Essential Coaching for Every Mother in Tanzania

Postpartum Depression Clinical Trial

— ECEMTZ  

Official title:

Essential Coaching for Every Mother: Developing and Evaluating a Text Message Postnatal Education Intervention for Mothers of Newborns in Tanzania

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05362305
• Other study ID #: ECEMTZ
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2024
• Est. completion date: January 2025

Study information

• Verified date: June 2024
• Source: IWK Health Centre
• Contact: Justine Dol, PhD
• Phone: 902-470-7706
• Email: justine.dol[@]dal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate a text message intervention called Essential Coaching for Every Mother in Tanzania to improve mothers' access to essential newborn care information during the immediate six-week postnatal period.

Description:

This is a 2-group parallel arm randomized controlled trial. Participants will be randomized into either the intervention or a control group. No changes to in-person care will occur.

This study will be conducted in Dar es Salaam, Tanzania with mothers recruited from a Tanzanian postnatal ward who have recently given birth at four different hospitals. Participants in the intervention group will start receiving the Essential Coaching for Every Mother program based on their delivery date up to six weeks postpartum. Mothers in the control group will not receive any text messages. Both groups will be asked to complete an survey at enrolment and six-weeks postpartum.

The investigators aim to recruitment 180 participants in total, 90 per group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: January 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• have recently given birth within the hospital within 48 hours

• have daily access to a mobile phone with text message capabilities

• are over 18 years of age

• speak and read English or Swahili.

Exclusion Criteria:

• newborns die or are expected to die prior to leaving the hospital

• they have no access to mobile phone, either personal or shared

• unwilling to receive text messages

• decline to participate

• are experiencing major postnatal complications expected to impact learning or ability to consent while in the hospital (e.g., postpartum hemorrhage, seizures)

• participated in Phase I of this project.

Related Conditions & MeSH terms

• Depression, Postpartum
• Postpartum Anxiety
• Postpartum Depression

Intervention

Behavioral:
• Essential Coaching for Every Mother
Daily text messages for the first six-weeks postpartum.

Locations

Country	Name	City	State
Tanzania	Muhimbili University of Health and Allied Sciences	Dar Es Salaam

Sponsors (1)

Lead Sponsor	Collaborator
IWK Health Centre

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Effectiveness	Number of participants enrolled versus approached. Number of participants per hospital site.	Enrolment
Primary	Implementation Dose	Dose delivered - number of text messages sent. Output data available through the Africa's Talking and TextIt platforms will be collected per participant.	Enrolment and study completion (6 weeks)
Primary	Implementation Engagement	Un-subscription rates/drop out after enrolment. Output data available through the Africa's Talking and TextIt platforms will be collected per participant.	Enrolment and study completion (6 weeks)
Primary	Implementation Quality	Mothers in the intervention group will be asked about the number of messages they recall receiving, user experience, perspectives on the frequency and timing of messages, and what did they like and not like about Essential Coaching for Every Mother.	Six-weeks postpartum
Secondary	Newborn Care Knowledge	Knowledge will be assessed using a modified questionnaire developed by McConnell and colleagues. Questions will determine whether mothers can identify danger signs, hand washing practices, cord care, newborn thermal care, and breastfeeding. A summative score will be created with a maximum of five points and a minimum of zero, where each point represents knowledge on the above postnatal health topics.	Baseline (enrolment), and six-weeks postpartum (follow-up)
Secondary	Maternal Self-Efficacy	Parenting self-efficacy will be measured using the Karitane Parenting Confidence Scale (KPCS) tool. This 15-item tool was developed to assess perceived self-efficacy of mothers of newborns birth to twelve months of age. A cut off score of 39 or less (out of a possible 45) was determine to be a clinically low perceived parenting self-efficacy (PPSE).	Baseline (enrolment), and six-weeks postpartum (follow-up)
Secondary	Breastfeeding Self-Efficacy	Breastfeeding self-efficacy will be measured using the Breastfeeding Self-Efficacy Scale - Short Form. Higher scores indicate higher breastfeeding self-efficacy.	Baseline (enrolment), and six-weeks postpartum (follow-up)
Secondary	Postpartum Depression	Depression will be measured using the Edinburgh Postnatal Depression Scale (EPDS). The EPDS is a self-report screening scale with 10 items that can indicate if a respondent has symptoms related to perinatal depression with a score >12 considered high symptoms of depression.	Baseline (enrolment), and six-weeks postpartum (follow-up)
Secondary	Postpartum Anxiety	Anxiety will be measured using the Generalized Anxiety Disorder (GAD)-7, which is a 7-item scale used to assess generalized anxiety disorder. The scale ranges between 0 and 21, with scores of 10 or greater indicative of generalized anxiety at a moderate/severe level.	Baseline (enrolment), and six-weeks postpartum (follow-up)
Secondary	Newborn morbidity	Data will be collected on number of morbidities (e.g., diarrhea, jaundice, infection) identified per infant enrolled in the study within the 6-weeks.	Six-weeks postpartum (follow-up)
Secondary	Newborn mortality	Data will be collected on newborn mortality (e.g., number of infant deaths during study).	Six-weeks postpartum (follow-up)
Secondary	Need for readmission	Data will be collected on number of readmission to hospital for the infant and mothers during the six weeks and related reason.	Six-weeks postpartum (follow-up)
Secondary	Postnatal Clinic Attendance	Data will be collected on the number and date of postnatal contact.	Six-weeks postpartum (follow-up)