Essential Coaching for Every Mother, a Postpartum Text Message Program for Canadian Mothers

Maternal Distress Clinical Trial

— ECEM  

Official title:

Essential Coaching for Every Mother: A Randomized Controlled Trial Evaluating an Text Message Postpartum Program for Mothers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04730570
• Other study ID #: 1024984
• Status: Completed
• Phase: N/A
• Start date: January 5, 2021
• Est. completion date: January 21, 2022

Study information

• Verified date: September 2023
• Source: IWK Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 21, 2022
• Est. primary completion date: July 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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.

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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Maternal Distress

Intervention

Behavioral:
• Essential Coaching for Every Mother
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.

Locations

Country	Name	City	State
Canada	IWK Health	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
IWK Health Centre	Dalhousie University

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View Citation

Dol 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. — View Citation

Dol 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Implementation extent (Reach)	What was the reach (i.e., enrolment rate)?	Through study completion, an average of 1 year
Other	Implementation extent (completion)	What was the completion rate (e.g., withdrawal rate)?	Through study completion, an average of 6 weeks
Other	Implementation extent (dose)	What was the dose received (i.e., number of messages received)?	Through study completion, an average of 6 weeks
Other	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]	6-weeks postpartum
Primary	Self Efficacy	Karitane Parenting Confidence Scale (Minimum: 0, Maximum: 45; Higher score indicates greater self-efficacy)	Change from enrolment (baseline) to six-weeks
Secondary	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).	Change from enrolment (baseline) to six-weeks
Secondary	Postpartum anxiety	Postpartum Specific Anxiety Scale (Minimum: 51, Maximum: 204; Higher score indicates higher anxiety)	Change from enrolment (baseline) to six-weeks
Secondary	Postpartum depression	Edinburgh Postnatal Depression Scale (Minimum: 0, Maximum: 30; Higher score indicates higher depression)	Change from enrolment (baseline) to six-weeks
Secondary	Self-Efficacy	Karitane Parenting Confidence Scale (Minimum: 0, Maximum: 45; Higher score indicates greater self-efficacy)	Change from six-weeks to six-months postpartum
Secondary	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).	Change from six-weeks to six-months postpartum
Secondary	Postpartum anxiety	Postpartum Specific Anxiety Scale (Minimum: 51, Maximum: 204; Higher score indicates higher anxiety)	Change from six-weeks to six-months postpartum
Secondary	Postpartum depression	Edinburgh Postnatal Depression Scale (Minimum: 0, Maximum: 30; Higher score indicates higher depression)	Change from six-weeks to six-months postpartum