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Engaging Traditional Birth Attendants to Reduce Maternal Depression in Rural Kenya (ENGAGE-TBA)

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ClinicalTrials.gov Identifier: NCT03378544
Recruitment Status : Active, not recruiting
First Posted : December 20, 2017
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Africa Mental Health Foundation

Brief 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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: mhGAP Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A cluster randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Engaging Traditional Birth Attendants to Reduce Maternal Depression in Rural Kenya
Actual Study Start Date : April 9, 2018
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental arm
Patients with suicidal ideation and depression will receive psychosocial interventions adapted from the WHO mental health Global Action Programme Intervention Guide (mhGAP-IG). The 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.
Behavioral: mhGAP
The 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

No Intervention: Control group
Patients with suicidal ideation and depression will be trained on how to refer patients suffering from depression, using a referral note to the nearest health centre for further treatment



Primary Outcome Measures :
  1. Reduction in depressive symptoms [ Time Frame: 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.


Secondary Outcome Measures :
  1. Intimate Partner violence [ Time Frame: Baseline ]
    The proportion of depressed patients at the TBA clinics experiencing intimate partner violence using the World Health Organization instrument to measure partner violence. This questionnaire measures violence from various aspects such as (i) physical, sexual, emotional, controlling behaviours and physical violence in pregnancy; (ii) physical and forms of violence by non-partners since age 15 years and (iii) Childhood sexual abuse before age 15 years. A "yes" in any of the items in the specific forms of violence indicates a positive score for that type of violence.

  2. Quality of life of mothers with depression [ Time Frame: 0, 3, 6, and 9 months ]
    Change from baseline to 3, 6, and 9 months in quality of life domains using the World Health Organization Quality of Life questionnaire. The minimum and maximum scores for physical, psychological, social and environmental domains are (7-35), (6-30), (3-15) and (8-40) respectively. The domains are scored through a simple algebraic summation of each item in that scale and the raw scores transformed into a 0-100 scale by subtracting lowest possible raw score from actual raw score and dividing the total by the possible raw score range, then the total is multiplied by 100. Higher scores on each of the domains indicate higher quality of life.

  3. Satisfaction levels [ Time Frame: 0, 3, 6, and 9 months ]
    Change in satisfaction levels among patients seeking TBA services

  4. Suicidality [ Time Frame: 0, 3, 6, and 9 months ]
    The proportion of patients with reduced suicidal behaviors such as ideations or attempts as measured using the Beck's Suicidality Scale at 3, 6, and 9 months. This scale assesses a patient's thoughts, plans and intent to commit suicide. There are no specific cut-off scores for severity classification. Therefore, the total scores calculated through summation of the items range from 0 to 42. Increasing scores reflect greater suicide risk.

  5. Disability [ Time Frame: 0, 6, and 9 months ]
    Change from baseline to 6, and 9 months in disability scores using the World Health Organization Disability Assessment Schedule. This scale asks difficulties related to health/mental conditions. The "item-response-theory" (IRT)-based scoring which takes into account multiple levels of difficulty for each item is used. After summing the scores for all six different functioning domains: cognition, mobility, self-care, getting along, life activities (household and work/school) and participation, the summary scores are converted into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability). High scores on a particular domain indicate significant and problematic areas for the individual.



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Ages Eligible for Study:   14 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant mothers seeking the services of traditional birth attendants
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT03378544


Locations
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Kenya
Tawa and Kanzokea
Makueni, Kenya
Sponsors and Collaborators
Africa Mental Health Foundation
Investigators
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Principal Investigator: Christine W Musyimi Africa Mental Health Foundation

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Responsible Party: Africa Mental Health Foundation
ClinicalTrials.gov Identifier: NCT03378544     History of Changes
Other Study ID Numbers: AfricaMHF
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders