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Evaluation of the Efficacy of the Becoming Parents Program

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00243997
First received: October 21, 2005
Last updated: October 13, 2008
Last verified: October 2008

October 21, 2005
October 13, 2008
February 2002
May 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
- scores on a marital satisfaction scale at 6 months, 1 , 2 , 3 postbirth
Complete list of historical versions of study NCT00243997 on ClinicalTrials.gov Archive Site
  • Scores on a depression rating scale [ Time Frame: 6 mos, 1 yr, 2 yrs, 3 yrs post-birth ] [ Designated as safety issue: No ]
  • Scores on a symptoms of stress measure [ Time Frame: 6 mos, 1 yr, 2 yrs, 3 yrs post-birth ] [ Designated as safety issue: No ]
  • Whether or not subject couples are still married [ Time Frame: 6 mos, 1 yr, 2 yrs, 3 yrs post-birth ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Identification of health risk behaviors and health practices [ Time Frame: 6 mos, 1 yr, 2 yrs, 3 yrs post-birth ] [ Designated as safety issue: No ]
  • Health resource utilization [ Time Frame: 6 mos, 1 yr, 2 yrs, 3 yrs post-birth ] [ Designated as safety issue: No ]
  • - scores on a depression rating scale
  • - scores on a symptoms of stress measure
  • - whether or not subject couples are still married
  • - 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 postbirth
  • - individual participant ratings of their own health, their partner's health, their baby's health;
  • - identification of health risk behaviors and health practices;
  • - health resource utilization
Not Provided
Not Provided
 
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.

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Pregnancy
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.
  • Active Comparator: 1
    Subjects receiving the Becoming Parents Program
    Intervention: Behavioral: Becoming Parents Program
  • Placebo Comparator: 2
    Subjects not receiving the Becoming Parents Program
    Intervention: Behavioral: Becoming Parents Program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
940
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00243997
96-2009-C14, R01 NR004912
Yes
Pamela Jordan/Principal Investigator, University of Washington
University of Washington
National Institute of Nursing Research (NINR)
Principal Investigator: Pamela L Jordan, PhD Dept of Family & Child Nursing, University of Washington
University of Washington
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP