Essential Coaching for Every Mother: A Randomized Controlled Trial Evaluating an Text Message Postpartum Program for Mothers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Self Efficacy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Self Efficacy
时间窗: Change from enrolment (baseline) to six-weeks
Karitane Parenting Confidence Scale (Minimum: 0, Maximum: 45; Higher score indicates greater self-efficacy)
次要结局
- 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 depression(Change from six-weeks to six-months postpartum)
研究者
Justine Dol
Principal Investigator
Dalhousie University