Age 9 Follow-up of Preventive Intervention (Denver) (DenverY09)
29 januari 2013 bijgewerkt door: University of Colorado, Denver
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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
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?
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?
Studietype
Ingrijpend
Inschrijving (Werkelijk)
584
Fase
- Niet toepasbaar
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Geen tussenkomst: Controlegroep
|
|
|
Experimenteel: Paraprofessional home visits
home visitation by Paraprofessional
|
Home visits from mid-pregnancy until child age 2. Group 2 is visits by a paraprofessional; group 3 is visits by nurses.
|
|
Experimenteel: Nurse home visits
home visitation by Nurse
|
Home visits from mid-pregnancy until child age 2. Group 2 is visits by a paraprofessional; group 3 is visits by nurses.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
fewer subsequent pregnancies
Tijdsspanne: When first child is 9
|
When first child is 9
|
|
increased interval between the birth of the first and second child
Tijdsspanne: When first child is 9
|
When first child is 9
|
|
reduced use of welfare
Tijdsspanne: When first child is 9
|
When first child is 9
|
|
increased participation in the work force
Tijdsspanne: When first child is 9
|
When first child is 9
|
|
reduced behavioral problems due to use of alcohol and drugs
Tijdsspanne: When first child is 9
|
When first child is 9
|
|
fewer arrests
Tijdsspanne: When first child is 9
|
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.
Tijdsspanne: When first child is 9
|
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.
Tijdsspanne: At child age 9
|
At child age 9
|
|
children's aggressive and destructive themes and narrative coherence in their responses to story stems.
Tijdsspanne: At child age 9
|
At child age 9
|
|
executive functions and school achievement.
Tijdsspanne: At child age 9
|
At child age 9
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 februari 2004
Studie voltooiing (Werkelijk)
1 april 2006
Studieregistratiedata
Eerst ingediend
20 februari 2007
Eerst ingediend dat voldeed aan de QC-criteria
21 februari 2007
Eerst geplaatst (Schatting)
22 februari 2007
Updates van studierecords
Laatste update geplaatst (Schatting)
31 januari 2013
Laatste update ingediend die voldeed aan QC-criteria
29 januari 2013
Laatst geverifieerd
1 januari 2013
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 03-0776
- R01MH069891 (Subsidie/contract van de Amerikaanse NIH)
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