BabySTEPs: Supportive Texts to Empower Parents

NCT ID: NCT04719390

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-13
• Study Completion Date: 2024-06-01

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.

Conditions

Alcohol Drinking

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Text Message

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

The National Center on Addiction and Substance Abuse at Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Dauber, PhD

Role: PRINCIPAL_INVESTIGATOR

Partnership to End Addiction (formerly CASAColumbia)

Locations

Partnership to End Addiction

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R34AA028407

Identifier Type: NIH

Identifier Source: secondary_id

View Link

BabySTEPs

Identifier Type: -

Identifier Source: org_study_id