BabySTEPs: Supportive Texts to Empower Parents

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Drinking
• Intervention / Treatment: Behavioral: Text Message

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10017
      • Partnership to End Addiction

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Text Messaging Intervention; After each daily EMA survey, participants were micro-randomized to (1) receive a maternal-focused message (.40 probability); (2) receive a drinking-focused message (.40 probability) or (3) receive no message (.20 probability).

Behavioral: Text Message; Maternal-Focused Message: When randomized to receive a maternal-focused message, participants will receive a message that is focused on the transition to motherhood and the joys and challenges of caring for a newborn. Drinking-Focused Message: When randomized to receive a drinking-focused message, participants will receive a message that is focused on reducing alcohol use. All messages of both types are designed to map onto behavior change techniques that are empirically supported for alcohol use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRT Feasibility	Proportion of EMA surveys completed out of total delivered.	Surveys were delivered 4 times per day (2 EMA, 2 proximal outcome surveys) on each of the 28 days of the intervention period.
MRT Acceptability	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.	Assessed on the final day of the 28-day MRT.
Alcohol Use	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.	Assessed at each proximal outcome survey, twice per day for 28 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Self Efficacy	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.	Assessed at each proximal outcome survey, twice per day for 28 days, regarding the next hour.
Drinking Self-Efficacy	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.	Assessed at each proximal outcome survey, twice per day for 28 days, regarding the next hour.
Motivation	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.	Assessed at each proximal outcome survey, twice a day for 28 days, regarding the next hour.
Urge to Drink	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.	Assessed at each proximal outcome survey, twice a day for 28 days.

Collaborators and Investigators

• Sponsor: The National Center on Addiction and Substance Abuse at Columbia University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Sarah Dauber, PhD, Partnership to End Addiction (formerly CASAColumbia)

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2023
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: December 9, 2020
• First Submitted That Met QC Criteria: January 20, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Text messaging
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: BabySTEPs; R34AA028407 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No