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Evaluation of the Efficacy of the Becoming Parents Program

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00243997
First Posted: October 25, 2005
Last Update Posted: October 15, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by:
University of Washington
  Purpose

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.


Condition Intervention
Pregnancy Behavioral: Becoming Parents Program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Study of the Effects of the Becoming Parents Program on Couples Becoming Parents for the First Time

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Scores on a depression rating scale [ Time Frame: 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 ]
  • Whether or not subject couples are still married [ Time Frame: 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 ]
  • 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 ]
  • Identification of health risk behaviors and health practices [ Time Frame: 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 ]

Enrollment: 940
Study Start Date: February 2002
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Subjects receiving the Becoming Parents Program
Behavioral: 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
Behavioral: 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.

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:

  1. have higher levels of marital satisfaction
  2. have lower levels of depression
  3. have less symptoms of stress
  4. have higher levels of marital stability
  5. communicate more effectively about a problem issue
  6. have higher levels of health and well-being
  7. score higher on observational evaluations of parent-infant interaction
  8. report they are more satisfied with parenting, their partner's involvement in parenting their child, and with who does what in their family
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00243997


Sponsors and Collaborators
University of Washington
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Pamela L Jordan, PhD Dept of Family & Child Nursing, University of Washington
  More Information

Responsible Party: Pamela Jordan/Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT00243997     History of Changes
Other Study ID Numbers: 96-2009-C14
R01NR004912 ( U.S. NIH Grant/Contract )
First Submitted: October 21, 2005
First Posted: October 25, 2005
Last Update Posted: October 15, 2008
Last Verified: October 2008

Keywords provided by University of Washington:
parents
fathers
mothers