Clinical Trials Directory

Trials / Completed

CompletedNCT04719390

BabySTEPs: Supportive Texts to Empower Parents

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
66 (actual)
Sponsor
The National Center on Addiction and Substance Abuse at Columbia University · Academic / Other
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
BEHAVIORALText MessageMaternal-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.

Timeline

Start date
2023-11-13
Primary completion
2024-06-01
Completion
2024-06-01
First posted
2021-01-22
Last updated
2025-01-29
Results posted
2025-01-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04719390. Inclusion in this directory is not an endorsement.