Task Sharing Counseling Intervention by Community Health Workers for Prenatal Depression in South Africa

Study Overview
=================
Brief Summary
-----------------
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)

Detailed Description
-----------------
Specific Objectives: 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). 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.

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

Conditions
-----------------
Moderate Depression, Clinical Depression, Postpartum Depression

Intervention / Treatment
-----------------
* Behavioral: basic counselling by lay-health workers
* Other: Enhanced usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Living in Khayelitsha 18 years or older Screen positive for depression with a cut off of 13 or more on the EPDS 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: counseling intervention<br>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<br>* 6 sessions of manual based counselling by trained lay health workers<br>* Other names: task sharing intervention for maternal depression;|
| Active Comparator: Enhanced usual care<br>usual antenatal care with additional 3 - 4 monthly phone calls. | Other: Enhanced usual care<br>* 3 monthly phone calls by trained lay health workers (without counselling)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton depression rating Scale (HAM-D) |  | 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) | 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 | 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) |  | 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 |  | 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 |  | 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 | 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 |  | follow-up 3 months postnatal follow-up 12 months postnatal follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
task sharing, task shifting, prenatal depression, counselling, lay health workers