Evaluation of the Efficacy of the Becoming Parents Program | NCT00243997

Studies
Evaluation of the Efficacy of the Becoming Parents Program

NCT00243997

Sponsor

University of Washington

Status

Completed

Last Update Posted

Oct 15, 2008Estimated

Enrollment

940Actual

Phase

Not Applicable

Conditions

Pregnancy

Interventions

Becoming Parents Program

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01NR004912	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2002

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Oct 21, 2005

First Submission Date that Met QC Criteria

Oct 21, 2005

First Posted Date

Oct 25, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2008

Last Update Posted Date

Oct 15, 2008Estimated

Name	Class
National Institute of Nursing Research (NINR)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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:

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

940Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Becoming Parents Program	Behavioral	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pamela L Jordan, PhD	Dept of Family & Child Nursing, University of Washington	Principal Investigator

Locations

Not provided