Clinical Trials Directory

Trials / Completed

CompletedNCT03378544

Engaging Traditional Birth Attendants to Reduce Maternal Depression in Rural Kenya

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
220 (actual)
Sponsor
Africa Institute of Mental and Brain Health (AFRIMEB) · Academic / Other
Sex
Female
Age
14 Years – 50 Years
Healthy volunteers
Accepted

Summary

Evidence from Low and Middle Income Countries has demonstrated the effectiveness of various psychosocial approaches for depression. However, there are no mental health specialists to deliver these interventions especially in rural African settings. This study aims at testing the effectiveness of mental health Global Action Programme (mhGAP-IG) psychosocial interventions among Traditional Birth Attendants (TBAs) for pregnant mothers. The outcomes of this intervention will result into depression reduction in the mothers that will lead to better care during pregnancy and for their infants, allowing for long-term impact on their physical and the psychological wellbeing and that of their children.

Detailed description

Evidence from Low and Middle Income Countries has demonstrated the effectiveness of various psychosocial approaches for depression. However, there are no mental health specialists to deliver these interventions especially in rural African settings. This study aims at testing the effectiveness of mental health Global Action Programme (mhGAP-IG) psychosocial interventions among Traditional Birth Attendants (TBAs) for pregnant mothers seeking the services of TBAs and suffering from maternal depression. A cluster randomized controlled trial with two sub-counties in Makueni County (rural Kenya) as the clusters, randomized into either intervention or control arms will be used. TBAs in the intervention arm will receive training on mhGAP-IG while those in the control arm will only be requested to refer patients to nearest clinics and continue with their routine care, except in circumstances of pregnancy-related complications or severe medical conditions. All pregnant mothers will be eligible for inclusion. Qualitative measures will be used to explore community and other stakeholder views regarding the integration of TBAs into mental health care and promoting dialogue with the formal health sector. Various questionnaires will be administered at 0, 3, 6 and 9 months in order to test the effectiveness of the intervention at various intervals. Interviews will be conducted at 9 months for randomly selected mothers receiving the intervention and those in the control arm, for purposes of describing and evaluating their experiences regarding use of TBA and health care workers' services. The survival and physical wellbeing of the baby will also be measured using the labour process, birth and subsequent weight of the baby, completed schedules of immunization and developmental milestones until 6 months. The outcomes of this intervention will result into depression reduction in the mothers that will lead to better care during pregnancy and for their infants, allowing for long-term impact on their physical and the psychological wellbeing and that of their children.

Conditions

Interventions

TypeNameDescription
BEHAVIORALmhGAPThe intervention will involve psycho-education to patients on the importance of maintaining interest in activities that they used to do, regular sleep cycles, physical activity and social activity

Timeline

Start date
2018-04-09
Primary completion
2019-08-31
Completion
2019-08-31
First posted
2017-12-20
Last updated
2025-10-03

Locations

1 site across 1 country: Kenya

Source: ClinicalTrials.gov record NCT03378544. Inclusion in this directory is not an endorsement.