weeks
- cigarette smoking in the past week (even if only one puff)
Who cannot join
- inability to speak or understand spoken English
- do not intend to carry pregnancy to full term
- frank psychosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Wayne State University-Detroit Medical Center
Detroit, Michigan, 48207
About this study
Official title: A Computer-Assisted Brief Motivational Intervention for Smoking During Pregnancy: The Healthy Pregnancy Project (HPP)
This study will develop:
- Develop the computer-based brief intervention and Contingency Management (CM) components, with repeated feedback from experts, prenatal clinic staff, and participants.
- Recruit 110 pregnant women who are actively smoking, and randomly assign recruited women to Brief Intervention, CM, combined, or control conditions.
- Conduct follow-up evaluation at 12 weeks post-intervention to measure self-reported smoking, breath carbon monoxide (CO), and urinary cotinine levels.
- Collect data regarding birth outcomes and evaluate the feasibility of various methods of post-partum follow-up.
Read the detailed description
Participants \& Procedure
Women will be approached while in the waiting room of various clinics at the Detroit Medical Center. Clinic staff will inform patients of the study and its goals via a flyer that will be distributed at the reception window as women arrive for their appointments. If the women are interested, they will answer some questions and provide their contact information on the back of the flyer. Then they will place the flyer in a ballot box that is locked and only can be accessed by the Research Staff. Research staff may also be at the clinic to recruit women from the waiting room. When the research staff meets with potential participants. The study will be briefly described, and those indicating tentative interest will be screened for age and language ability (informally). Those indicating tentative interest, reporting age of at least 18 years, gestation 27 weeks or less, and demonstrating adequate ability to speak and understand spoken English will be brought to a nearby private room.
First, informed consent for screening will be obtained using an information sheet; this sheet will describe the purpose of the screening, and will emphasize that participation in the initial screening is anonymous. Those who agree will be given a very brief demonstration of the use of the computer, after which they will complete the brief (10-item) screener. All interactions with the computer will involve a touch-screen and headphones for private presentation of all information aurally as well as visually; in many previous studies, including pilot testing at this clinic, the software has been proven extremely easy to use, even for women lacking any prior computer experience. Those who endorse smoking cigarettes (even a puff) in the past week will be told of the full study in detail, and written informed consent will be sought (with a brief quiz to assure understanding). Those who provide consent will again interact directly with the computer.
Intervention
The computer itself will perform randomization and will gather all research data except for baseline breath CO (which is higher among persons who smoke), which will be obtained (via a Micro Smokerlyzer® from Bedfont Scientific Ltd.) and entered into the computer by the research staff. The entire process, including consent, will take approximately 40 minutes regardless of experimental condition (to which the research staff will be blind). Research staff will tell clinic staff of the patient's whereabouts so that the patient is not passed over when staff call her to an exam room; unfinished study procedures will be completed in the exam room prior to the physician's entrance, and/or after the appointment is completed.
Women (N = 110) who report smoking cigarettes (even a puff) during pregnancy will be randomly assigned to computer-based brief intervention alone, CM alone, brief intervention plus CM, or attention control conditions. Women randomly assigned to the computer-based intervention condition will receive an approximately 20-minute intervention modeled after motivational interviewing (MI).
Women randomly assigned to the CM condition will be told that, if they choose, they can ask to be tested (via provision of a urine sample) for smoking, up to five times, at a regularly scheduled prenatal visit. Research staff will conduct these tests.
8-Week Follow-Up
Women who enroll in the study will be contacted via mail and telephone, as necessary, to schedule a 8-week follow-up at the PI's lab or at the prenatal clinic, depending upon the participant's preference. Research staff completing follow-up testing will be kept blind to intervention condition. The primary outcome measure will be urinary cotinine-verified abstinence at follow-up; birth outcome data will also be gathered from hospital records. At follow-up, participants will (a) complete all measures on the computer again, (b) provide breath CO; (c) provide a final urine sample for testing of urinary cotinine (evidence of smoking).
- Conditions
- Smoking
- Being tested
- Computer-delivered brief intervention (5As), Contingency Management
- Keywords
- cigarette smoking, pregnancy, intervention, efficacy, Motivational Interviewing, Contingency Management
- Medical subject headings
- Smoking, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-delivered brief intervention (5As)Behavioural
Also called Brief intervention, 5As, Brief motivational intervention
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 ManagementBehavioural
Also called Voucher-based reinforcement
Participants randomized by the computer into this condition will view a 20-minute music and tv videos after completing the brief assessment. The research assistant will then briefly describe the CM process, with a period for questions to assure understanding. The CM condition will involve participant-initiated submission of urine samples 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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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) | Experimental | 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 (ask, advise, assess, assist \& arrange) and Motivational Interviewing. Receives: Behavioral: Computer-delivered brief intervention (5As) |
| Contingency Management Alone | Experimental | 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. 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. Receives: Behavioral: Contingency Management |
| Combined Brief Intervention and CM | Experimental | Combined intervention. Participants in this condition will receive both the brief intervention and the brief description of the CM process. Receives: Behavioral: Computer-delivered brief intervention (5As); Behavioral: Contingency Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Behavior (Self-report Confirmed by Expired Breath CO)
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.
Measured: 8 week follow up
Urinary Cotinine
Cotinine, as measured by urine sample taken and follow-up. Measured as number of participants abstinent by cotinine analysis.
Measured: 8 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startJun 2007
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Steven J. Ondersma, Wayne State University
- Investigators
- Steven J Ondersma, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028131
- Sponsor's protocol ID
- R21DA021668-01
- Other IDs
- R21DA021668-02
- Acronym
- HPP
- Status last verified
- Jun 2013
- First submitted
- 8 Dec 2009
- Last updated
- 10 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ondersma SJ, Svikis DS, Lam PK, Connors-Burge VS, Ledgerwood DM, Hopper JA. A randomized trial of computer-delivered brief intervention and low-intensity contingency management for smoking during pregnancy. Nicotine Tob Res. 2012 Mar;14(3):351-60. doi: 10.1093/ntr/ntr221. Epub 2011 Dec 9.
PubMed 22157229
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Computer-Assisted Brief Motivational Intervention for Smoking During Pregnancy: The Healthy Pregnancy Project (HPP)
- ClinicalTrials.gov ID
- NCT01028131
- Acronym / sponsor ID
- HPP / R21DA021668-01
- Conditions
- Smoking
- Keywords
- cigarette smoking, pregnancy, intervention, efficacy, Motivational Interviewing, Contingency Management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 9 Dec 2009 (estimated)
- Results
- Posted 10 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will develop:
- Develop the computer-based brief intervention and Contingency Management (CM) components, with repeated feedback from experts, prenatal clinic staff, and participants.
- Recruit 110 pregnant women who are actively smoking, and randomly assign recruited women to Brief Intervention, CM, combined, or control conditions.
- Conduct follow-up evaluation at 12 weeks post-intervention to measure self-reported smoking, breath carbon monoxide (CO), and urinary cotinine levels.
- Collect data regarding birth outcomes and evaluate the feasibility of various methods of post-partum follow-up.
Detailed description
Participants \& Procedure
Women will be approached while in the waiting room of various clinics at the Detroit Medical Center. Clinic staff will inform patients of the study and its goals via a flyer that will be distributed at the reception window as women arrive for their appointments. If the women are interested, they will answer some questions and provide their contact information on the back of the flyer. Then they will place the flyer in a ballot box that is locked and only can be accessed by the Research Staff. Research staff may also be at the clinic to recruit women from the waiting room. When the research staff meets with potential participants. The study will be briefly described, and those indicating tentative interest will be screened for age and language ability (informally). Those indicating tentative interest, reporting age of at least 18 years, gestation 27 weeks or less, and demonstrating adequate ability to speak and understand spoken English will be brought to a nearby private room.
First, informed consent for screening will be obtained using an information sheet; this sheet will describe the purpose of the screening, and will emphasize that participation in the initial screening is anonymous. Those who agree will be given a very brief demonstration of the use of the computer, after which they will complete the brief (10-item) screener. All interactions with the computer will involve a touch-screen and headphones for private presentation of all information aurally as well as visually; in many previous studies, including pilot testing at this clinic, the software has been proven extremely easy to use, even for women lacking any prior computer experience. Those who endorse smoking cigarettes (even a puff) in the past week will be told of the full study in detail, and written informed consent will be sought (with a brief quiz to assure understanding). Those who provide consent will again interact directly with the computer.
Intervention
The computer itself will perform randomization and will gather all research data except for baseline breath CO (which is higher among persons who smoke), which will be obtained (via a Micro Smokerlyzer® from Bedfont Scientific Ltd.) and entered into the computer by the research staff. The entire process, including consent, will take approximately 40 minutes regardless of experimental condition (to which the research staff will be blind). Research staff will tell clinic staff of the patient's whereabouts so that the patient is not passed over when staff call her to an exam room; unfinished study procedures will be completed in the exam room prior to the physician's entrance, and/or after the appointment is completed.
Women (N = 110) who report smoking cigarettes (even a puff) during pregnancy will be randomly assigned to computer-based brief intervention alone, CM alone, brief intervention plus CM, or attention control conditions. Women randomly assigned to the computer-based intervention condition will receive an approximately 20-minute intervention modeled after motivational interviewing (MI).
Women randomly assigned to the CM condition will be told that, if they choose, they can ask to be tested (via provision of a urine sample) for smoking, up to five times, at a regularly scheduled prenatal visit. Research staff will conduct these tests.
8-Week Follow-Up
Women who enroll in the study will be contacted via mail and telephone, as necessary, to schedule a 8-week follow-up at the PI's lab or at the prenatal clinic, depending upon the participant's preference. Research staff completing follow-up testing will be kept blind to intervention condition. The primary outcome measure will be urinary cotinine-verified abstinence at follow-up; birth outcome data will also be gathered from hospital records. At follow-up, participants will (a) complete all measures on the computer again, (b) provide breath CO; (c) provide a final urine sample for testing of urinary cotinine (evidence of smoking).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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) | Experimental | Behavioral: Computer-delivered 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 (ask, advise, assess, assist \& arrange) and Motivational Interviewing. |
| Contingency Management Alone | Experimental | Behavioral: Contingency ManagementParticipants 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. 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 | Experimental | Behavioral: Computer-delivered brief intervention (5As), Behavioral: Contingency ManagementCombined intervention. Participants in this condition will receive both the brief intervention and the brief description of the CM process. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least 18 years
- pregnant, gestation <= 27 weeks
- cigarette smoking in the past week (even if only one puff)
Key exclusion criteria (3 listed)
- inability to speak or understand spoken English
- do not intend to carry pregnancy to full term
- frank psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-delivered brief intervention (5As)Also: Brief intervention, 5As, Brief motivational interventionAfter 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. | Behavioural | Combined Brief Intervention and CM, Computerized brief intervention (5As) |
| Contingency ManagementAlso: Voucher-based reinforcementParticipants randomized by the computer into this condition will view a 20-minute music and tv videos after completing the brief assessment. The research assistant will then briefly describe the CM process, with a period for questions to assure understanding. The CM condition will involve participant-initiated submission of urine samples 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. | Behavioural | Combined Brief Intervention and CM, Contingency Management Alone |
Primary outcome
Smoking Behavior (Self-report Confirmed by Expired Breath CO)
Time frame: 8 week follow up
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.
Urinary Cotinine
Time frame: 8 week follow-up
Cotinine, as measured by urine sample taken and follow-up. Measured as number of participants abstinent by cotinine analysis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22157229Ondersma SJ, Svikis DS, Lam PK, Connors-Burge VS, Ledgerwood DM, Hopper JA. A randomized trial of computer-delivered brief intervention and low-intensity contingency management for smoking during pregnancy. Nicotine Tob Res. 2012 Mar;14(3):351-60. doi: 10.1093/ntr/ntr221. Epub 2011 Dec 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven J Ondersma, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Computer-delivered brief intervention (5As) and Contingency Management in people with Smoking, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Behavior (Self-report Confirmed by Expired Breath CO) (time frame: 8 week follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01028131, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2013.