Evaluation of the Efficacy of the Becoming Parents Program
| Tracking Information | |||||
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| First Received Date ICMJE | October 21, 2005 | ||||
| Last Updated Date | October 13, 2008 | ||||
| Start Date ICMJE | February 2002 | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE |
- scores on a marital satisfaction scale at 6 months, 1 , 2 , 3 postbirth | ||||
| Change History | Complete list of historical versions of study NCT00243997 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluation of the Efficacy of the Becoming Parents Program | ||||
| Official Title ICMJE | Study of the Effects of the Becoming Parents Program on Couples Becoming Parents for the First Time | ||||
| Brief Summary | 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. |
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| 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:
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Pregnancy | ||||
| Intervention ICMJE | 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. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 940 | ||||
| Completion Date | May 2008 | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00243997 | ||||
| Other Study ID Numbers ICMJE | 96-2009-C14, R01 NR004912 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Pamela Jordan/Principal Investigator, University of Washington | ||||
| Study Sponsor ICMJE | University of Washington | ||||
| Collaborators ICMJE | National Institute of Nursing Research (NINR) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Washington | ||||
| Verification Date | October 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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