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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

About this study

Official title: A Computer-Assisted Brief Motivational Intervention for Smoking During Pregnancy: The Healthy Pregnancy Project (HPP)

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. Recruit 110 pregnant women who are actively smoking, and randomly assign recruited women to Brief Intervention, CM, combined, or control conditions.
  3. Conduct follow-up evaluation at 12 weeks post-intervention to measure self-reported smoking, breath carbon monoxide (CO), and urinary cotinine levels.
  4. 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 groups in NCT01028131
Study groupRoleWhat they receive
ControlNo interventionParticipants randomized by the computer into this condition will only view the 20-minute video clips of music and tv videos.
Computerized brief intervention (5As)ExperimentalAfter 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 AloneExperimentalParticipants 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 CMExperimentalCombined 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.

  1. 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

  2. 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.

  1. First posted9 Dec 2009 (estimated)
  2. Study startJun 2007
  3. Primary completionJan 2010
  4. Study completionJan 2010

Resources

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)
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
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

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.

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