Alcohol DrinkingNCT04719390
BabySTEPs: Supportive Texts to Empower Parents
A study testing Text Message in people with Alcohol Drinking, run by The National Center on Addiction and Substance Abuse at Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Text Message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Partnership to End Addiction
New York, New York, 10017
About this study
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.
Read the 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
- Being tested
- Text Message
- Keywords
- Text messaging
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text MessageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Text Message |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRT Feasibility
Proportion of EMA surveys completed out of total delivered.
Measured: 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.
Measured: 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.
Measured: Assessed at each proximal outcome survey, twice per day for 28 days.
Secondary outcomes (4)
Maternal Self Efficacy
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.
Measured: Assessed at each proximal outcome survey, twice per day for 28 days, regarding the next hour.
Drinking Self-Efficacy
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.
Measured: Assessed at each proximal outcome survey, twice per day for 28 days, regarding the next hour.
Motivation
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.
Measured: Assessed at each proximal outcome survey, twice a day for 28 days, regarding the next hour.
Urge to Drink
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.
Measured: Assessed at each proximal outcome survey, twice a day for 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start13 Nov 2023
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Micro-Randomized Trial (MRT)
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- The National Center on Addiction and Substance Abuse at Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Sarah Dauber, PhD, Principal investigator, Partnership to End Addiction (formerly CASAColumbia)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719390
- Sponsor's protocol ID
- BabySTEPs
- Other IDs
- R34AA028407
- Status last verified
- Jan 2025
- First submitted
- 9 Dec 2020
- Last updated
- 29 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BabySTEPs: Supportive Texts to Empower Parents
- ClinicalTrials.gov ID
- NCT04719390
- Acronym / sponsor ID
- BabySTEPs
- Conditions
- Alcohol Drinking
- Keywords
- Text messaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- The National Center on Addiction and Substance Abuse at Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Posted 29 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Micro-Randomized Trial (MRT)
| Arm | Type | Receives |
|---|---|---|
| Text Messaging Intervention | Experimental | Behavioral: Text MessageAfter 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). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text 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. | Behavioural | Text Messaging Intervention |
Primary outcome
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.
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.
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.
4 secondary outcomes
Maternal Self Efficacy
Time frame: Assessed at each proximal outcome survey, twice per day for 28 days, regarding the next hour.
Drinking Self-Efficacy
Time frame: Assessed at each proximal outcome survey, twice per day for 28 days, regarding the next hour.
Motivation
Time frame: Assessed at each proximal outcome survey, twice a day for 28 days, regarding the next hour.
Urge to Drink
Time frame: Assessed at each proximal outcome survey, twice a day for 28 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Dauber, PhD principal investigator
Partnership to End Addiction (formerly CASAColumbia)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Message in people with Alcohol Drinking, run by The National Center on Addiction and Substance Abuse at Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.