- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00243997
Evaluation of the Efficacy of the Becoming Parents Program
Study of the Effects of the Becoming Parents Program on Couples Becoming Parents for the First Time
The primary aim of this study is to test the effectiveness of the Becoming Parents Program--a couple focused educational program for couples having a first child--on individual and couple well being and the parent-infant relationship over the first three years of parenthood.
Other aims of this study are to evaluate the cost of implementing the Becoming Parents Program; to describe changes in individual and couple well-being over time, viewing the transition to parenthood from a developmental perspective using data from the control group; examine the various variables in the study over time from pregnancy through three years post-birth.
Study Overview
Detailed Description
The transition to parenthood is extremely difficult for both mothers and fathers, yet education and support during this major life transition emphasize getting through labor and birth, rather than preparing couples for the many changes accompanying parenthood. The classes of the Becoming Parents Program provide information and skills for taking care of the couple relationship, taking care of self, interacting with the baby, and the many ways becoming parents changes peoples' lives.
The purpose of this study is to evaluate the effects of the Becoming Parents Program classes on individual well being (measured by symptoms of depression and stress, perceived health, risk behaviors, health practices, health resource utilization), couple well-being (measured by marital satisfaction and stability), and the parent-infant relationship (measured by observation of the mother feeding the baby and the father teaching the baby) over the first three years of parenthood. Information is gathered by paper-and-pencil questionnaires during pregnancy, and at six months, one year, two years, and three years post-birth and by observation of parent-infant interaction at three months post-birth and videotaping and coding of couple interaction at six months post-birth.
Hypotheses are that couples who receive the Becoming Parents Program classes as compared to the couples who do not will:
- have higher levels of marital satisfaction
- have lower levels of depression
- have less symptoms of stress
- have higher levels of marital stability
- communicate more effectively about a problem issue
- have higher levels of health and well-being
- score higher on observational evaluations of parent-infant interaction
- report they are more satisfied with parenting, their partner's involvement in parenting their child, and with who does what in their family
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- married couples
- expecting the birth of a first child
- not more than 30 weeks pregnant
Exclusion Criteria:
- consider their couple relationship in immediate danger or breaking up
Study Plan
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 |
|---|---|
|
Active Comparator: 1
Subjects receiving the Becoming Parents Program
|
Couple focused educational program for couples adding a new baby to the family-21 hours of workshops during pregnancy with two three hour workshops after the baby is born.
|
|
Placebo Comparator: 2
Subjects not receiving the Becoming Parents Program
|
Couple focused educational program for couples adding a new baby to the family-21 hours of workshops during pregnancy with two three hour workshops after the baby is born.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Scores on a marital satisfaction scale at 6 months, 1 , 2 , 3 post-birth
Time Frame: 6 mos, 1 yr, 2 yrs, 3 yrs post-birth
|
6 mos, 1 yr, 2 yrs, 3 yrs post-birth
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Scores on a depression rating scale
Time Frame: 6 mos, 1 yr, 2 yrs, 3 yrs post-birth
|
6 mos, 1 yr, 2 yrs, 3 yrs post-birth
|
|
Scores on a symptoms of stress measure
Time Frame: 6 mos, 1 yr, 2 yrs, 3 yrs post-birth
|
6 mos, 1 yr, 2 yrs, 3 yrs post-birth
|
|
Whether or not subject couples are still married
Time Frame: 6 mos, 1 yr, 2 yrs, 3 yrs post-birth
|
6 mos, 1 yr, 2 yrs, 3 yrs post-birth
|
|
Coding of how effectively couples communicate about a problem issue in their relationship as observed from a videotape of the couples interacting at 6 months post-birth
Time Frame: 6 mos post-birth
|
6 mos post-birth
|
|
Individual participant ratings of their own health, their partner's health, their baby's health
Time Frame: 6 mos, 1 yr, 2 yrs, 3 yrs post-birth
|
6 mos, 1 yr, 2 yrs, 3 yrs post-birth
|
|
Identification of health risk behaviors and health practices
Time Frame: 6 mos, 1 yr, 2 yrs, 3 yrs post-birth
|
6 mos, 1 yr, 2 yrs, 3 yrs post-birth
|
|
Health resource utilization
Time Frame: 6 mos, 1 yr, 2 yrs, 3 yrs post-birth
|
6 mos, 1 yr, 2 yrs, 3 yrs post-birth
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Pamela L Jordan, PhD, Dept of Family & Child Nursing, University of Washington
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
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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