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

29. januar 2013 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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?

Studietype

Intervensjonell

Registrering (Faktiske)

584

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Kontrollgruppe
Eksperimentell: Paraprofessional home visits
home visitation by Paraprofessional
Atferdsmessig: home visitation
Home visits from mid-pregnancy until child age 2. Group 2 is visits by a paraprofessional; group 3 is visits by nurses.
Eksperimentell: Nurse home visits
home visitation by Nurse
Atferdsmessig: home visitation
Home visits from mid-pregnancy until child age 2. Group 2 is visits by a paraprofessional; group 3 is visits by nurses.

Hva måler studien?

Primære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Colorado, Denver

Samarbeidspartnere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2004

Studiet fullført (Faktiske)

1. april 2006

Datoer for studieregistrering

Først innsendt

20. februar 2007

Først innsendt som oppfylte QC-kriteriene

21. februar 2007

Først lagt ut (Anslag)

22. februar 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

31. januar 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. januar 2013

Sist bekreftet

1. januar 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 03-0776
  • R01MH069891 (U.S. NIH-stipend/kontrakt)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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