Age 12 Follow-up of Early Preventive Intervention (Memphis)

Risk Reduction Behavior Clinical Trial

— MemphisY12  

Official title:

Age 12 Follow-up of Early Preventive Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00438165
• Other study ID #: 02-0683
• Secondary ID: R01MH068790
• Status: Completed
• Phase: N/A
• First received: February 20, 2007
• Last updated: February 18, 2016
• Start date: September 2003
• Est. completion date: May 2012

Study information

• Verified date: February 2016
• 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 nurses from child age 2 through 12.

Description:

This study is a longitudinal follow-up of 679 low-income women (89% African American) and their firstborn and subsequent children who have participated in a randomized trial of prenatal and infancy home visiting by nurses in Memphis, Tennessee since 1988. The study was conducted when the first-born children completed sixth grade, at around their 12th birthday.

The current follow-up was designed to determine whether: a) nurse-visited women differ from comparison group women in their life-course outcomes (the number and spacing of subsequent pregnancies and births; the rates of marriage and cohabitation with the father of the child; their employment, career growth, economic self-sufficiency, and welfare dependence; and behavioral problems due to substance abuse; arrests for serious misdemeanors and felonies); b) children of nurse-visited women differ from comparison-children in their academic achievement, placements in special education, rates of grade retention, conduct in school, and academic achievement; c) there are lower rates of developmental disability, grade retention, placement in special education, and school disciplinary actions among subsequent children born to nurse-visited women; d) nurse-visited families have fewer government expenditures and higher taxes paid; e) the effects of the program on child outcomes are concentrated on children born to women with low psychological resources; f) the effects of the program on maternal life course and government costs are concentrated on women with high psychological resources; g) the effects of the program on children are greater in schools and neighborhoods that contain greater risks for academic and behavioral problems; h) the effect of the program on children's disruptive behavior problems is explained by the combined effects of the program on maternal life-course, qualities of parental care-giving, and children's sequential processing skills, and aggressive and violent themes, reliance on adults, and story incoherence in their responses to the McArthur Story Stem Battery at earlier assessments. Data will be derived from maternal interviews and reviews of state administrative and school records. Results from this trial will provide policy makers with an estimate of likely long-term effects of this program when it is conducted in close to real-life conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 609
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Women <29 weeks gestation

• No previous live births

• At least 2 socio-demographic risk characteristics; e.g. unmarried, <12 years of education, unemployed.

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 visitation by nurses from midway through pregnancy until child age 12

Locations

Country	Name	City	State
United States	University of Rochester School of Nursing	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Kitzman H, Olds DL, Henderson CR Jr, Hanks C, Cole R, Tatelbaum R, McConnochie KM, Sidora K, Luckey DW, Shaver D, Engelhardt K, James D, Barnard K. Effect of prenatal and infancy home visitation by nurses on pregnancy outcomes, childhood injuries, and repeated childbearing. A randomized controlled trial. JAMA. 1997 Aug 27;278(8):644-52. — View Citation

Kitzman H, Olds DL, Sidora K, Henderson CR Jr, Hanks C, Cole R, Luckey DW, Bondy J, Cole K, Glazner J. Enduring effects of nurse home visitation on maternal life course: a 3-year follow-up of a randomized trial. JAMA. 2000 Apr 19;283(15):1983-9. — View Citation

Olds DL, Kitzman H, Cole R, Robinson J, Sidora K, Luckey DW, Henderson CR Jr, Hanks C, Bondy J, Holmberg J. Effects of nurse home-visiting on maternal life course and child development: age 6 follow-up results of a randomized trial. Pediatrics. 2004 Dec;114(6):1550-9. — View Citation

Olds DL, Kitzman H, Hanks C, Cole R, Anson E, Sidora-Arcoleo K, Luckey DW, Henderson CR Jr, Holmberg J, Tutt RA, Stevenson AJ, Bondy J. Effects of nurse home visiting on maternal and child functioning: age-9 follow-up of a randomized trial. Pediatrics. 2007 Oct;120(4):e832-45. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the number and spacing of subsequent pregnancies and births		When first child is 12	No
Primary	the rates of marriage and cohabitation with the father of the child		When first child is 12	No
Primary	mothers' employment, career growth, economic self-sufficiency, and welfare dependence		When first child is 12	No
Primary	mothers' behavioral problems due to substance abuse		When first child is 12	No
Primary	children's academic achievement, placements in special education, rates of grade retention, conduct in school, and academic achievement		At age 12	No
Primary	rates of developmental disability, grade retention, placement in special education, and school disciplinary actions among subsequent children		At age 12	No
Primary	mothers' arrests for serious misdemeanors and felonies		When first child is 12	No