BabySTEPs: Supportive Texts to Empower Parents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- MRT Feasibility
研究概览
简要总结
This study is a pilot micro-randomized trial (MRT) that aims to establish feasibility, acceptability, and preliminary proof-of-concept of a text messaging intervention for postpartum alcohol use.
详细描述
The pilot MRT is designed preliminary to assess feasibility and acceptability of the MRT design, as well as to compare acceptability and preliminary impact of two types of intervention messages in a sample of 65 postpartum mothers with histories of heavy episodic drinking.
The MRT was conducted using the Catalyst app, which was available for download on participants' personal smartphones. Participants completed ecological momentary assessment (EMA) surveys twice per day for 28 days. Following EMA completion, participants were randomized to receive a maternal-focused message (.40 probability), a drinking-focused message (.40 probability), or no message (.20 probability). If randomized to receive a message, participants would receive an intervention message that was selected at random from one of the 60 available messages in that condition, with each message having an equal probability of being selected. Following message receipt, participants were sent two questions asking whether the message was helpful (yes, no, not sure) and how the message made them feel (empowered, judged, understood, seen, confident, misunderstood, bad about myself, good, bad). Outcomes were assessed via EMA 15 minutes after delivery of the intervention message.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •adult women ages 18-45 years who gave birth to an infant that will remain in their care
- •English-speaking
- •own a text-enabled cell phone
- •report a score of 2 or higher on the T-ACE alcohol risk screener AND (a) drinking weekly or more often in the past month OR (b) having 4 or more standard drinks at least monthly in the 12 months prior to becoming pregnant.
排除标准
- •women age 46 years or older
- •women who did not recently give birth to an infant
- •women who gave birth to an infant but that infant is not in their care
- •individuals who do not speak English
- •women who report a score of less than 2 on the T-ACE alcohol risk screener
- •women who do not report either weekly or more drinking in the past month OR having 4 or more standard drinks at least monthly in the 12 months prior to becoming pregnant.
结局指标
主要结局
MRT Feasibility
时间窗: Surveys were delivered 4 times per day (2 EMA, 2 proximal outcome surveys) on each of the 28 days of the intervention period.
Proportion of EMA surveys completed out of total delivered.
MRT Acceptability
时间窗: Assessed on the final day of the 28-day MRT.
MRT acceptability was assessed via a 9-item scale assessing burden associated with the study. Cronbach's alpha in the sample was 0.88. Items were rated on a 1 to 7 scale, with higher scores reflecting higher burden. Scores on each item were averaged to create a total score ranging from 1 to 7. The average total score is reported.
Alcohol Use
时间窗: Assessed at each proximal outcome survey, twice per day for 28 days.
At each EMA survey/randomization decision point, participants were asked if they drank any alcohol in the prior hour (yes or no). At each proximal outcome survey (15 minutes after randomization), participants were asked if they drank any alcohol since their last survey (yes or no). The outcome is reported as the percent of participants who endorsed alcohol use on the proximal outcome survey, after randomization.
次要结局
- Maternal Self Efficacy(Assessed at each proximal outcome survey, twice per day for 28 days, regarding the next hour.)
- Drinking Self-Efficacy(Assessed at each proximal outcome survey, twice per day for 28 days, regarding the next hour.)
- Motivation(Assessed at each proximal outcome survey, twice a day for 28 days, regarding the next hour.)
- Urge to Drink(Assessed at each proximal outcome survey, twice a day for 28 days.)