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

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.

Study Overview

• Status: Completed
• Conditions: Risk Reduction Behavior; Reproductive Behavior; Child Rearing
• Intervention / Treatment: Behavioral: home visitation

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:

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?

• Study Type: Interventional
• Enrollment (Actual): 584
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Paraprofessional home visits; home visitation by Paraprofessional	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.
Experimental: Nurse home visits; home visitation by Nurse	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
fewer subsequent pregnancies	When first child is 9
increased interval between the birth of the first and second child	When first child is 9
reduced use of welfare	When first child is 9
increased participation in the work force	When first child is 9
reduced behavioral problems due to use of alcohol and drugs	When first child is 9
fewer arrests	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.	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.	At child age 9
children's aggressive and destructive themes and narrative coherence in their responses to story stems.	At child age 9
executive functions and school achievement.	At child age 9

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute of Mental Health (NIMH); U.S. Department of Justice

Publications and helpful links

General Publications

• 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. doi: 10.1542/peds.2004-0961.
• 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.
• Olds 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Study Completion (Actual): April 1, 2006

Study Registration Dates

• First Submitted: February 20, 2007
• First Submitted That Met QC Criteria: February 21, 2007
• First Posted (Estimate): February 22, 2007

Study Record Updates

• Last Update Posted (Estimate): January 31, 2013
• Last Update Submitted That Met QC Criteria: January 29, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: pregnancy; nurse; child development; home visits; welfare; paraprofessional
• Other Study ID Numbers: 03-0776; R01MH069891 (U.S. NIH Grant/Contract)