Unplanned PregnancyMI RCTNCT01881321
Use of Motivational Interviewing to Increase Contraception Use Among Young Women
A study testing Counseling Intervention in people with Unplanned Pregnancy, run by University of Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 15 to 29 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Unplanned Pregnancy
- What is being tested?
- Counseling Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 29 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60615
About this study
Official title: 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:
Read more
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.
- Conditions
- Unplanned Pregnancy
- Being tested
- Counseling Intervention
- Keywords
- Contraception, Counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counseling InterventionBehavioural
20-40 minute contraceptive counseling session based on the principles of motivational interviewing
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Counseling Intervention | Experimental | Contraceptive counseling session based on the principles of motivational interviewing Receives: Behavioral: Counseling Intervention |
| Group 2: Usual Care | No intervention | The standard clinic-based contraceptive counseling with no additional or theory-based contraceptive counseling session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of very effective contraception
Measured: up to 3 months after termination of pregnancy appointment
Secondary outcomes (4)
Correct, consistent use of contraceptive method
Measured: up to 3 months
Use of any contraceptive method
Measured: up to 3 months
Contraceptive method satisfaction
Measured: up to 3 months
Intention to continue current method
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Unplanned PregnancyStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy Whitaker, MD MS, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881321
- Sponsor's protocol ID
- 130108
- Acronym
- MI RCT
- Status last verified
- Jul 2014
- First submitted
- 17 Jun 2013
- Last updated
- 30 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30685284Whitaker 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.
PubMed 27211225
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Motivational Interviewing to Increase Contraception Use Among Young Women: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01881321
- Acronym / sponsor ID
- MI RCT / 130108
- Conditions
- Unplanned Pregnancy
- Keywords
- Contraception, Counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 19 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Counseling Intervention | Experimental | Behavioral: Counseling InterventionContraceptive counseling session based on the principles of motivational interviewing |
| Group 2: Usual Care | No intervention | –The standard clinic-based contraceptive counseling with no additional or theory-based contraceptive counseling session |
Who may qualify
- Ages
- 15 to 29 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Counseling Intervention20-40 minute contraceptive counseling session based on the principles of motivational interviewing | Behavioural | Group 1: Counseling Intervention |
Primary outcome
Use of very effective contraception
Time frame: up to 3 months after termination of pregnancy appointment
4 secondary outcomes
Correct, consistent use of contraceptive method
Time frame: up to 3 months
Use of any contraceptive method
Time frame: up to 3 months
Contraceptive method satisfaction
Time frame: up to 3 months
Intention to continue current method
Time frame: up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2014.
- Derived from this study: PubMed 30685284Brown 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.
- Derived from this study: PubMed 27211225Whitaker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Whitaker, MD MS principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling Intervention in people with Unplanned Pregnancy, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of very effective contraception (time frame: up to 3 months after termination of pregnancy appointment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01881321, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2014.