Primary CareNCT00782028
Integrating Well-Woman and Well-Baby Care to Improve Parenting and Family Wellness
A study testing Centering parenting/Group well child care in people with Primary Care, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Trial summary
We hypothesize that relative to families who receive standard individual postpartum and pediatric care, families that receive group care will be more likely to have: Improved maternal and child health behaviors: i.e increased breastfeeding, exercise, child safety measures in the home and decreased smoking. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Primary Care
- What is being tested?
- Centering parenting/Group well child care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to May 2010
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Postpartum woman with baby in her care
- Receive well-woman care, well-child care and interviews in English
- Willingness to receive care in a group setting
- Woman planning to receive care at the Yale Women's Center for herself and the Primary Care Center for her baby
Who cannot join
- severe medical problem requiring individualized care for mother or baby
- Baby born at less than 37 weeks gestation
- Baby remaining in hospital when mother getting discharged for any other reason except hyperbilirubinemia
- Baby with severe cardiac, respiratory, neuro-developmental or surgical problems
About this study
We hypothesize that relative to families who receive standard individual postpartum and pediatric care, families that receive group care will be more likely to have:
- Improved maternal and child health behaviors: i.e increased breastfeeding, exercise, child safety measures in the home and decreased smoking.
- Better health care use for babies: i.e. attend more care visits, on-time and complete immunizations and decreased emergency services use.
- Better psychosocial outcomes for the families: i.e. decreased stress and depression, and increased social support.
- Improved parenting skills: i.e. improved knowledge of child development, involvement in developmentally appropriate activities, and parental sense of competence.
- Conditions
- Primary Care
- Being tested
- Centering parenting/Group well child care, Standard Care
- Keywords
- primary care, high-risk families, maternal depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Centering parenting/Group well child careOther
Intervention families will receive well child care in a group format for the first 12 month of the child's life.
Standard CareOther
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | No intervention consists of routine well child care Receives: Other: Standard Care |
| Centering parenting/Group well child care | Other | Not described Receives: Other: Centering parenting/Group well child care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved maternal and child health behaviors will be measured using a computer assisted interview.
Measured: Interviews will be given at 2 weeks, 6 and 12 months of age.
Secondary outcomes (3)
Better health care utilization for babies will be measured using Medical records review.
Measured: 1 year
Better psychosocial outcomes for mothers, fathers and babies will be measured using a computer assisted interview.
Measured: 2 weeks, 6 months and 12 months of age
Improved parenting skills will be assessed using a computer assisted inteview.
Measured: 2 weeks, 6 months ad 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionMay 2010 (estimated)
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary CareStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782028
- Sponsor's protocol ID
- R21 HDJ2810-01A1
- Status last verified
- Oct 2008
- First submitted
- 28 Oct 2008
- Last updated
- 29 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Well-Woman and Well-Baby Care to Improve Parenting and Family Wellness
- ClinicalTrials.gov ID
- NCT00782028
- Acronym / sponsor ID
- R21 HDJ2810-01A1
- Conditions
- Primary Care
- Keywords
- primary care, high-risk families, maternal depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Oct 2008
- Primary completion
- May 2010 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 29 Oct 2008 (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.
We hypothesize that relative to families who receive standard individual postpartum and pediatric care, families that receive group care will be more likely to have:
- Improved maternal and child health behaviors: i.e increased breastfeeding, exercise, child safety measures in the home and decreased smoking.
- Better health care use for babies: i.e. attend more care visits, on-time and complete immunizations and decreased emergency services use.
- Better psychosocial outcomes for the families: i.e. decreased stress and depression, and increased social support.
- Improved parenting skills: i.e. improved knowledge of child development, involvement in developmentally appropriate activities, and parental sense of competence.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | Other: Standard CareNo intervention consists of routine well child care |
| Centering parenting/Group well child care | Other | Other: Centering parenting/Group well child care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Postpartum woman with baby in her care
- Receive well-woman care, well-child care and interviews in English
- Willingness to receive care in a group setting
- Woman planning to receive care at the Yale Women's Center for herself and the Primary Care Center for her baby
Key exclusion criteria (4 listed)
- severe medical problem requiring individualized care for mother or baby
- Baby born at less than 37 weeks gestation
- Baby remaining in hospital when mother getting discharged for any other reason except hyperbilirubinemia
- Baby with severe cardiac, respiratory, neuro-developmental or surgical problems
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 |
|---|---|---|
| Centering parenting/Group well child careIntervention families will receive well child care in a group format for the first 12 month of the child's life. | Other | Centering parenting/Group well child care |
| Standard Care | Other | Standard Care |
Primary outcome
Improved maternal and child health behaviors will be measured using a computer assisted interview.
Time frame: Interviews will be given at 2 weeks, 6 and 12 months of age.
3 secondary outcomes
Better health care utilization for babies will be measured using Medical records review.
Time frame: 1 year
Better psychosocial outcomes for mothers, fathers and babies will be measured using a computer assisted interview.
Time frame: 2 weeks, 6 months and 12 months of age
Improved parenting skills will be assessed using a computer assisted inteview.
Time frame: 2 weeks, 6 months ad 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2008.
Related trials for Primary Care
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruiting
Impact of Pharmacotherapy Optimization in Polymedicated Lebanese Older Adults in Primary Health Care Centers
Older Adults (65 Years and Older), Polypharmacy (People Under Treatment With 5 or More Drugs)
RecruitingObservational study
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Age-related Macular Degeneration (AMD)
Recruiting
Technology-Based Intervention Pilot Testing
Dementia, Elder Abuse
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Centering parenting/Group well child care in people with Primary Care, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 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. 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?
Results are not available in the source record.
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?
Improved maternal and child health behaviors will be measured using a computer assisted interview. (time frame: Interviews will be given at 2 weeks, 6 and 12 months of age.). 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 29 Oct 2008.