Child RearingDenverY09NCT00438594
Age 9 Follow-up of Preventive Intervention (Denver)
A study testing home visitation in people with Child Rearing and Risk Reduction Behavior, run by University of Colorado, Denver.
Trial summary
To examine the impact of prenatal and infancy home visiting by paraprofessionals and by nurses from child age 2 through 9. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Child Rearing, Risk Reduction Behavior, Reproductive Behavior
- What is being tested?
- home visitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 584 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Apr 2006
- 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
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women from 21 antepartum clinics serving low-income women in Denver recruited if they had no previous live births and either qualified for Medicaid or had no private insurance.
Who cannot join
None listed.
About this study
Official title: Age 9 Follow-up of Preventive Intervention
To examine the impact of prenatal and infancy home visiting by paraprofessionals and by nurses from child age 2 through 9.
Read the detailed description
This project supports a 9-year follow-up of 650 children and their families who were enrolled in a randomized trial of prenatal and infancy home visiting by paraprofessionals and by nurses; participating families were assigned to control, paraprofessional-, or nurse-visited conditions. Earlier phases of assessment found significant benefits for nurse- and paraprofessional-visited families and children, although the nurse effects tended to be larger. The current phase of follow-up is designed to determine whether the effects of the nurse and paraprofessional programs endure and grow through the child age 9.5.
The project is organized around seven questions:
- Do the programs of nurse and paraprofessional home-visiting produce enduring effects on: a) mothers' life-course; b) qualities of care parents provide to their children; c) children's early-onset behavior problems; d) children's incoherence and aggression/destruction in response to story stems; e) children's executive, language, and intellectual functioning and school achievement?
- To what extent are the beneficial effects of the programs on parental care-giving and children's development concentrated on those born to mothers with few psychological resources?
- To what extent are the benefits of the programs on mothers and children equivalent for Mexican- Americans and European-Americans?
- To what extent are the effects of the programs on antisocial behavior concentrated on boys? 5. To what extent are program effects moderated by school and neighborhood contexts?
- To what extent are the effects of the programs on children's development explained by impacts of the programs on women's prenatal smoking, maternal life-course, qualities of parental caregiving, and children's earlier language development, executive functioning, and emotional regulation? 7. To what extent are the initial costs of the programs recovered in reduced expenditures for other government services during the first nine years of the first child's life?
- Being tested
- home visitation
- Keywords
- nurse, paraprofessional, home visits, pregnancy, welfare, child development
- Medical subject headings
- Risk Reduction Behavior, Reproductive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home visitationBehavioural
Home visits from mid-pregnancy until child age 2. Group 2 is visits by a paraprofessional; group 3 is visits by nurses.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Control group |
| Paraprofessional home visits | Experimental | home visitation by Paraprofessional Receives: Behavioral: home visitation |
| Nurse home visits | Experimental | home visitation by Nurse Receives: Behavioral: home visitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
fewer subsequent pregnancies
Measured: When first child is 9
increased interval between the birth of the first and second child
Measured: When first child is 9
reduced use of welfare
Measured: When first child is 9
increased participation in the work force
Measured: When first child is 9
reduced behavioral problems due to use of alcohol and drugs
Measured: When first child is 9
fewer arrests
Measured: When first child is 9
increased qualities of care parents provide to their children as reflected in fewer verified reports of child abuse and neglect and observations of coercive mother-child interaction.
Measured: When first child is 9
children's early-onset behavior problems (both externalizing and internalizing) reported by parents and teachers at home, at school, and with peers.
Measured: At child age 9
children's aggressive and destructive themes and narrative coherence in their responses to story stems.
Measured: At child age 9
executive functions and school achievement.
Measured: At child age 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2007 (estimated)
- Study startFeb 2004
- Study completionApr 2006
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 Child RearingStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 584 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Justice, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- David L Olds, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00438594
- Sponsor's protocol ID
- 03-0776
- Other IDs
- R01MH069891
- Acronym
- DenverY09
- Status last verified
- Jan 2013
- First submitted
- 20 Feb 2007
- Last updated
- 31 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Olds DL, Robinson J, O'Brien R, Luckey DW, Pettitt LM, Henderson CR Jr, Ng RK, Sheff KL, Korfmacher J, Hiatt S, Talmi A. Home visiting by paraprofessionals and by nurses: a randomized, controlled trial. Pediatrics. 2002 Sep;110(3):486-96. doi: 10.1542/peds.110.3.486.
PubMed 12205249Olds DL, Robinson J, Pettitt L, Luckey DW, Holmberg J, Ng RK, Isacks K, Sheff K, Henderson CR Jr. Effects of home visits by paraprofessionals and by nurses: age 4 follow-up results of a randomized trial. Pediatrics. 2004 Dec;114(6):1560-8. doi: 10.1542/peds.2004-0961.
PubMed 15574615Olds DL, Holmberg JR, Donelan-McCall N, Luckey DW, Knudtson MD, Robinson J. Effects of home visits by paraprofessionals and by nurses on children: follow-up of a randomized trial at ages 6 and 9 years. JAMA Pediatr. 2014 Feb;168(2):114-21. doi: 10.1001/jamapediatrics.2013.3817.
PubMed 24296904
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age 9 Follow-up of Preventive Intervention
- ClinicalTrials.gov ID
- NCT00438594
- Acronym / sponsor ID
- DenverY09 / 03-0776
- Keywords
- nurse, paraprofessional, home visits, pregnancy, welfare, child development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 584 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- U.S. Department of Justice, National Institute of Mental Health (NIMH)
- Study start
- Feb 2004
- Study completion
- Apr 2006 (actual)
- First posted
- 22 Feb 2007 (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.
To examine the impact of prenatal and infancy home visiting by paraprofessionals and by nurses from child age 2 through 9.
Detailed description
This project supports a 9-year follow-up of 650 children and their families who were enrolled in a randomized trial of prenatal and infancy home visiting by paraprofessionals and by nurses; participating families were assigned to control, paraprofessional-, or nurse-visited conditions. Earlier phases of assessment found significant benefits for nurse- and paraprofessional-visited families and children, although the nurse effects tended to be larger. The current phase of follow-up is designed to determine whether the effects of the nurse and paraprofessional programs endure and grow through the child age 9.5.
The project is organized around seven questions:
- Do the programs of nurse and paraprofessional home-visiting produce enduring effects on: a) mothers' life-course; b) qualities of care parents provide to their children; c) children's early-onset behavior problems; d) children's incoherence and aggression/destruction in response to story stems; e) children's executive, language, and intellectual functioning and school achievement?
- To what extent are the beneficial effects of the programs on parental care-giving and children's development concentrated on those born to mothers with few psychological resources?
- To what extent are the benefits of the programs on mothers and children equivalent for Mexican- Americans and European-Americans?
- To what extent are the effects of the programs on antisocial behavior concentrated on boys? 5. To what extent are program effects moderated by school and neighborhood contexts?
- To what extent are the effects of the programs on children's development explained by impacts of the programs on women's prenatal smoking, maternal life-course, qualities of parental caregiving, and children's earlier language development, executive functioning, and emotional regulation? 7. To what extent are the initial costs of the programs recovered in reduced expenditures for other government services during the first nine years of the first child's life?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Control group |
| Paraprofessional home visits | Experimental | Behavioral: home visitationhome visitation by Paraprofessional |
| Nurse home visits | Experimental | Behavioral: home visitationhome visitation by Nurse |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women from 21 antepartum clinics serving low-income women in Denver recruited if they had no previous live births and either qualified for Medicaid or had no private insurance.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| home visitationHome visits from mid-pregnancy until child age 2. Group 2 is visits by a paraprofessional; group 3 is visits by nurses. | Behavioural | Nurse home visits, Paraprofessional home visits |
Primary outcome
fewer subsequent pregnancies
Time frame: When first child is 9
increased interval between the birth of the first and second child
Time frame: When first child is 9
reduced use of welfare
Time frame: When first child is 9
increased participation in the work force
Time frame: When first child is 9
reduced behavioral problems due to use of alcohol and drugs
Time frame: When first child is 9
fewer arrests
Time frame: When first child is 9
increased qualities of care parents provide to their children as reflected in fewer verified reports of child abuse and neglect and observations of coercive mother-child interaction.
Time frame: When first child is 9
children's early-onset behavior problems (both externalizing and internalizing) reported by parents and teachers at home, at school, and with peers.
Time frame: At child age 9
children's aggressive and destructive themes and narrative coherence in their responses to story stems.
Time frame: At child age 9
executive functions and school achievement.
Time frame: At child age 9
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 31 Jan 2013.
- Background: PubMed 12205249Olds DL, Robinson J, O'Brien R, Luckey DW, Pettitt LM, Henderson CR Jr, Ng RK, Sheff KL, Korfmacher J, Hiatt S, Talmi A. Home visiting by paraprofessionals and by nurses: a randomized, controlled trial. Pediatrics. 2002 Sep;110(3):486-96. doi: 10.1542/peds.110.3.486.
- Background: PubMed 15574615Olds DL, Robinson J, Pettitt L, Luckey DW, Holmberg J, Ng RK, Isacks K, Sheff K, Henderson CR Jr. Effects of home visits by paraprofessionals and by nurses: age 4 follow-up results of a randomized trial. Pediatrics. 2004 Dec;114(6):1560-8. doi: 10.1542/peds.2004-0961.
- Derived from this study: PubMed 24296904Olds DL, Holmberg JR, Donelan-McCall N, Luckey DW, Knudtson MD, Robinson J. Effects of home visits by paraprofessionals and by nurses on children: follow-up of a randomized trial at ages 6 and 9 years. JAMA Pediatr. 2014 Feb;168(2):114-21. doi: 10.1001/jamapediatrics.2013.3817.
Related trials for Child Rearing
Active, not recruiting
Women Supporting Women to Improve Infant and Child Feeding Practices
Undernutrition, Healthy Nutrition
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.
David L Olds, PhD principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
A study testing home visitation in people with Child Rearing and Risk Reduction Behavior, run by University of Colorado, Denver.
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 1 inclusion and 0 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 31 Jan 2013. 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?
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?
fewer subsequent pregnancies (time frame: When first child is 9). The study lists 10 primary outcomes in all. 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 NCT00438594, 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 31 Jan 2013.