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Completed

NCT Number: NCT04719390

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.

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Key information

Conditions

Alcohol Drinking Behavior Drinking Behavior

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Partnership to End Addiction

New York, 10017, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Text Message

Behavioral

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.

Primary outcomes

  1. MRT Feasibility

    Time frame: 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.

  2. MRT Acceptability

    Time frame: 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.

  3. Alcohol Use

    Time frame: 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 outcomes

  1. Maternal Self Efficacy

    Time frame: 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.

  2. Drinking Self-Efficacy

    Time frame: 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.

  3. Motivation

    Time frame: 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.

  4. Urge to Drink

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The National Center on Addiction and Substance Abuse at Columbia University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 22, 2021
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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