Evaluating CBT Delivered by Community Health Workers on Maternal Mental Health and Infant Cognitive Development in Insecure Environments

September 20, 2016 updated by: Heartland Alliance
This study evaluates a cognitive behavioral therapy intervention for mothers with symptoms of anxiety and depression living in insecure environments using a randomized controlled methodology. Key outcomes of interest include maternal mental health and infant cognitive development. The intervention will be delivered by community mental health workers who will be trained to administer 8 to 12 cognitive behavioral therapy sessions.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

262

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women in their third trimester of pregnancy
  • Who exhibited symptoms of anxiety and depression

Exclusion Criteria:

  • Women who express suicidality

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
Receives 8-12 weeks of one-on-one Cognitive Behavioral Therapy sessions
Behavioral: Cognitive Behavioral Therapy
No Intervention: Control Group
Receives no intervention during data-collection phase. Participants in this group will receive the intervention post-data collection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptoms of anxiety and depression as measured by Hopkins Symptoms Checklist
Time Frame: 10 months post-birth of their infant
10 months post-birth of their infant
Infant Cognitive Development as measured by Mullen Scales of Early Learning
Time Frame: 10 months post-birth
10 months post-birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heartland Alliance

Investigators

  • Principal Investigator: Constantin Kahorha, Heartland Alliance International

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

September 19, 2016

First Submitted That Met QC Criteria

September 20, 2016

First Posted (Estimate)

September 22, 2016

Study Record Updates

Last Update Posted (Estimate)

September 22, 2016

Last Update Submitted That Met QC Criteria

September 20, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0721-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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