NCT00243997

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
940

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Feb 2002

Longer than P75 for not_applicable pregnancy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 25, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

October 15, 2008

Status Verified

October 1, 2008

Enrollment Period

6.2 years

First QC Date

October 21, 2005

Last Update Submit

October 13, 2008

Conditions

Keywords

parentsfathersmothers

Outcome Measures

Primary Outcomes (1)

  • Scores on a marital satisfaction scale at 6 months, 1 , 2 , 3 post-birth

    6 mos, 1 yr, 2 yrs, 3 yrs post-birth

Secondary Outcomes (7)

  • Scores on a depression rating scale

    6 mos, 1 yr, 2 yrs, 3 yrs post-birth

  • Scores on a symptoms of stress measure

    6 mos, 1 yr, 2 yrs, 3 yrs post-birth

  • Whether or not subject couples are still married

    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

    6 mos post-birth

  • 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

  • +2 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Subjects receiving the Becoming Parents Program

Behavioral: Becoming Parents Program

2

PLACEBO COMPARATOR

Subjects not receiving the Becoming Parents Program

Behavioral: Becoming Parents Program

Interventions

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.

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • married couples
  • expecting the birth of a first child
  • not more than 30 weeks pregnant

You may not qualify if:

  • consider their couple relationship in immediate danger or breaking up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Pamela L Jordan, PhD

    Dept of Family & Child Nursing, University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 21, 2005

First Posted

October 25, 2005

Study Start

February 1, 2002

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

October 15, 2008

Record last verified: 2008-10