Maternal DistressECEMNCT04730570
Essential Coaching for Every Mother, a Postpartum Text Message Program for Canadian Mothers
A study testing Essential Coaching for Every Mother in people with Maternal Distress, run by IWK Health Centre at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate a text message-based program called Essential Coaching for Every Mother which sends daily text messages 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
- Maternal Distress
- 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
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 5 Jan 2021to 21 Jan 2022
- 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
- To enroll antenatally, participants must:
- be at least 37 weeks pregnant
- have daily access to a mobile phone with text message capabilities
- are over 18 years of age
- speak and read English
- live in Nova Scotia, Canada.
Show all 12Show fewer
- To enroll postnatally, participants must:
- have an infant under 10 days of age
- have daily access to a mobile phone with text message capabilities
- are over 18 years of age
- speak and read English
- live in Nova Scotia, Canada.
Who cannot join
- newborn 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 or withdraw to participate
- participated in Phase I of this project.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Essential Coaching for Every Mother: A Randomized Controlled Trial Evaluating an Text Message Postpartum Program for Mothers
The purpose of this study is to evaluate a text message-based program called Essential Coaching for Every Mother which sends daily text messages during the immediate six-week postnatal period. Essential Coaching for Every Mother consists of standardized text messages that provide evidence-based information that women should be aware of related to caring for their newborn and maternal mental health.
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, stratified by parity. No changes to in-person care will occur.
Mothers in the intervention group will receive daily text messages from enrollment after birth until six-weeks postpartum.
Mothers in the control group will receive no content messages.
Mothers will be recruited both antenatally and postnatally through social media and study posters. All recruitment and participant engagement will occur remotely via text message. Women who are 37+ weeks pregnant up to 10 days postpartum will be eligible to send a text to a study specific number and complete an eligibility screening. If determined eligible once they deliver, the participant will be randomized into the intervention or control group and they will be asked to complete an electronic consent form and the baseline survey. 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 only receive reminder texts to complete the follow-up surveys. Both groups will be asked to complete an online survey at enrolment, six-weeks and six-months postpartum.
The investigators aim to recruitment 140 participants in total, 70 per group.
- Conditions
- Maternal Distress
- Being tested
- Essential Coaching for Every Mother
- Keywords
- maternal self-efficacy, postpartum depression, postpartum anxiety, mobile health education, postpartum support
- 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
Essential Coaching for Every Mother consists of 53 standardized text messages that provide evidence-based information that women should be aware of related to caring for their newborn and maternal mental health. Messages are personalized with the name of the child. Messages sent from birth to six-weeks postpartum, with two messages sent per day in the first two weeks and a daily message for weeks 3-6. The following topics covered in Essential Coaching for Every Mother include anxiety, depression, maternal self-care, postnatal follow-up, breastfeeding or formula feeding, infant concerns, cord care, well-baby care, normal development, crying, and safe sleep. Women who receive the messages will be able to self-select breastfeeding or formula feeding messages.
| Study group | Role | What they receive |
|---|---|---|
| Essential Coaching for Every Mother Intervention | Experimental | Women in the intervention arm will receive the Essential Coaching for Every Mother messages up to six-weeks postpartum. No changes in standard care. Receives: Behavioral: Essential Coaching for Every Mother |
| Standard care | No intervention | Women in the control group will receive no content messages. No changes in standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self Efficacy
Karitane Parenting Confidence Scale (Minimum: 0, Maximum: 45; Higher score indicates greater self-efficacy)
Measured: Change from enrolment (baseline) to six-weeks
Secondary outcomes (7)
Social support
Multidimensional Scale of Perceived Social Support (For the sub-scales of family, friends, and significant other [Minimum: 0, Maximum: 4]; for the total score, [Minimum: 0, Maximum: 12]; higher scores indicate greater support).
Measured: Change from enrolment (baseline) to six-weeks
Postpartum anxiety
Postpartum Specific Anxiety Scale (Minimum: 51, Maximum: 204; Higher score indicates higher anxiety)
Measured: Change from enrolment (baseline) to six-weeks
Postpartum depression
Edinburgh Postnatal Depression Scale (Minimum: 0, Maximum: 30; Higher score indicates higher depression)
Measured: Change from enrolment (baseline) to six-weeks
Self-Efficacy
Karitane Parenting Confidence Scale (Minimum: 0, Maximum: 45; Higher score indicates greater self-efficacy)
Measured: Change from six-weeks to six-months postpartum
Social Support
Multidimensional Scale of Perceived Social Support (For the sub-scales of family, friends, and significant other [Minimum: 0, Maximum: 4]; for the total score, [Minimum: 0, Maximum: 12]; higher scores indicate greater support).
Measured: Change from six-weeks to six-months postpartum
Postpartum anxiety
Postpartum Specific Anxiety Scale (Minimum: 51, Maximum: 204; Higher score indicates higher anxiety)
Measured: Change from six-weeks to six-months postpartum
Postpartum depression
Edinburgh Postnatal Depression Scale (Minimum: 0, Maximum: 30; Higher score indicates higher depression)
Measured: Change from six-weeks to six-months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start5 Jan 2021
- Primary completion13 Jul 2021
- Study completion21 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Maternal DistressStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The current study is a 2-group parallel arm randomized controlled trial, stratified by parity.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Dalhousie University
- Responsible party
- Principal investigator, Justine Dol, Dalhousie University
- Investigators
- Justine Dol, MSc, Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730570
- Sponsor's protocol ID
- 1024984
- Acronym
- ECEM
- Status last verified
- Sep 2023
- First submitted
- 19 Jan 2021
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dol J, Aston M, McMillan D, Tomblin Murphy G, Campbell-Yeo M. Effectiveness of a Postpartum Text Message Program (Essential Coaching for Every Mother) on Maternal Psychosocial Outcomes: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Mar 25;10(3):e27138. doi: 10.2196/27138.
PubMed 33764309Dol J, Aston M, McMillan D, Tomblin Murphy G, Campbell-Yeo M. Participants' Perceptions of Essential Coaching for Every Mother-a Canadian Text Message-Based Postpartum Program: Process Evaluation of a Randomized Controlled Trial. JMIR Form Res. 2022 May 13;6(5):e36821. doi: 10.2196/36821.
PubMed 35559855Dol J, Tomblin Murphy G, Aston M, McMillan D, Campbell-Yeo M. Design, development and usability testing of Essential Coaching for Every Mother: A postnatal text message educational intervention. Women Birth. 2021 May;34(3):e228-e236. doi: 10.1016/j.wombi.2020.05.004. Epub 2020 May 29.
PubMed 32475782
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Essential Coaching for Every Mother: A Randomized Controlled Trial Evaluating an Text Message Postpartum Program for Mothers
- ClinicalTrials.gov ID
- NCT04730570
- Acronym / sponsor ID
- ECEM / 1024984
- Conditions
- Maternal Distress
- Keywords
- maternal self-efficacy, postpartum depression, postpartum anxiety, mobile health education, postpartum support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Collaborators
- Dalhousie University
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 13 Jul 2021 (actual)
- Study completion
- 21 Jan 2022 (actual)
- First posted
- 29 Jan 2021 (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-based program called Essential Coaching for Every Mother which sends daily text messages during the immediate six-week postnatal period. Essential Coaching for Every Mother consists of standardized text messages that provide evidence-based information that women should be aware of related to caring for their newborn and maternal mental health.
Detailed description
This is a 2-group parallel arm randomized controlled trial. Participants will be randomized into either the intervention or a control group, stratified by parity. No changes to in-person care will occur.
Mothers in the intervention group will receive daily text messages from enrollment after birth until six-weeks postpartum.
Mothers in the control group will receive no content messages.
Mothers will be recruited both antenatally and postnatally through social media and study posters. All recruitment and participant engagement will occur remotely via text message. Women who are 37+ weeks pregnant up to 10 days postpartum will be eligible to send a text to a study specific number and complete an eligibility screening. If determined eligible once they deliver, the participant will be randomized into the intervention or control group and they will be asked to complete an electronic consent form and the baseline survey. 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 only receive reminder texts to complete the follow-up surveys. Both groups will be asked to complete an online survey at enrolment, six-weeks and six-months postpartum.
The investigators aim to recruitment 140 participants in total, 70 per group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The current study is a 2-group parallel arm randomized controlled trial, stratified by parity.
| Arm | Type | Receives |
|---|---|---|
| Essential Coaching for Every Mother Intervention | Experimental | Behavioral: Essential Coaching for Every MotherWomen in the intervention arm will receive the Essential Coaching for Every Mother messages up to six-weeks postpartum. No changes in standard care. |
| Standard care | No intervention | –Women in the control group will receive no content messages. No changes in standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- be at least 37 weeks pregnant
- have daily access to a mobile phone with text message capabilities
- are over 18 years of age
- speak and read English
- live in Nova Scotia, Canada.
Key exclusion criteria (5 listed)
- newborn 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 or withdraw to participate
- participated in Phase I of this project.
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 MotherEssential Coaching for Every Mother consists of 53 standardized text messages that provide evidence-based information that women should be aware of related to caring for their newborn and maternal mental health. Messages are personalized with the name of the child. Messages sent from birth to six-weeks postpartum, with two messages sent per day in the first two weeks and a daily message for weeks 3-6. The following topics covered in Essential Coaching for Every Mother include anxiety, depression, maternal self-care, postnatal follow-up, breastfeeding or formula feeding, infant concerns, cord care, well-baby care, normal development, crying, and safe sleep. Women who receive the messages will be able to self-select breastfeeding or formula feeding messages. | Behavioural | Essential Coaching for Every Mother Intervention |
Primary outcome
Self Efficacy
Time frame: Change from enrolment (baseline) to six-weeks
Karitane Parenting Confidence Scale (Minimum: 0, Maximum: 45; Higher score indicates greater self-efficacy)
7 secondary outcomes
Social support
Time frame: Change from enrolment (baseline) to six-weeks
Postpartum anxiety
Time frame: Change from enrolment (baseline) to six-weeks
Postpartum depression
Time frame: Change from enrolment (baseline) to six-weeks
Self-Efficacy
Time frame: Change from six-weeks to six-months postpartum
Social Support
Time frame: Change from six-weeks to six-months postpartum
Postpartum anxiety
Time frame: Change from six-weeks to six-months postpartum
Postpartum depression
Time frame: Change from six-weeks to six-months postpartum
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 25 Sep 2023.
- Background: PubMed 33764309Dol J, Aston M, McMillan D, Tomblin Murphy G, Campbell-Yeo M. Effectiveness of a Postpartum Text Message Program (Essential Coaching for Every Mother) on Maternal Psychosocial Outcomes: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Mar 25;10(3):e27138. doi: 10.2196/27138.
- Background: PubMed 35559855Dol J, Aston M, McMillan D, Tomblin Murphy G, Campbell-Yeo M. Participants' Perceptions of Essential Coaching for Every Mother-a Canadian Text Message-Based Postpartum Program: Process Evaluation of a Randomized Controlled Trial. JMIR Form Res. 2022 May 13;6(5):e36821. doi: 10.2196/36821.
- Results publication: PubMed 32475782Dol J, Tomblin Murphy G, Aston M, McMillan D, Campbell-Yeo M. Design, development and usability testing of Essential Coaching for Every Mother: A postnatal text message educational intervention. Women Birth. 2021 May;34(3):e228-e236. doi: 10.1016/j.wombi.2020.05.004. Epub 2020 May 29.
- 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.
Justine Dol, MSc principal investigator
Dalhousie University
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 Maternal Distress, run by IWK Health Centre at 1 site in Canada.
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 12 inclusion and 5 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 25 Sep 2023. 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 Canada. 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?
Self Efficacy (time frame: Change from enrolment (baseline) to six-weeks). 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 NCT04730570, which also lists 3 linked publications.
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 25 Sep 2023.