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Social Circumstances, Parenting Techniques, and Infant Development

27. januar 2020 opdateret af: Catherine Monk, New York State Psychiatric Institute

  1. Investigators aim to assess a novel behavioral intervention (currently approved in Protocol #6285) behavioral intervention that promotes maternally-mediated behavioral changes in young infants to reduce the risk of postpartum depression in a group of low income women. More specifically, investigators aim to determine if a behavioral intervention targeting maternal caregiving of young infants can increase infant sleep and reduce fuss/cry behavior and thereby: (1) reduce the incidence and/or severity of postpartum maternal depression in low socioeconomic status (SES) women, and (2) improve the quality of mother-infant interaction and subsequent child development. Investigators will study:

    1. The feasibility of applying this protocol with a low SES population
    2. The effectiveness of the intervention compared to usual care
    3. If the effects of the intervention can be detected in assessments of the quality of mother-infant interaction and infant neurocognitive development
  2. Investigators aim to determine whether this behavioral intervention can affect infant development as measured by neurodevelopmental assessments and cortisol reactivity at 4 months of age.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Developmental research consistently shows that postpartum depression has a negative impact on cognitive and emotional development during infancy and childhood. Low SES women face unique stressors and social challenges. Rates of postpartum depression are significantly higher in this group (23-33%) than in the general population (10-15%).

The purpose of this study is to understand how social circumstances, women's mood, and parenting techniques affect infant and child development. Specifically, investigators are interested in finding out whether a behavioral intervention, already being administered in IRB approved protocol #6285, targeting maternal caregiving of young infants can increase infant sleep and reduce fuss/cry behavior, thereby reducing the incidence and/or severity of maternal depression and anxiety symptoms, improving the quality of the mother-infant interaction, and improving infant developmental outcomes.

By collecting stress reports from women from low SES backgrounds during pregnancy and the postpartum period and by conducting follow-up observational assessments of the quality of mother-infant interaction, infant learning, infant cortisol reactivity, and infant neurocognitive development, investigators hope to identify whether this intervention can effectively meet these aims.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • New York
      • New York, New York, Forenede Stater, 10032
        • Columbia University Medical Center

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

18 år til 45 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Healthy pregnant women between 24 and 38 weeks gestation (based on self-report)
  • Ages 18-45 (based on self-report) 3. English speaking (based on self-report)
  • Salary indicated to be at New York City standardized "Struggling level" or lower - $47,700 annual for a family of 4 (based on self-report)
  • Experiencing one or more of nine social adversity hardships (based on self report)
  • Experiencing a healthy pregnancy, free from any significant medical complication (based on self-report)
  • Receiving standard prenatal care (based on self-report)

Exclusion Criteria:

  • Multi-fetal pregnancy (based on self-report)
  • Smoking, illicit drug use, or alcohol use during pregnancy (based on self-report)
  • Acute medical illness or significant pregnancy complication (based on self-report)
  • Currently in weekly, individual psychotherapy - group therapy and psychiatric management ok (based on self-report)
  • Psychotic d/o; Bipolar I; Major Depressive d/o (based on M.I.N.I.)

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
Eksperimentel: Resources for Postpartum Parenting
Behavioral intervention will include techniques to help mothers get their infants to cry/fuss less and sleep more to determine if this has an effect on prevalence of postpartum depression in low SES women and if it improves the quality of mother-infant interaction and subsequent child development.
Adfærdsmæssigt: Resources for Postpartum Parenting
The intervention includes four-sessions that targets maternal caregiving of young infants to increase infant sleep and reduce fuss/cry behavior and thereby simultaneously consolidate women's enjoyment of and confidence in their maternal role, this, in turn, promotes a cycle of a mutually re- warding engagement in the mother-infant dyad - the antithesis of a 'toxic' experience, and a strong foundation for improving the chances of a successful psychosocial adjustment, including adequate employment. Investigators believe PREPP holds tremendous promise as an intervention to fill the science-practice gap in the promotion of an optimal emotional environment for the developing infant, particularly for women and children living in poverty and/or facing significant psychosocial hardship.
Andre navne:
  • Practical Resources for Effective Postpartum Parenting
Ingen indgriben: Control Group
This group will not receive the coaching tips to help babies cry less and sleep more.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in maternal mood and prevalence/severity of postpartum depression.
Tidsramme: 6 weeks postpartum, 10 weeks postpartum, 16 weeks postpartum
Investigators will be assessing and tracking the incidence and/or severity of postpartum depression with the use of mood and stress questionnaires (Hamilton Depression Scale, Hamilton Anxiety Scale, Perceived Stress Scale, Center for Epidemiological Studies Depression Scale) administered at 4-6 weeks postpartum, 10 weeks postpartum, and 16 weeks postpartum.
6 weeks postpartum, 10 weeks postpartum, 16 weeks postpartum

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The effect of behavioral intervention for infants on infant development
Tidsramme: 4 months (infant age)
Investigators will use neurodevelopmental assessments (Bayley Scale of Infant Development, Still Face Protocol, Free Play Observation, and Conjugate Kicking Task) and cortisol reactivity to assess infant development at 4 months of age.
4 months (infant age)
The effect of behavioral intervention on infant sleep and fuss behavior
Tidsramme: 6 weeks, 4 months (infant age)
The infant's sleep and fuss/cry behavior will be assessed at 6 weeks and 16 weeks of age (Baby Day Diary)
6 weeks, 4 months (infant age)

Samarbejdspartnere og efterforskere

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

Sponsor

New York State Psychiatric Institute

Samarbejdspartnere

The Robin Hood Foundation

Efterforskere

  • Ledende efterforsker: Catherine Monk, Ph.D., NYPI, CUMC

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. marts 2014

Primær færdiggørelse (Faktiske)

1. december 2019

Studieafslutning (Faktiske)

1. december 2019

Datoer for studieregistrering

Først indsendt

28. marts 2014

Først indsendt, der opfyldte QC-kriterier

21. april 2014

Først opslået (Skøn)

23. april 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. januar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. januar 2020

Sidst verificeret

1. januar 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • #6889

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Fødselsdepression

Kliniske forsøg med Resources for Postpartum Parenting

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