Computer-Assisted Intervention for Smoking During Pregnancy

Smoking Clinical Trial

— HPP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01028131
• Other study ID #: R21DA021668-01
• Secondary ID: R21DA021668-02
• Status: Completed
• Phase: Phase 2
• First received: December 8, 2009
• Last updated: June 6, 2013
• Start date: June 2007
• Est. completion date: January 2010

Study information

• Verified date: June 2013
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• at least 18 years

• pregnant, gestation <= 27 weeks

• cigarette smoking in the past week (even if only one puff)

Exclusion Criteria:

• inability to speak or understand spoken English

• do not intend to carry pregnancy to full term

• frank psychosis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking

Intervention

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 and Motivational Interviewing.
• Contingency Management
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.

Locations

Country	Name	City	State
United States	Wayne State University-Detroit Medical Center	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Wayne State University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 week follow up	No
Primary	Urinary Cotinine	Cotinine, as measured by urine sample taken and follow-up. Measured as number of participants abstinent by cotinine analysis.	8 week follow-up	No