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Age 9 Follow-up of Preventive Intervention (Denver) (DenverY09)

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Completed

Conditions

Risk Reduction Behavior
Child Rearing
Reproductive Behavior

Treatments

Behavioral: home visitation

Study type

Interventional

Funder types

Other
Other U.S. Federal agency
NIH

Identifiers

NCT00438594
R01MH069891 (U.S. NIH Grant/Contract)
03-0776

Details and patient eligibility

About

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

Full 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?

  5. 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?

Enrollment

584 patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

584 participants in 3 patient groups

Control group
No Intervention group
Description:
Control group
Paraprofessional home visits
Experimental group
Description:
home visitation by Paraprofessional
Treatment:
Behavioral: home visitation
Nurse home visits
Experimental group
Description:
home visitation by Nurse
Treatment:
Behavioral: home visitation

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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