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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.

Studieöversikt

Status

Avslutad

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

29

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Missouri
      • Saint Louis, Missouri, Förenta staterna, 63105
        • Washington University and Nurses for Newborns Foundations

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Andra namn:
  • Problemlösningsterapi
Inget ingripande: Enhanced Referral

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
PHQ-9
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Qualitative Interview
Tidsram: 1 month post treatment
Questions asking the participants their feelings about the intervention.
1 month post treatment

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Samarbetspartners

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2008

Primärt slutförande (Faktisk)

1 maj 2013

Avslutad studie (Faktisk)

1 maj 2013

Studieregistreringsdatum

Först inskickad

28 juli 2011

Först inskickad som uppfyllde QC-kriterierna

29 juli 2011

Första postat (Uppskatta)

2 augusti 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

11 maj 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 maj 2018

Senast verifierad

1 maj 2018

Mer information

Termer relaterade till denna studie

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Post-partum depression

Kliniska prövningar på Problem Solving Tools (PST)

3
Prenumerera