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

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ClinicalTrials.gov Identifier: NCT01977326
Recruitment Status : Completed
First Posted : November 6, 2013
Last Update Posted : October 28, 2016
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
A/Prof Crick Lund, University of Cape Town

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)

Condition or disease Intervention/treatment Phase
Moderate Depression Clinical Depression Postpartum Depression Behavioral: basic counselling by lay-health workers Other: Enhanced usual care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4205 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Effectiveness and Cost-effectiveness of a Task Sharing Counseling Intervention by Community Health Workers for Prenatal Depression in South Africa
Study Start Date : October 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


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 Name: 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)




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

Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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

  7. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01977326


Locations
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South Africa
Michael Mapongwana Clinic
Cape Town, Western Cape, South Africa, 7000
Site B Clinic
Cape Town, Western Cape, South Africa
Sponsors and Collaborators
University of Cape Town
National Institute of Mental Health (NIMH)
Investigators
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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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: A/Prof Crick Lund, Professor, University of Cape Town
ClinicalTrials.gov Identifier: NCT01977326     History of Changes
Other Study ID Numbers: 5U19MH095699-02 ( U.S. NIH Grant/Contract )
1U19MH095699 ( U.S. NIH Grant/Contract )
First Posted: November 6, 2013    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Keywords provided by A/Prof Crick Lund, University of Cape Town:
task sharing
task shifting
prenatal depression
counselling
lay health workers
Additional relevant MeSH terms:
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Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications