Computer-Assisted Intervention for Smoking During Pregnancy

NCT01028131 | Completed Phase 2 Results

• 2 other identifiers: R21DA021668-01R21DA021668-02
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This study will develop:

1. 1.Develop the computer-based brief intervention and Contingency Management (CM) components, with repeated feedback from experts, prenatal clinic staff, and participants.
2. 2.Recruit 110 pregnant women who are actively smoking, and randomly assign recruited women to Brief Intervention, CM, combined, or control conditions.
3. 3.Conduct follow-up evaluation at 12 weeks post-intervention to measure self-reported smoking, breath carbon monoxide (CO), and urinary cotinine levels.
4. 4.Collect data regarding birth outcomes and evaluate the feasibility of various methods of post-partum follow-up.

Conditions

Smoking

Keywords

cigarette smoking; pregnancy; intervention; efficacy; Motivational Interviewing; Contingency Management

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (4)

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.

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.

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.

Behavioral: Computer-delivered brief intervention (5As); Behavioral: Contingency Management

Interventions

Computer-delivered brief intervention (5As) BEHAVIORAL

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.

Also known as: Brief intervention, 5As, Brief motivational intervention

Combined Brief Intervention and CM; Computerized brief intervention (5As)

Contingency Management BEHAVIORAL

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.

Also known as: Voucher-based reinforcement

Combined Brief Intervention and CM; Contingency Management Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 18 years
• pregnant, gestation \<= 27 weeks
• cigarette smoking in the past week (even if only one puff)

You may not qualify if:

• inability to speak or understand spoken English
• do not intend to carry pregnancy to full term
• frank psychosis

Sponsors & Collaborators

• Wayne State University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Wayne State University-Detroit Medical Center

Detroit, Michigan, 48207, United States

Location

Related Publications (1)

• 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.

  PMID: 22157229 DERIVED

MeSH Terms

Conditions

Smoking; Cigarette Smoking

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Behavior; Tobacco Smoking; Tobacco Use

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Although all effects favored brief computer session, the small sample size limited our ability to detect small effects. The sample was almost exclusively low-income African-American women. Follow-up period was also, of necessity, relatively brief.

Results Point of Contact

• Title: Steven J. Ondersma
• Organization: Wayne State University

s.ondersma@wayne.edu

313-577-6680

Study Officials

• Steven J Ondersma, PhD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 8, 2009
• First Posted: December 9, 2009
• Study Start: June 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: June 10, 2013
• Results First Posted: June 10, 2013

Record last verified: 2013-06

Locations

US (1)