Computer-Assisted Intervention for Smoking During Pregnancy (HPP)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven J. Ondersma, Wayne State University
ClinicalTrials.gov Identifier:
NCT01028131
First received: December 8, 2009
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

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.

Condition Intervention Phase
Smoking
Behavioral: Computer-delivered brief intervention (5As)
Behavioral: Contingency Management
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Computer-Assisted Brief Motivational Intervention for Smoking During Pregnancy: The Healthy Pregnancy Project (HPP)

Resource links provided by NLM:


Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • Smoking Behavior (Self-report Confirmed by Expired Breath CO) [ Time Frame: 8 week follow up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Cotinine, as measured by urine sample taken and follow-up. Measured as number of participants abstinent by cotinine analysis.


Enrollment: 110
Study Start Date: June 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Participants randomized by the computer into this condition will only view the 20-minute video clips of music and tv videos.
Experimental: 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 (ask, advise, assess, assist & arrange) and Motivational Interviewing.
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.
Other Names:
  • Brief intervention
  • 5As
  • Brief motivational intervention
Experimental: 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 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.
Behavioral: 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.
Other Name: Voucher-based reinforcement
Experimental: 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.
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.
Other Names:
  • Brief intervention
  • 5As
  • Brief motivational intervention
Behavioral: 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.
Other Name: Voucher-based reinforcement

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01028131

Locations
United States, Michigan
Wayne State University-Detroit Medical Center
Detroit, Michigan, United States, 48207
Sponsors and Collaborators
Wayne State University
Investigators
Principal Investigator: Steven J Ondersma, PhD Wayne State University
  More Information

No publications provided by Wayne State University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven J. Ondersma, Associate Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT01028131     History of Changes
Other Study ID Numbers: R21 DA021668-01, R21DA021668-02
Study First Received: December 8, 2009
Results First Received: October 12, 2011
Last Updated: June 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Wayne State University:
cigarette smoking
pregnancy
intervention
efficacy
Motivational Interviewing
Contingency Management

ClinicalTrials.gov processed this record on October 30, 2014