Clinical trial NCT04719390: BabySTEPs: Supportive Texts to Empower Parents
Official title: BabySTEPs: Supportive Texts to Empower Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Keywords: Text messaging
Lead sponsor: The National Center on Addiction and Substance Abuse at Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2021-01-22
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Micro-Randomized Trial (MRT)
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: MRT Feasibility
timeFrame: Surveys were delivered 4 times per day (2 EMA, 2 proximal outcome surveys) on each of the 28 days of the intervention period.
measure: MRT Acceptability
timeFrame: Assessed on the final day of the 28-day MRT.
measure: Alcohol Use
timeFrame: Assessed at each proximal outcome survey, twice per day for 28 days.
Secondary outcomes:
measure: Maternal Self Efficacy
timeFrame: Assessed at each proximal outcome survey, twice per day for 28 days, regarding the next hour.
measure: Drinking Self-Efficacy
timeFrame: Assessed at each proximal outcome survey, twice per day for 28 days, regarding the next hour.
measure: Motivation
timeFrame: Assessed at each proximal outcome survey, twice a day for 28 days, regarding the next hour.
measure: Urge to Drink
timeFrame: Assessed at each proximal outcome survey, twice a day for 28 days.
Other outcomes:
Locations:
city: New York
country: United States
facility: Partnership to End Addiction
state: New York
Study officials:
affiliation: Partnership to End Addiction (formerly CASAColumbia)
name: Sarah Dauber, PhD
role: PRINCIPAL_INVESTIGATOR
References: