Infant Health Risk FactorsNCT01692288
Evaluation of the Effectiveness of a Home Visiting Program for New Parents in New Mexico
A study testing First Born® Program home visiting services in people with Infant Health Risk Factors, run by RAND at 1 site in United States.
Trial summary
The purpose of this study is to determine if children and mothers who participate in the First Born® Program (FBP) experience better outcomes than they would have in the absence of the program. The evaluation employs a randomized trial design to assess the effectiveness of the FBP in the Santa Fe County, NM, site. Read more about this study
- Who is it for?
- Ages Up to 2 months
- Conditions the study is for
- Infant Health Risk Factors
- What is being tested?
- First Born® Program home visiting services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Apr 2015
- 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 Up to 2 months
- All sexes
- Child
Who may be able to join
- First-time parent
- Mother is currently pregnant or child is less than two months old
- Lives within Santa Fe County, New Mexico
- Parent accepts referral to First Born Program
Who cannot join
- Child is not first born
- First-born child is two months or older
- Parent resides outside Santa Fe County
- Parent has not been referred to First Born Program
Trial locations and contacts
1 site in 1 country.
United States1 site
United Way of Santa Fe County First Born® Program
Santa Fe, New Mexico, 87501
About this study
Official title: Evaluation of the Effectiveness of the First Born® Program for New Parents in Santa Fe County, New Mexico
The purpose of this study is to determine if children and mothers who participate in the First Born® Program (FBP) experience better outcomes than they would have in the absence of the program. The evaluation employs a randomized trial design to assess the effectiveness of the FBP in the Santa Fe County, NM, site. FBP is a home visitation program that uses clinically trained professionals to provide first-time parents with information, training, and access to resources designed to promote early childhood development. Services are free and may begin at any time during pregnancy or up to two months after the baby's birth and may continue until the child is three years old. In addition, a nurse postpartum home visit is offered to the parents of all participating newborns. The FBP model builds on other home visiting and prevention programs that have been shown to improve long-term outcomes of children and their families.
- Conditions
- Infant Health Risk Factors
- Being tested
- First Born® Program home visiting services
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First Born® Program home visiting servicesBehavioural
Family and first-born child are offered and/or receive weekly First Born® Program home visiting services between pregnancy and the child's third birthday. Families are eligible to enroll in the program from pregnancy up to two months after birth.
| Study group | Role | What they receive |
|---|---|---|
| Offered First Born® Program services | Experimental | Family and first-born child are selected to be offered First Born® Program home visiting services. Receives: Behavioral: First Born® Program home visiting services |
| Not offered First Born® Program services | No intervention | Family and first-born child are not selected to be offered First Born® Program home visiting services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with child health or development risk factors
Measured: First year of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infant Health Risk FactorsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Kilburn, RAND
- Investigators
- Rebecca Kilburn, PhD, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692288
- Sponsor's protocol ID
- K7051-07-03
- Status last verified
- Jan 2017
- First submitted
- 14 Sep 2012
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Kilburn MR, Cannon JS. Home Visiting Start-Up: Lessons Learned From Program Replication in New Mexico. J Prim Prev. 2015 Aug;36(4):275-9. doi: 10.1007/s10935-015-0392-5.
PubMed 25921835Kilburn, M.R. Lessons from the randomized trial evaluation of a new parent program: when the evaluators see the glass as half full, and the community sees the glass as half empty. J Exp Criminol (2012) 8: 255. doi:10.1007/s11292-012-9152-1
Kilburn MR, Cannon JS. Home Visiting and Use of Infant Health Care: A Randomized Clinical Trial. Pediatrics. 2017 Jan;139(1):e20161274. doi: 10.1542/peds.2016-1274. Epub 2016 Dec 15.
PubMed 27980028
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of the First Born® Program for New Parents in Santa Fe County, New Mexico
- ClinicalTrials.gov ID
- NCT01692288
- Acronym / sponsor ID
- K7051-07-03
- Conditions
- Infant Health Risk Factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 25 Sep 2012 (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 purpose of this study is to determine if children and mothers who participate in the First Born® Program (FBP) experience better outcomes than they would have in the absence of the program. The evaluation employs a randomized trial design to assess the effectiveness of the FBP in the Santa Fe County, NM, site. FBP is a home visitation program that uses clinically trained professionals to provide first-time parents with information, training, and access to resources designed to promote early childhood development. Services are free and may begin at any time during pregnancy or up to two months after the baby's birth and may continue until the child is three years old. In addition, a nurse postpartum home visit is offered to the parents of all participating newborns. The FBP model builds on other home visiting and prevention programs that have been shown to improve long-term outcomes of children and their families.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Offered First Born® Program services | Experimental | Behavioral: First Born® Program home visiting servicesFamily and first-born child are selected to be offered First Born® Program home visiting services. |
| Not offered First Born® Program services | No intervention | –Family and first-born child are not selected to be offered First Born® Program home visiting services. |
Who may qualify
- Ages
- Up to 2 months
- Sex
- All
- Age groups
- Child
Key inclusion criteria (4 listed)
- First-time parent
- Mother is currently pregnant or child is less than two months old
- Lives within Santa Fe County, New Mexico
- Parent accepts referral to First Born Program
Key exclusion criteria (4 listed)
- Child is not first born
- First-born child is two months or older
- Parent resides outside Santa Fe County
- Parent has not been referred to First Born Program
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 |
|---|---|---|
| First Born® Program home visiting servicesFamily and first-born child are offered and/or receive weekly First Born® Program home visiting services between pregnancy and the child's third birthday. Families are eligible to enroll in the program from pregnancy up to two months after birth. | Behavioural | Offered First Born® Program services |
Primary outcome
Number of participants with child health or development risk factors
Time frame: First year of life
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 6 Jan 2017.
- Background: PubMed 25921835Kilburn MR, Cannon JS. Home Visiting Start-Up: Lessons Learned From Program Replication in New Mexico. J Prim Prev. 2015 Aug;36(4):275-9. doi: 10.1007/s10935-015-0392-5.
- BackgroundKilburn, M.R. Lessons from the randomized trial evaluation of a new parent program: when the evaluators see the glass as half full, and the community sees the glass as half empty. J Exp Criminol (2012) 8: 255. doi:10.1007/s11292-012-9152-1
- Results publication: PubMed 27980028Kilburn MR, Cannon JS. Home Visiting and Use of Infant Health Care: A Randomized Clinical Trial. Pediatrics. 2017 Jan;139(1):e20161274. doi: 10.1542/peds.2016-1274. Epub 2016 Dec 15.
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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.
Rebecca Kilburn, PhD principal investigator
RAND
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First Born® Program home visiting services in people with Infant Health Risk Factors, run by RAND at 1 site in United States.
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: finished, as of the sponsor's last update on 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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?
Number of participants with child health or development risk factors (time frame: First year of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01692288, which also lists 3 linked publications.
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 6 Jan 2017.