Pregnancy Clinical Trial
Official title:
Study of the Effects of the Becoming Parents Program on Couples Becoming Parents for the First Time
Verified date | October 2008 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 940 |
Est. completion date | May 2008 |
Est. primary completion date | May 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Washington | National Institute of Nursing Research (NINR) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Scores on a marital satisfaction scale at 6 months, 1 , 2 , 3 post-birth | 6 mos, 1 yr, 2 yrs, 3 yrs post-birth | No | |
Secondary | Scores on a depression rating scale | 6 mos, 1 yr, 2 yrs, 3 yrs post-birth | No | |
Secondary | Scores on a symptoms of stress measure | 6 mos, 1 yr, 2 yrs, 3 yrs post-birth | No | |
Secondary | Whether or not subject couples are still married | 6 mos, 1 yr, 2 yrs, 3 yrs post-birth | No | |
Secondary | 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 | 6 mos post-birth | No | |
Secondary | Individual participant ratings of their own health, their partner's health, their baby's health | 6 mos, 1 yr, 2 yrs, 3 yrs post-birth | No | |
Secondary | Identification of health risk behaviors and health practices | 6 mos, 1 yr, 2 yrs, 3 yrs post-birth | No | |
Secondary | Health resource utilization | 6 mos, 1 yr, 2 yrs, 3 yrs post-birth | No |
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