NCT01881321

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

July 30, 2014

Status Verified

July 1, 2014

Enrollment Period

9 months

First QC Date

June 17, 2013

Last Update Submit

July 29, 2014

Conditions

Unplanned Pregnancy

Keywords

ContraceptionCounseling

Outcome Measures

Primary Outcomes (1)

  • Use of very effective contraception

    up to 3 months after termination of pregnancy appointment

Secondary Outcomes (4)

  • Correct, consistent use of contraceptive method

    up to 3 months

  • Use of any contraceptive method

    up to 3 months

  • Contraceptive method satisfaction

    up to 3 months

  • Intention to continue current method

    up to 3 months

Study Arms (2)

Group 1: Counseling Intervention

EXPERIMENTAL

Contraceptive counseling session based on the principles of motivational interviewing

Behavioral: Counseling Intervention

Group 2: Usual Care

NO INTERVENTION

The standard clinic-based contraceptive counseling with no additional or theory-based contraceptive counseling session

Interventions

Counseling InterventionBEHAVIORAL

20-40 minute contraceptive counseling session based on the principles of motivational interviewing

Group 1: Counseling Intervention

Eligibility Criteria

Age15 Years - 29 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Current pregnancy intended
  • Current pregnancy desired
  • Reason for pregnancy termination not elective (e.g. fetal anomalies, pregnancy resulted from rape or incest)
  • Plans pregnancy within 6 months
  • Has been administered any sedatives or cervical ripening agents
  • For minors, must not be a ward of the state.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60615, United States

Location

Related Publications (2)

  • Brown BP, Chor J, Hebert LE, Webb ME, Whitaker AK. Shared negative experiences of long-acting reversible contraception and their influence on contraceptive decision-making: a multi-methods study. Contraception. 2019 Apr;99(4):228-232. doi: 10.1016/j.contraception.2019.01.002. Epub 2019 Jan 24.

    PMID: 30685284DERIVED

  • Whitaker AK, Quinn MT, Munroe E, Martins SL, Mistretta SQ, Gilliam ML. A motivational interviewing-based counseling intervention to increase postabortion uptake of contraception: A pilot randomized controlled trial. Patient Educ Couns. 2016 Oct;99(10):1663-9. doi: 10.1016/j.pec.2016.05.011. Epub 2016 May 9.

    PMID: 27211225DERIVED

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Amy Whitaker, MD MS

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2013

First Posted

June 19, 2013

Study Start

June 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

July 30, 2014

Record last verified: 2014-07

Locations

US(1)