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Systems of Care for New Moms: Integrating Depression Treatment (NUMOMS)

NUMOMS involves collaboration between Nurses for Newborns Foundation and Washington University in St. Louis. This study explores the co-location of depression treatment within nurse home visitation and the organizational changes needed to maintain access to evidence-based treatment. Problem Solving Tools (PST) was chosen as the depression treatment because it is well suited for use by non-mental health specialists and for in-home treatment. It is also a brief treatment (4-8 sessions) takes a non-pathologizing approach.

Studieoversikt

Status

Fullført

Detaljert beskrivelse

NUMOMS involves collaboration between Nurses for Newborns Foundation and Washington University in St. Louis. This study explores the co-location of depression treatment within nurse home visitation and the organizational changes needed to maintain access to evidence-based treatment. Problem Solving Tools (PST) was chosen as the depression treatment because it is well suited for use by non-mental health specialists and for in-home treatment. It is also a brief treatment (4-8 sessions) takes a non-pathologizing approach.

In the first part of the study we will gather information from women and their providers to determine what system and treatment modifications are needed to effectively deliver acceptable depression treatment in home visitation programs. Based on this information, a panel of local and national experts will provide advice on decisions regarding the intervention adaptation. Once these adaptation decisions are made a small group of experts will adapt a PST manual for use in home visitation.

In the second phase of the NUMOMS study we will carry out a small two-arm randomized trial comparing the effectiveness, acceptability, and practicality of PST provided by home visitation RNs versus usual care (referral to mental health specialty care).

Significantly, NUMOMS has the potential to provide home visitation agencies with a viable means of access to effective and acceptable depression treatment for mothers in the face of policy mandates for depression screening.The specific aims are to:

  1. Adapt PST for implementation in nurse home visitation programs.

    1. Examine internal (organization and client level) and external (community and policy level) factors that may impact upon PST adaptation and delivery in nurse home visitation.
    2. Build protocols for targeting depression treatment to the woman's symptom severity and patient preferences.
    3. Develop and routinize protocols for supervision, clinical consultation, and risk assessment for PST provided by nurse home visitors.
    4. Modify protocols and systems for client tracking and outcomes.
  2. Implement a two-arm randomized pilot study comparing: PST provided by non-mental health home visitation nurses and referral for treatment (Care as Usual).

    1. Compare outcomes on the Beck Depression Inventory, the Patient Health Questionnaire-9, and Parenting Stress Index for women treated with PST by non-specialty RNs and Care as Usual.
    2. Track pathways and barriers to care for women referred to mental health specialty care or primary care for medications.
    3. Develop an R01 for a full scale randomized controlled trial using data on effect sizes and addressing organizational issues, infrastructure needs, and treatment refinements.

Studietype

Intervensjonell

Registrering (Faktiske)

29

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Missouri
      • Saint Louis, Missouri, Forente stater, 63105
        • Washington University and Nurses for Newborns Foundations

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • Depressed as indicated by Edinburgh Postpartum Depression Scale or Clinical Checklist
  • NFNF client from a certain zip code
  • Either pregnant or have a child under the age of 12 months in the home

Exclusion Criteria:

  • Under the age of 18
  • Severe Mental Illness
  • Chemical Dependency

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Problem Solving Tools
The home visitation nurse will teach and utilize the problem solving tools to help low-income depressed mothers. It is a brief treatment with the a non-pathologizing intervention being done in 4-8 sessions.
The problem solving tools was chosen as the depression treatment because it is well suited for use by non-mental health professionals and for in-home treatment. It is also a brief treatment (4-8 sessions) that takes a non-pathologizing approach.
Andre navn:
  • Problemløsende terapi
Ingen inngripen: Enhanced Referral

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
PHQ-9
Tidsramme: baseline, 6months and 12 months post treatment
Measure the reduction of post partum depression after intervention at 6 months and 12 months post treatment.
baseline, 6months and 12 months post treatment
BDI-II
Tidsramme: baseline, 6months &12 months post treatment
Measure the reduction of post partum depression after intervention at 6 months and 12 months post treatment.
baseline, 6months &12 months post treatment

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Qualitative Interview
Tidsramme: 1 month post treatment
Questions asking the participants their feelings about the intervention.
1 month post treatment

Samarbeidspartnere og etterforskere

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

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Luis H Zayas, Ph.D., Washington University School of Medicine

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. august 2008

Primær fullføring (Faktiske)

1. mai 2013

Studiet fullført (Faktiske)

1. mai 2013

Datoer for studieregistrering

Først innsendt

28. juli 2011

Først innsendt som oppfylte QC-kriteriene

29. juli 2011

Først lagt ut (Anslag)

2. august 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. mai 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. mai 2018

Sist bekreftet

1. mai 2018

Mer informasjon

Begreper knyttet til denne studien

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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