BabySTEPs: Supportive Texts Empowering Parents

Not Applicable

Completed

Lead Sponsor: The National Center on Addiction and Substance Abuse at Columbia University

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Maternal Message	Maternal Message	Randomized at daily time point to receive a maternal-focused message. Randomization probability for this arm is .40.
Drinking Message	Drinking Message	Randomized at daily time point to receive a drinking-focused message. Randomization probability for this arm is .40.

Primary Outcome Measures

Name	Time	Method
MRT Feasibility	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Maternal Self Efficacy	Assessed at each proximal outcome survey, twice per day for 28 days, regarding the next hour.	At each proximal outcome survey, participants rated their confidence in their ability to meet their baby's needs over the next hour on a scale of 1 (not at all confident) to 7 (extremely confident). Higher numbers indicated greater maternal self-efficacy.
Drinking Self-Efficacy	Assessed at each proximal outcome survey, twice per day for 28 days, regarding the next hour.	At each proximal outcome survey, participants rated their confidence in their ability to avoid drinking alcohol in the next hour on a scale of 1 (not at all confident) to 7 (extremely confident). Higher scores indicated higher drinking self-efficacy.
Motivation	Assessed at each proximal outcome survey, twice a day for 28 days, regarding the next hour.	At each proximal outcome survey, participants were asked to rate how committed they are to not drink alcohol in the next hour on a scale of 1 (not at all committed) to 7 (extremely committed). Higher scores indicate higher motivation to avoid alcohol.
Urge to Drink	Assessed at each proximal outcome survey, twice a day for 28 days.	At each proximal outcome survey, participants rated the extent of their urge to drink "right now" on a scale from 1 (very low) to 7 (very high). Higher scores indicate higher urge to drink alcohol.