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Computer-Assisted Intervention for Smoking During Pregnancy (HPP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Wayne State University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
Wayne State University
ClinicalTrials.gov Identifier:
NCT01028131
First received: December 8, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

This study will develop:

  1. Develop the computer-based brief intervention and 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 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 During Pregnancy
 Behavioral: Computer-delivered brief intervention (5As)
Behavioral: Contingency Management
 Phase 1
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:

U.S. FDA Resources

Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • Smoking Behavior (self-report; urinalysis for cotinine; Expired breath CO) [ Time Frame: 8 week follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Medical record data: child birthweight, size for gestational age, preterm delivery, and days in the NICU [ Time Frame: Post Partem ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: June 2007
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 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 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. Clean samples (cotinine less than 100 ng/ml) will result in the immediate provision of a $50 Target gift card. 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. Clean samples (cotinine less than 100 ng/ml) will result in the immediate provision of a $50 Target gift card. 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. Clean samples (cotinine less than 100 ng/ml) will result in the immediate provision of a $50 Target gift card. 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
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
National Institute on Drug Abuse (NIDA)
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
Last Updated: December 8, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on May 16, 2013