NCT01407783

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 2, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

4.8 years

First QC Date

July 28, 2011

Last Update Submit

May 4, 2018

Conditions

Keywords

Post-partum depressionLow-income mothershome nurse visitation

Outcome Measures

Primary Outcomes (2)

  • PHQ-9

    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

    Measure the reduction of post partum depression after intervention at 6 months and 12 months post treatment.

    baseline, 6months &12 months post treatment

Secondary Outcomes (1)

  • Qualitative Interview

    1 month post treatment

Study Arms (2)

Problem Solving Tools

EXPERIMENTAL

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.

Behavioral: Problem Solving Tools (PST)

Enhanced Referral

NO INTERVENTION

Interventions

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.

Also known as: Problem Solving Therapy
Problem Solving Tools

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University and Nurses for Newborns Foundations

St Louis, Missouri, 63105, United States

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Luis H Zayas, Ph.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2011

First Posted

August 2, 2011

Study Start

August 1, 2008

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

May 11, 2018

Record last verified: 2018-05

Locations