An interventional study of Essential Coaching for Every Mother in Maternal Distress, sponsored by IWK Health Centre. Completed at 1 site in Canada. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-25.
Sponsored by IWK Health Centre · Not applicable, Interventional, and Prevention
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.
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.
536 studies on the registry are indexed under Depression, Postpartum; 126 are open to participants now.
This study's enrollment of 150 is above the median of 105 across 430 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →IWK Health Centre is the lead sponsor of 86 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To enroll antenatally, participants must:
To enroll postnatally, participants must:
Exclusion Criteria:
Women in the intervention arm will receive the Essential Coaching for Every Mother messages up to six-weeks postpartum. No changes in standard care.
Behavioral: Essential Coaching for Every Mother
Women in the control group will receive no content messages. No changes in standard care.
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.
Self Efficacy
Karitane Parenting Confidence Scale (Minimum: 0, Maximum: 45; Higher score indicates greater self-efficacy)
Time frame: Change from enrolment (baseline) to six-weeks
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).
Time frame: Change from enrolment (baseline) to six-weeks
Postpartum anxiety
Postpartum Specific Anxiety Scale (Minimum: 51, Maximum: 204; Higher score indicates higher anxiety)
Time frame: Change from enrolment (baseline) to six-weeks
Postpartum depression
Edinburgh Postnatal Depression Scale (Minimum: 0, Maximum: 30; Higher score indicates higher depression)
Time frame: Change from enrolment (baseline) to six-weeks
Self-Efficacy
Karitane Parenting Confidence Scale (Minimum: 0, Maximum: 45; Higher score indicates greater self-efficacy)
Time frame: 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).
Time frame: Change from six-weeks to six-months postpartum
Postpartum anxiety
Postpartum Specific Anxiety Scale (Minimum: 51, Maximum: 204; Higher score indicates higher anxiety)
Time frame: Change from six-weeks to six-months postpartum
Postpartum depression
Edinburgh Postnatal Depression Scale (Minimum: 0, Maximum: 30; Higher score indicates higher depression)
Time frame: Change from six-weeks to six-months postpartum
Implementation extent (Reach)
What was the reach (i.e., enrolment rate)?
Time frame: Through study completion, an average of 1 year
Implementation extent (completion)
What was the completion rate (e.g., withdrawal rate)?
Time frame: Through study completion, an average of 6 weeks
Implementation extent (dose)
What was the dose received (i.e., number of messages received)?
Time frame: Through study completion, an average of 6 weeks
Implementation quality
Qualitative feedback on program: * What did you like most about Essential Coaching for Every Mother? \[open ended\] * What did you like least about Essential Coaching for Every Mother? \[open ended\] * Did you face any barriers with acting on the information received from Essential Coaching for Every Mother at home (e.g., geographical impacts, cellular access, health seeking opportunities)? If yes, please describe. \[open ended\] * How can Essential Coaching for Every Mother be improved further? \[open ended\]
Time frame: 6-weeks postpartum
Plan to share: No
Ran from Jan 2021 to primary completion in Jul 2021, 6 months.
Of 241 non-industry interventional studies with no phase under Depression, Postpartum, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's 6 months is below that.
Counting every sponsor, half of 247 studies reached it within 23 months; a quarter within 11 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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IWK Health Centre