NCT01816945

Brief Summary

The investigators' mobile application-based community, termed Momba, will provide a bi-directional flow of information on maternal and infant mental health to traditionally underrepresented groups of mothers and their infants. The overall goal of this mobile application-based community of low-income postpartum women and infants is to increase the social support, social networks, and social capital of low-income mothers; thereby, leading to a positive change in the health behaviors, utilization of health services, and mental health status of both mothers and their infants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration 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

First Submitted

Initial submission to the registry

February 26, 2013

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 22, 2013

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

May 18, 2021

Completed
Last Updated

May 18, 2021

Status Verified

April 1, 2021

Enrollment Period

2.2 years

First QC Date

February 26, 2013

Results QC Date

March 16, 2021

Last Update Submit

April 26, 2021

Conditions

Mental Health Wellness 1

Keywords

DepressionStressSocial supportSocial capitalMaternal

Outcome Measures

Primary Outcomes (2)

  • Phone Retention

    To determine the potential feasibility of providing smartphones to participants and delivering and intervention through the smartphone, phone retention was measured. Phone retention was defined as the ability of participants to retain the phone over the study period. Outcome measure used was how many participants did not need a replacement phone during the study period.

    15 months

  • Test the Proper Operating and Functioning of the MOMBA Application

    To Test the proper operating and functioning of the MOMBA application, the number of participants that received training was assessed. Intervention subjects were trained (together) on the operating and functions (including how to use the privacy settings) of the Momba application and the phone. The control subjects were trained (together) on how to complete the control questionnaires and how to use the phone.

    Baseline

Secondary Outcomes (1)

  • Acceptability and Performance of Structured Questionnaires

    12 months

Other Outcomes (2)

  • Patient Health

    12 months

  • Confident Network Score

    12 months

Study Arms (2)

Access to MOMBA web-based application

EXPERIMENTAL

Study will provide the subject with a smartphone, pay the data plan, and facilitate access to the web-based application for purposes of researching the acceptability of the application, the operating and functioning of it, and its impact on maternal mental health.

Behavioral: MOMBA web-based application

Smartphone only

NO INTERVENTION

Study will provide the subject with a smartphone and pay the data plan. Weekly assessments are completed through internet survey links sent via text message.

Interventions

MOMBA web-based applicationBEHAVIORAL

Web-based, interactive, social network application.

Access to MOMBA web-based application

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women will be recruited in their third trimester of pregnancy from Yale-New Haven Hospital (YNHH) and followed for 8 months postpartum.
  • Women are eligible if they are over the age of 18, in their third trimester of pregnancy, will deliver a baby at YNHH and receive prenatal care at the Women's Center.
  • Meet criteria for minor or major depressive disorder.

You may not qualify if:

  • Mothers are not eligible to participate if they have previously given birth
  • Are placing the baby for adoption
  • Are planning to move in the next 18 months
  • Are actively suicidal, psychotic or unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Results Point of Contact

Title
Megan Smith Associate Professor
Organization
Yale University
megan.smith@yale.edu
203 764 8655

Study Officials

  • Megan V Smith, DrPH

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

February 26, 2013

First Posted

March 22, 2013

Study Start

April 1, 2013

Primary Completion

June 1, 2015

Study Completion

September 1, 2015

Last Updated

May 18, 2021

Results First Posted

May 18, 2021

Record last verified: 2021-04

Locations

US(1)