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

July 29, 2014 updated by: University of Chicago

Use of Motivational Interviewing to Increase Contraception Use Among Young Women: a Randomized Control Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60615
        • University of Chicago Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 29 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Use of very effective contraception
Time Frame: up to 3 months after termination of pregnancy appointment
up to 3 months after termination of pregnancy appointment

Secondary Outcome Measures

Outcome Measure
Time Frame
Correct, consistent use of contraceptive method
Time Frame: up to 3 months
up to 3 months
Use of any contraceptive method
Time Frame: up to 3 months
up to 3 months
Contraceptive method satisfaction
Time Frame: up to 3 months
up to 3 months
Intention to continue current method
Time Frame: up to 3 months
up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Amy Whitaker, MD MS, University Of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

June 17, 2013

First Submitted That Met QC Criteria

June 18, 2013

First Posted (Estimate)

June 19, 2013

Study Record Updates

Last Update Posted (Estimate)

July 30, 2014

Last Update Submitted That Met QC Criteria

July 29, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 130108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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