Use of Motivational Interviewing to Increase Contraception Use Among Young Women

Unplanned Pregnancy Clinical Trial

— MI RCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01881321
• Other study ID #: 130108
• Status: Completed
• Phase: N/A
• First received: June 17, 2013
• Last updated: July 29, 2014
• Start date: June 2013
• Est. completion date: March 2014

Study information

• Verified date: July 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 29 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Unplanned Pregnancy

Intervention

Behavioral:
• Counseling Intervention
20-40 minute contraceptive counseling session based on the principles of motivational interviewing

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of very effective contraception		up to 3 months after termination of pregnancy appointment	No
Secondary	Correct, consistent use of contraceptive method		up to 3 months	No
Secondary	Use of any contraceptive method		up to 3 months	No
Secondary	Contraceptive method satisfaction		up to 3 months	No
Secondary	Intention to continue current method		up to 3 months	No