Essential Coaching for Every Mother: A Randomized Controlled Trial Evaluating an Text Message Postpartum Program for Mothers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- IWK Health Centre
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Self Efficacy
Study Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Care Provider, Outcomes Assessor)
Masking Description
Blinding is not possible for participants and thus participants will be informed of their group allocation.
To minimize personnel blinding related to data collection, no hospital staff (nurse midwives, physicians, other healthcare providers) are required to be aware of participant's involvement in the study. This is possible as Essential Coaching for Every Mother is sent to the participant's personal cell phone with no intervention occurring in person.
The PI will be aware of participant allocation and will be responsible for collecting data but will not be involved in the randomization procedure which occurs directly in the TextIt platform. Additionally, there is no interaction with the participants from the PI or anyone on the research team as everything occurs remotely via a previously set up process, reducing any risk of influencing participant response and influencing outcome assessment.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Essential Coaching for Every Mother Intervention
Women in the intervention arm will receive the Essential Coaching for Every Mother messages up to six-weeks postpartum. No changes in standard care.
Intervention: Essential Coaching for Every Mother (Behavioral)
Standard care
Women in the control group will receive no content messages. No changes in standard care.
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Postpartum depression(Change from six-weeks to six-months postpartum)
- Social support(Change from enrolment (baseline) to six-weeks)
- Postpartum anxiety(Change from six-weeks to six-months postpartum)
- Self-Efficacy(Change from six-weeks to six-months postpartum)
- Social Support(Change from six-weeks to six-months postpartum)
- Postpartum anxiety(Change from enrolment (baseline) to six-weeks)
- Postpartum depression(Change from enrolment (baseline) to six-weeks)
Investigators
Justine Dol
Principal Investigator
Dalhousie University