Age 9 Follow-up of Preventive Intervention (Denver)

Risk Reduction Behavior Clinical Trial

— DenverY09  

Official title:

Age 9 Follow-up of Preventive Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00438594
• Other study ID #: 03-0776
• Secondary ID: R01MH069891
• Status: Completed
• Phase: N/A
• First received: February 20, 2007
• Last updated: January 29, 2013
• Start date: February 2004
• Est. completion date: April 2006

Study information

• Verified date: January 2013
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

To examine the impact of prenatal and infancy home visiting by paraprofessionals and by nurses from child age 2 through 9.

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:

1. 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?

2. 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?

3. To what extent are the benefits of the programs on mothers and children equivalent for Mexican- Americans and European-Americans?

4. 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?

6. 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 584
• Est. completion date: April 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Child Rearing
• Reproductive Behavior
• Risk Reduction Behavior

Intervention

Behavioral:
• home visitation
Home visits from mid-pregnancy until child age 2. Group 2 is visits by a paraprofessional; group 3 is visits by nurses.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Mental Health (NIMH), U.S. Department of Justice

References & Publications (2)

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. — View Citation

Olds 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fewer subsequent pregnancies		When first child is 9	No
Primary	increased interval between the birth of the first and second child		When first child is 9	No
Primary	reduced use of welfare		When first child is 9	No
Primary	increased participation in the work force		When first child is 9	No
Primary	reduced behavioral problems due to use of alcohol and drugs		When first child is 9	No
Primary	fewer arrests		When first child is 9	No
Primary	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.		When first child is 9	No
Primary	children's early-onset behavior problems (both externalizing and internalizing) reported by parents and teachers at home, at school, and with peers.		At child age 9	No
Primary	children's aggressive and destructive themes and narrative coherence in their responses to story stems.		At child age 9	No
Primary	executive functions and school achievement.		At child age 9	No