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Completed

NCT Number: NCT00438594

Age 9 Follow-up of Preventive Intervention (Denver)

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

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Key information

Conditions

Child Rearing Behavior Reproductive Behavior Risk Reduction Behavior

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

home visitation

Behavioral

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

Primary outcomes

  1. fewer subsequent pregnancies

    Time frame: When first child is 9

  2. increased interval between the birth of the first and second child

    Time frame: When first child is 9

  3. reduced use of welfare

    Time frame: When first child is 9

  4. increased participation in the work force

    Time frame: When first child is 9

  5. reduced behavioral problems due to use of alcohol and drugs

    Time frame: When first child is 9

  6. fewer arrests

    Time frame: When first child is 9

  7. 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

  8. 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

  9. children's aggressive and destructive themes and narrative coherence in their responses to story stems.

    Time frame: At child age 9

  10. executive functions and school achievement.

    Time frame: At child age 9

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • U.S. Department of Justice

Registry information

Official study title

Age 9 Follow-up of Preventive Intervention

Acronym: DenverY09

Important dates

Study start
2004
Study completion
2006
First posted
Feb 22, 2007
Registry last updated
Jan 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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