Parenting Self EfficacyECEMTZNCT05362305
Essential Coaching for Every Mother in Tanzania
A study testing Essential Coaching for Every Mother in people with Parenting Self Efficacy and Postpartum Depression, run by IWK Health Centre at 1 site in Tanzania.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Parenting Self Efficacy, Postpartum Depression, Postpartum Anxiety
- What is being tested?
- Essential Coaching for Every Mother
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteTanzania
- Study dates
- 13 Jun 2024to 21 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Muhimbili University of Health and Allied Sciences
Dar es Salaam
About this study
Official title: Essential Coaching for Every Mother: Developing and Evaluating a Text Message Postnatal Education Intervention for Mothers of Newborns in Tanzania
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.
Read the detailed 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 a survey at enrolment and six-weeks postpartum.
The investigators aim to recruitment 124 participants in total, 62 per group.
- Conditions
- Parenting Self Efficacy, Postpartum Depression, Postpartum Anxiety, Breastfeeding Self-Efficacy, Newborn Knowledge
- Being tested
- Essential Coaching for Every Mother
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential Coaching for Every MotherBehavioural
Daily text messages for the first six-weeks postpartum.
| Study group | Role | What they receive |
|---|---|---|
| Essential Coaching for Every Mother | Experimental | Mothers in the intervention group will receive in-hospital education by a non-study nurse midwife while on the postnatal ward prior to discharge as per standard protocol on the unit. On the third day after birth, mothers will receive daily text messages to 6 weeks postpartum. The messages will be sent automatically each day based on the date of birth of the infant. Receives: Behavioral: Essential Coaching for Every Mother |
| Standard Care | No intervention | Mothers will receive in-person education provided by a non-study nurse midwife while on the postnatal ward prior to discharge as per current standard protocol on the unit. Mothers in this group will not receive any further text messages from the program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (enrolment), and six-weeks postpartum (follow-up)
Secondary outcomes (8)
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).
Measured: Baseline (enrolment), and six-weeks postpartum (follow-up)
Breastfeeding Self-Efficacy
Breastfeeding self-efficacy will be measured using the Breastfeeding Self-Efficacy Scale - Short Form. Higher scores indicate higher breastfeeding self-efficacy.
Measured: Baseline (enrolment), and six-weeks postpartum (follow-up)
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.
Measured: Baseline (enrolment), and six-weeks postpartum (follow-up)
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.
Measured: Baseline (enrolment), and six-weeks postpartum (follow-up)
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.
Measured: Six-weeks postpartum (follow-up)
Newborn mortality
Data will be collected on newborn mortality (e.g., number of infant deaths during study).
Measured: Six-weeks postpartum (follow-up)
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.
Measured: Six-weeks postpartum (follow-up)
Postnatal Clinic Attendance
Data will be collected on the number and date of postnatal contact.
Measured: Six-weeks postpartum (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start13 Jun 2024
- Primary completion21 Sep 2024
- Study completion21 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parenting Self EfficacyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justine Dol, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362305
- Sponsor's protocol ID
- ECEMTZ
- Acronym
- ECEMTZ
- Status last verified
- Oct 2024
- First submitted
- 22 Apr 2022
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dol J, Mselle LT, Campbell-Yeo M, Mbekenga C, Kohi T, McMillan D, Dennis CL, Tomblin Murphy G, Aston M. Essential Coaching for Every Mother Tanzania (ECEM-TZ): Protocol for a Type 1 Hybrid Effectiveness-Implementation Randomized Controlled Trial. JMIR Res Protoc. 2024 Dec 5;13:e63454. doi: 10.2196/63454.
PubMed 39636672
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Essential Coaching for Every Mother: Developing and Evaluating a Text Message Postnatal Education Intervention for Mothers of Newborns in Tanzania
- ClinicalTrials.gov ID
- NCT05362305
- Acronym / sponsor ID
- ECEMTZ / ECEMTZ
- Conditions
- Parenting Self Efficacy, Postpartum Depression, Postpartum Anxiety, Breastfeeding Self-Efficacy, Newborn Knowledge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 21 Sep 2024 (actual)
- Study completion
- 21 Sep 2024 (actual)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 a survey at enrolment and six-weeks postpartum.
The investigators aim to recruitment 124 participants in total, 62 per group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Essential Coaching for Every Mother | Experimental | Behavioral: Essential Coaching for Every MotherMothers in the intervention group will receive in-hospital education by a non-study nurse midwife while on the postnatal ward prior to discharge as per standard protocol on the unit. On the third day after birth, mothers will receive daily text messages to 6 weeks postpartum. The messages will be sent automatically each day based on the date of birth of the infant. |
| Standard Care | No intervention | –Mothers will receive in-person education provided by a non-study nurse midwife while on the postnatal ward prior to discharge as per current standard protocol on the unit. Mothers in this group will not receive any further text messages from the program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Essential Coaching for Every MotherDaily text messages for the first six-weeks postpartum. | Behavioural | Essential Coaching for Every Mother |
Primary outcome
Newborn Care Knowledge
Time frame: Baseline (enrolment), and six-weeks postpartum (follow-up)
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.
8 secondary outcomes
Maternal Self-Efficacy
Time frame: Baseline (enrolment), and six-weeks postpartum (follow-up)
Breastfeeding Self-Efficacy
Time frame: Baseline (enrolment), and six-weeks postpartum (follow-up)
Postpartum Depression
Time frame: Baseline (enrolment), and six-weeks postpartum (follow-up)
Postpartum Anxiety
Time frame: Baseline (enrolment), and six-weeks postpartum (follow-up)
Newborn morbidity
Time frame: Six-weeks postpartum (follow-up)
Newborn mortality
Time frame: Six-weeks postpartum (follow-up)
Need for readmission
Time frame: Six-weeks postpartum (follow-up)
Postnatal Clinic Attendance
Time frame: Six-weeks postpartum (follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Derived from this study: PubMed 39636672Dol J, Mselle LT, Campbell-Yeo M, Mbekenga C, Kohi T, McMillan D, Dennis CL, Tomblin Murphy G, Aston M. Essential Coaching for Every Mother Tanzania (ECEM-TZ): Protocol for a Type 1 Hybrid Effectiveness-Implementation Randomized Controlled Trial. JMIR Res Protoc. 2024 Dec 5;13:e63454. doi: 10.2196/63454.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Essential Coaching for Every Mother in people with Parenting Self Efficacy and Postpartum Depression, run by IWK Health Centre at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Newborn Care Knowledge (time frame: Baseline (enrolment), and six-weeks postpartum (follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05362305, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.