BabySTEPs: Supportive Texts to Empower Parents

NCT04719390 | Completed Results DMC

• 2 other identifiers: BabySTEPsR34AA028407
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Drinking

Keywords

Text messaging

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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.

Study Arms (1)

Text Messaging Intervention

EXPERIMENTAL

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

Interventions

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.

Text Messaging Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The National Center on Addiction and Substance Abuse at Columbia University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Partnership to End Addiction

New York, New York, 10017, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Results Point of Contact

• Title: Dr. Sarah Dauber
• Organization: Partnership to End Addiction

sdauber@toendaddiction.org

212-841-5270

Study Officials

• Sarah Dauber, PhD

  Partnership to End Addiction (formerly CASAColumbia)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Micro-Randomized Trial (MRT)

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: January 22, 2021
• Study Start: November 13, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: January 29, 2025
• Results First Posted: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)