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Follow-up Evaluation of Home Nurse Visitation Program for Socially Disadvantaged Women and Their Children

8. juni 2021 opdateret af: University of Colorado, Denver

Age-27 Follow-up of Early Preventive Intervention

This study will evaluate the long-term effects of a prenatal and early childhood home nurse visitation program for socially disadvantaged women and their children.

Studieoversigt

Detaljeret beskrivelse

Nearly half a million children are born each year to single, low-income mothers. Children born to socially disadvantaged mothers are more likely to experience chronic health problems, encounter child abuse and neglect, and receive insufficient health care. Home visitation by nurses during pregnancy and early childhood may prevent a wide range of health and developmental problems in children born to women who are either teenagers, unmarried, or of low economic status.

This study is associated with a home nurse visitation program that first began with 400 socially disadvantaged pregnant women between the years of 1977 and 1980 in an upstate New York semi-rural county. Participants in the original study were randomly assigned to participate in the home nurse visitation program or receive comparison services from pregnancy until the child's second birthday. Participants assigned to receive comparison services were provided with free transportation for prenatal and child care, as well as sensory and developmental screening for the child. Participants assigned to the home nurse visitation program were visited at home by a nurse 9 times during pregnancy and 23 times during the child's first 2 years of life. A follow-up study concluded that the home nurse visitation program reduced the number subsequent pregnancies, use of welfare, child abuse and neglect, and criminal behavior on the part of the socially disadvantaged mothers for up to 15 years after the birth of their first child.

This follow-up study will determine whether a home nurse visitation program has continued long-term effects on a child's health and development, 27 years later. Specifically, this study will evaluate whether the nurse-visited young adult offspring differ from the comparison group in their economic productivity; rates of child abuse and neglect; criminal behavior; mental health; abuse of substances; use of welfare, foster care, and healthcare in relation to government expenditures; and quality of their partnered relationships. Participants within the nurse-visited program group will be compared with each other to determine whether certain characteristics or factors, such as genetic vulnerabilities, environmental risks, or a history of child abuse, make someone less likely to benefit from a home nurse visitation program.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

345

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • New York
      • Elmira, New York, Forenede Stater, 14901
        • Comprehensive Interdisciplinary Development Services (CIDS)

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

27 år til 35 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Offspring of mothers who had participated in Elmira, N.Y. randomized clinical trial of prenatal and infant/toddler home visiting by nurses.
  • Participants needed to be at least 27 years of age.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Udviklingsscreening
Deltagerne modtog sensorisk og udviklingsmæssig screening og henvisning til yderligere evaluering og behandling af formodede problemer ved 12 og 24 måneders alderen.
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at ages 12 and 24 months of age
Aktiv komparator: Screening plus transport
Deltagerne modtog sensorisk og udviklingsmæssig screening og henvisning til yderligere evaluering og behandling af formodede problemer ved 12 og 24 måneders alderen; deres mødre modtog gratis transport til regelmæssig prænatal og velplejet børnepasning (op til barnet i alderen to).
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at ages 12 and 24 months of age
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2.
Aktiv komparator: Screening, transport, prænatale besøg
Deltagerne modtog sensorisk og udviklingsmæssig screening og henvisning til yderligere evaluering og behandling af formodede problemer ved 12 og 24 måneders alderen; deres mødre modtog gratis transport til regelmæssig prænatal og velplejet børnepasning (op til barnet i alderen to), plus sygeplejerskehjemmebesøg under graviditeten.
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at ages 12 and 24 months of age
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2.
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2, and were provided an average of 9 home visits by nurses during pregnancy.
Eksperimentel: Skærm, Transport, Prænatale/Inf besøg
Deltagerne modtog regelmæssig sensorisk og udviklingsmæssig screening og henvisning til yderligere evaluering og behandling af formodede problemer ved 12 og 24 måneders alderen; deres mødre modtog gratis transport til regelmæssig prænatal og velplejet børnepasning (op til børn i 2-års alderen), plus besøg af sygeplejerske under graviditeten og gennem barnet i 2-års alderen.
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at ages 12 and 24 months of age
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2.
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2, and were provided an average of 9 home visits by nurses during pregnancy.
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2, and were provided an average of 9 home visits by nurses during pregnancy and 23 during the child's first two years of life.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Economic productivity (e.g., unemployment, employment in jobs with limited opportunities for career growth, use of welfare, rates of out-of-wedlock births)
Tidsramme: Measured when child turns 27 years old
Measured when child turns 27 years old
Quality of partnered relationships (violence, commitment, and communication)
Tidsramme: Measured when child turns 27 years old
Measured when child turns 27 years old
Rates of child abuse and neglect
Tidsramme: Measured when child turns 27 years old
Measured when child turns 27 years old
Rates of criminal behavior, arrests, convictions, and imprisonment
Tidsramme: Measured when child turns 27 years old
Measured when child turns 27 years old
Mental health and abuse of substances
Tidsramme: Measured when child turns 27 years old
Measured when child turns 27 years old
Government expenditures and higher tax revenues
Tidsramme: Measured when child turns 27 years old
Measured when child turns 27 years old

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: David L. Olds, PhD, University of Colorado, Denver
  • Studieleder: John Eckenrode, PhD, Cornell University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2004

Primær færdiggørelse (Forventet)

1. december 2021

Studieafslutning (Forventet)

1. december 2021

Datoer for studieregistrering

Først indsendt

2. marts 2007

Først indsendt, der opfyldte QC-kriterier

5. marts 2007

Først opslået (Skøn)

6. marts 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juni 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2021

Sidst verificeret

1. juni 2021

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 04-0002
  • DSIR 84-CTP (NIH)
  • R01MH070761 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

We plan to share individual participant data once the primary reports on this phase of the trial are published. This includes baseline data on maternal characteristics at registration during pregnancy and outcome data on primary outcomes for offspring participants at the 27-year follow-up. Data will be made available through the University of Michigan Inter-University Consortium for Political and Social Research (ICPSR). We anticipate archiving the data from this study with ICPSR by March 2018

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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