Planning Together: A Couple-based, Multi-level Prenatal Contraceptive Education Program for Economically Marginalized Families

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Tennessee Graduate School of Medicine

About this trial

The goal of this pilot trial is to examine the feasibility and acceptability of the Planning Together protocol

The hypothesis of this study are

1. The study will achieve feasibility, demonstrated by ≥80% study accrual (30 couples in 8 months), ≥75% protocol adherence, and ≥75% (e.g., education workbook completion) 2. The intervention will be acceptable, with \>80% of participants reporting satisfaction with Planning Together. 3. Patterns of primary outcomes (contraceptive knowledge, communication quality, community referral utilization) and secondary outcomes (agreed contraceptive plan, consistent contraceptive usage and satisfaction, psychological distress, and Short Interpregnancy Intervals \[SII\]) will suggest benefits of the intervention.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

> 20 weeks pregnant, age 18+

The pregnant person has an available romantic partner, and the couple was able to get pregnant on their own or will be able to after the delivery

separately, the pregnant person reports being in a sexually, psychologically and physically safe relationship

English-speaking

Disqualifiers

Participant is under the age of 18

Documented cognitive impairment or psychiatric condition in pregnant person's medical record (e.g., severe learning disability, dementia, current psychotic disorder, suicidality)

Participation in a concurrent contraceptive education intervention

The pregnant person has a high-risk medical condition

Trial design

Design model

Single group

Treatments tested in this trial

  • Joint contraceptive and couple communication education

    Other intervention

    Joint Comprehensive Contraceptive Education a. Visual and written description of all currently available contraceptives with explanation of pros and cons Couple constructive communication education 1. Specific couple contraceptive conversation examples. 2. Interactive worksheet to help with joint desired contraceptive decision-making and making a consistent use plan

  • Couple communication consultation with Interventionist to increase partner engagement and improve communication

    Other intervention

    1. Couples will bring their completed workbook to reference during the meeting and assess fidelity 2. Reinforce couple contraceptive communication skills. Address any challenges couple has with skill implementation 3. Review desired contraceptive method \& consistent use plan 4. Use motivational interviewing techniques to help couple agree on contraceptive plan

  • Check-ins to support continued partner support & communication

    Other intervention

    1. Review progress toward couple contraceptive communication skills and use of agreed contraceptive method 2. Assess factors promoting successful contraceptive use and communication skills 3. Address barriers to consistent contraceptive use and communication skill implementation via shared problem-solving

  • Check-ins to support continued partner support & communication

    Other intervention

    1. Review progress toward couple contraceptive communication skills and use of agreed contraceptive method 2. Assess factors promoting successful contraceptive use and communication skills 3. Address barriers to consistent contraceptive use and communication skill implementation via shared problem-solving

Treatment groups

60 Participants
are divided into 4 treatment groups
Group A: Communication and Contraceptive Education Workbook (60-90 minutes)Other 1 intervention
Group B: Couple Contraceptive Consultation (60-90 minutes)Other 1 intervention
Group C: Booster Check-ins (~30 minutes)Other 1 intervention
Group D: Booster Check-ins (~30 minutes.)Other 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of Study Procedures

Defined as ≥80% study accrual (30 couples in 8 months), ≥75% protocol adherence, and ≥75% fidelity (completion of workbook and study activities)

Time frame
Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum
2

Acceptability of the Intervention

Measured by survey item: \>80% of participants will report satisfaction with Planning Together using a Program Satisfaction questionnaire

Time frame
Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum
3

Change in Contraceptive Knowledge

Measured using the validated Contraceptive Knowledge tool

Time frame
Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum
4

Change in Couple Communication Quality

Assessed with the Communication Problems Questionnaire (CPQ)

Time frame
Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum

Secondary outcomes

1

Consistent Contraceptive Usage

Measured by participant self-report on the Consistent Usage scale

Time frame
6-week postpartum and 12-week postpartum
2

Satisfaction with Agreed Contraceptive Method

Assessed via the validated Satisfaction of Agreed Method scale

Time frame
6-week postpartum and 12-week postpartum
3

Relationship Satisfaction

Measured using the Couple Satisfaction Index (CSI)

Time frame
Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum
4

Psychological Distress - Anxiety

Measured using PROMIS Anxiety short form

Time frame
Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Tennessee Graduate School of Medicine

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator