Task Sharing Counseling Intervention by Community Health Workers for Prenatal Depression in South Africa (AFFIRM-SA)

October 27, 2016 updated by: A/Prof Crick Lund, University of Cape Town

The Effectiveness and Cost-effectiveness of a Task Sharing Counseling Intervention by Community Health Workers for Prenatal Depression in South Africa

The objective of this randomised controlled trial (RCT) is to determine the effectiveness and cost-effectiveness of a task sharing counseling intervention for maternal depression in South Africa(i.e. provided by non-specialist health workers)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Specific Objectives:

  1. To determine the effectiveness and cost-effectiveness of task sharing care to community health workers (CHWs), compared to enhanced usual care in South Africa, on both primary outcome measures (severity of prenatal maternal depression symptoms) and on a series of secondary outcome measures (functional status, health care utilization, social support and postnatal infant growth).
  2. To examine factors influencing the implementation of the task sharing intervention and future scale up, by assessing feasibility, sustainability, quality, and safety, and by qualitative exploration of the experience of task sharing from the perspectives of both CHWs and patients.

Study Type

Interventional

Enrollment (Actual)

4205

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

  • South Africa
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7000
        • Michael Mapongwana Clinic
      • Cape Town, Western Cape, South Africa
        • Site B Clinic

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Women attending antenatal clinics at the Michael Mapongwana Community Health Centre in Khayelitsha, presenting for their first booking appointment, no later than 28 weeks gestation
  2. Living in Khayelitsha
  3. 18 years or older
  4. Screen positive for depression with a cut off of 13 or more on the EPDS
  5. Able to give informed consent

Exclusion Criteria:

  • Require urgent medical attention or have severe mental health problems, defined as a diagnosis of schizophrenia, bipolar mood disorder, or currently experiencing an episode of psychosis.
  • Women who do not speak isiXhosa as a first language

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: counseling intervention
Each woman recruited into the intervention arm will undergo 6 sessions of basic counselling by lay-health workers
Behavioral: basic counselling by lay-health workers
6 sessions of manual based counselling by trained lay health workers
Other Names:
  • task sharing intervention for maternal depression
Active Comparator: Enhanced usual care
usual antenatal care with additional 3 - 4 monthly phone calls.
Other: Enhanced usual care
3 monthly phone calls by trained lay health workers (without counselling)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hamilton depression rating Scale (HAM-D)
Time Frame: baseline, and change in scores at 1 month prenatally, 3 months and 12 months postnatally
baseline, and change in scores at 1 month prenatally, 3 months and 12 months postnatally

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Edinburgh Postnatal depression scale (EPDS)
Time Frame: baseline and change in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
Screening tool to identify depressive symptoms; score of 13 or higher indicates a positive screen for depressive symptoms and woman is recruited into the study
baseline and change in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
Mini International Psychiatric Interview 2.0.0 (MINI) Major depression
Time Frame: baseline and change in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
Major Depression and Suicidality modules are used. A score of 17 or higher on the suicidality module indicates need for referral for additional treatment. These women remain in the trial.
baseline and change in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
Multidimensional Scale of Perceived Social Support (MSPSS)
Time Frame: baseline and change in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
baseline and change in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
WHO Disability Assessment Schedule (WHO-DAS) 12 item version 2.0
Time Frame: baseline and change in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
baseline and change in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
Health services utilisation questionnaire
Time Frame: baseline and changes in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
baseline and changes in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
Cape Town Functional Assessment Instrument for Maternal Depression
Time Frame: baseline and changes in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
locally relevant functional assessment instrument developed for use with the specific target population of the trial - pregnant women and mothers of young babies living in Khayelitsha, Cape Town - the study site. This outcome measure complements the WHO-DAS 2.0
baseline and changes in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
Obstetric and Infant outcome measures (head circumference, weight, height, feeding, diarrhoea, respiratory tract infections, immunisation
Time Frame: follow-up 3 months postnatal follow-up 12 months postnatal follow-up
follow-up 3 months postnatal follow-up 12 months postnatal follow-up

Collaborators and Investigators

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

Sponsor

University of Cape Town

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Crick Lund, PhD, University of Cape Town
  • Principal Investigator: Ezra Susser, PhD, Mailman School of Public Health, Columbia University
  • Principal Investigator: Atalay Alem, PhD, Addis Ababa University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2013

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

October 24, 2013

First Submitted That Met QC Criteria

October 30, 2013

First Posted (Estimate)

November 6, 2013

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5U19MH095699-02 (U.S. NIH Grant/Contract)
  • 1U19MH095699 (U.S. NIH Grant/Contract)

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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