PregnancyNCT00243997
Evaluation of the Efficacy of the Becoming Parents Program
A study testing Becoming Parents Program in people with Pregnancy, run by University of Washington.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Becoming Parents Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 940 participants
- Where
- No sites listed yet
- Study dates
- Feb 2002to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- married couples
- expecting the birth of a first child
- not more than 30 weeks pregnant
Who cannot join
- consider their couple relationship in immediate danger or breaking up
About this study
Official title: 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.
Read the 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
- Conditions
- Pregnancy
- Being tested
- Becoming Parents Program
- Keywords
- parents, fathers, mothers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Becoming Parents ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Subjects receiving the Becoming Parents Program Receives: Behavioral: Becoming Parents Program |
| 2 | Placebo comparator | Subjects not receiving the Becoming Parents Program Receives: Behavioral: Becoming Parents Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on a marital satisfaction scale at 6 months, 1 , 2 , 3 post-birth
Measured: 6 mos, 1 yr, 2 yrs, 3 yrs post-birth
Secondary outcomes (7)
Scores on a depression rating scale
Measured: 6 mos, 1 yr, 2 yrs, 3 yrs post-birth
Scores on a symptoms of stress measure
Measured: 6 mos, 1 yr, 2 yrs, 3 yrs post-birth
Whether or not subject couples are still married
Measured: 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
Measured: 6 mos post-birth
Individual participant ratings of their own health, their partner's health, their baby's health
Measured: 6 mos, 1 yr, 2 yrs, 3 yrs post-birth
Identification of health risk behaviors and health practices
Measured: 6 mos, 1 yr, 2 yrs, 3 yrs post-birth
Health resource utilization
Measured: 6 mos, 1 yr, 2 yrs, 3 yrs post-birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2005 (estimated)
- Study startFeb 2002
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 940 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Investigators
- Pamela L Jordan, PhD, Principal investigator, Dept of Family & Child Nursing, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00243997
- Sponsor's protocol ID
- 96-2009-C14
- Other IDs
- R01NR004912
- Status last verified
- Oct 2008
- First submitted
- 21 Oct 2005
- Last updated
- 15 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of the Becoming Parents Program on Couples Becoming Parents for the First Time
- ClinicalTrials.gov ID
- NCT00243997
- Acronym / sponsor ID
- 96-2009-C14
- Conditions
- Pregnancy
- Keywords
- parents, fathers, mothers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 940 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Feb 2002
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 25 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Becoming Parents ProgramSubjects receiving the Becoming Parents Program |
| 2 | Placebo comparator | Behavioral: Becoming Parents ProgramSubjects not receiving the Becoming Parents Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- married couples
- expecting the birth of a first child
- not more than 30 weeks pregnant
Key exclusion criteria (1 listed)
- consider their couple relationship in immediate danger or breaking up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Becoming Parents ProgramCouple 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. | Behavioural | 1, 2 |
Primary outcome
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
7 secondary outcomes
Scores on a depression rating scale
Time frame: 6 mos, 1 yr, 2 yrs, 3 yrs post-birth
Scores on a symptoms of stress measure
Time frame: 6 mos, 1 yr, 2 yrs, 3 yrs post-birth
Whether or not subject couples are still married
Time frame: 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
Time frame: 6 mos post-birth
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
Identification of health risk behaviors and health practices
Time frame: 6 mos, 1 yr, 2 yrs, 3 yrs post-birth
Health resource utilization
Time frame: 6 mos, 1 yr, 2 yrs, 3 yrs post-birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela L Jordan, PhD principal investigator
Dept of Family & Child Nursing, University of Washington
Questions about this trial
What is this clinical trial studying?
A study testing Becoming Parents Program in people with Pregnancy, run by University of Washington.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2008.