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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01977326
Acronym
AFFIRM-SA
Enrollment
4205
Registered
2013-11-06
Start date
2013-10-31
Completion date
2016-06-30
Last updated
2016-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical Depression, Moderate Depression, Postpartum Depression

Keywords

task sharing, task shifting, prenatal depression, counselling, lay health workers

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: 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.

Interventions

BEHAVIORALbasic counselling by lay-health workers

6 sessions of manual based counselling by trained lay health workers

OTHEREnhanced usual care

3 monthly phone calls by trained lay health workers (without counselling)

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Cape Town
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Hamilton depression rating Scale (HAM-D)baseline, and change in scores at 1 month prenatally, 3 months and 12 months postnatally

Secondary

MeasureTime frameDescription
Mini International Psychiatric Interview 2.0.0 (MINI) Major depressionbaseline and change in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-upMajor 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.
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 2.0baseline and change in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
Edinburgh Postnatal depression scale (EPDS)baseline and change in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-upScreening tool to identify depressive symptoms; score of 13 or higher indicates a positive screen for depressive symptoms and woman is recruited into the study
Cape Town Functional Assessment Instrument for Maternal Depressionbaseline and changes in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-uplocally 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
Obstetric and Infant outcome measures (head circumference, weight, height, feeding, diarrhoea, respiratory tract infections, immunisationfollow-up 3 months postnatal follow-up 12 months postnatal follow-up
Health services utilisation questionnairebaseline and changes in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026