Use of Motivational Interviewing to Increase Contraception Use Among Young Women (MI RCT)

This study is currently recruiting participants.
Verified June 2013 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01881321
First received: June 17, 2013
Last updated: September 4, 2013
Last verified: June 2013
  Purpose

Study design: This is a 2-phase study. During the first phase, the investigators developed a contraceptive counseling intervention based on the principles of Motivational Interviewing, trained counselors, and conducted a small pilot study to develop skills and refine the intervention.

The second phase is this feasibility randomized controlled trial (RCT) to compare outcomes between:

Group 1 - Women randomized to a 20-40 minute contraceptive counseling session based on the principles of motivational interviewing, vs.

Group 2 - Women receiving usual clinic care.

Population: Women, aged 15-29 years, presenting to the University of Chicago family planning clinic for termination of an unintended pregnancy.

Hypothesis: A larger proportion of women who are randomized to receive the MI counseling intervention will be using very effective contraception 3 months after the intervention.


Condition Intervention
Unplanned Pregnancy
Behavioral: Counseling Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Use of Motivational Interviewing to Increase Contraception Use Among Young Women: a Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Use of very effective contraception [ Time Frame: up to 3 months after termination of pregnancy appointment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correct, consistent use of contraceptive method [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
  • Use of any contraceptive method [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
  • Contraceptive method satisfaction [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
  • Intention to continue current method [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: Counseling Intervention
Contraceptive counseling session based on the principles of motivational interviewing
Behavioral: Counseling Intervention
20-40 minute contraceptive counseling session based on the principles of motivational interviewing
No Intervention: Group 2: Usual Care
The standard clinic-based contraceptive counseling with no additional or theory-based contraceptive counseling session

  Eligibility

Ages Eligible for Study:   15 Years to 29 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Aged 15-29 years
  2. Presenting for elective termination of an unintended pregnancy
  3. Has not had contraceptive counseling from the team.
  4. Willing and able to understand and comply with study protocol
  5. Willing and able to sign an informed consent in English

Exclusion Criteria:

  1. Current pregnancy intended
  2. Current pregnancy desired
  3. Reason for pregnancy termination not elective (e.g. fetal anomalies, pregnancy resulted from rape or incest)
  4. Plans pregnancy within 6 months
  5. Has been administered any sedatives or cervical ripening agents
  6. For minors, must not be a ward of the state.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01881321

Contacts
Contact: Amy Whitaker, MD, MS (773) 834-4129 awhitaker@babies.bsd.uchicago.edu

Locations
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60615
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Amy Whitaker, MD MS University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01881321     History of Changes
Other Study ID Numbers: 130108
Study First Received: June 17, 2013
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Contraception
Counseling

ClinicalTrials.gov processed this record on April 16, 2014