CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 110 enrolled
Drug / intervention
Computer-delivered brief intervention (5As) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01028131
NCT01028131Phase 2Completed

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

Wayne State University·interventional·Posted Dec 9, 2009·Updated Jun 10, 2013

In Brief

A Phase 2 clinical trial evaluating Computer-delivered brief intervention (5As) and Contingency Management for Smoking. Completed, enrolled 110 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking
CountriesUnited States

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 9, 2009
Enrollment StartJun 1, 2007
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 16.6 years ago

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.

Contingency Managementbehavioral

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.