Engaging Traditional Birth Attendants to Reduce Maternal Depression in Rural Kenya
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Reduction in depressive symptoms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gestational age of between 16 and 26 weeks
- •A positive score on EPDS
- •Confirmed diagnosis of depression using the Mini International Psychiatric Interview
- •Provision of an informed consent
排除标准
- •Actively suicidal
- •Severe mental disorders and/or medical conditions requiring immediate medical attention
- •A negative score on EPDS
- •Pregnancy-related complications
- •Decline to provide informed consent
结局指标
主要结局
Reduction in depressive symptoms
时间窗: 0, 3, 6, and 9 months
The proportion of patients (mothers with maternal depression) with reduction of depressive symptoms at 3, 6, and 9 months from baseline, using the Edinburgh Postnatal Depression Scale. This tool has adequate sensitivity and specificity to identify depressive symptoms in the antenatal and postnatal periods. A score is calculated by adding the individual items for each question. A total score of 11 or more in the Kenyan context is considered a flag for the need for follow up of possible depressive symptoms.
次要结局
- Suicidality(0, 3, 6, and 9 months)
- Disability(0, 6, and 9 months)
- Satisfaction levels(0, 3, 6, and 9 months)
- Intimate Partner violence(Baseline)
- Quality of life of mothers with depression(0, 3, 6, and 9 months)