Trial Outcomes & Findings for BabySTEPs: Supportive Texts to Empower Parents (NCT NCT04719390)
NCT ID: NCT04719390
Last Updated: 2025-01-29
Results Overview
Proportion of EMA surveys completed out of total delivered.
COMPLETED
NA
66 participants
Surveys were delivered 4 times per day (2 EMA, 2 proximal outcome surveys) on each of the 28 days of the intervention period.
2025-01-29
Participant Flow
We received 1408 valid eligibility screens, of which 1161 were complete. Of the 1161 completed eligibility screens, 771 participants met eligibility criteria for the study and 216 provided informed consent to participate. of the 216 participants who provided informed consent, 103 completed the baseline survey, 70 completed the training, and 66 enrolled in the study. One participant withdrew from the study shortly after enrolling, leaving a total sample size of 65.
Participant milestones
| Measure |
Experimental: Text Messaging Intervention
The intervention consisted of text messages that were either maternal-focused (focused on the transition to motherhood) or drinking-focused (focused on reducing alcohol use). Each EMA survey (received twice daily) served as an intervention decision point. At each decision point, participants were randomized by the Catalyst app to receive a maternal message (.40 probability), a drinking message (.40 probability) or no message (.20 probability).
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|---|---|
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Overall Study
STARTED
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66
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Overall Study
COMPLETED
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65
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Experimental: Text Messaging Intervention
The intervention consisted of text messages that were either maternal-focused (focused on the transition to motherhood) or drinking-focused (focused on reducing alcohol use). Each EMA survey (received twice daily) served as an intervention decision point. At each decision point, participants were randomized by the Catalyst app to receive a maternal message (.40 probability), a drinking message (.40 probability) or no message (.20 probability).
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|---|---|
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
BabySTEPs: Supportive Texts to Empower Parents
Baseline characteristics by cohort
| Measure |
Experimental: Text Messaging Intervention
n=65 Participants
The intervention consisted of text messages that were either maternal-focused (focused on the transition to motherhood) or drinking-focused (focused on reducing alcohol use). Each EMA survey (received twice daily) served as an intervention decision point. At each decision point, participants were randomized by the Catalyst app to receive a maternal message (.40 probability), a drinking message (.40 probability) or no message (.20 probability).
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|---|---|
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Age, Continuous
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32.26 years
STANDARD_DEVIATION 6.20 • n=5 Participants
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Sex: Female, Male
Female
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65 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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6 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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59 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
American Indian or Alaska Native
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1 Participants
n=5 Participants
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|
Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Black or African American
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21 Participants
n=5 Participants
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|
Race (NIH/OMB)
White
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37 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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6 Participants
n=5 Participants
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|
Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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65 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Surveys were delivered 4 times per day (2 EMA, 2 proximal outcome surveys) on each of the 28 days of the intervention period.Population: All participants who completed the study were included in the analysis of MRT feasibility.
Proportion of EMA surveys completed out of total delivered.
Outcome measures
| Measure |
Experimental: Text Messaging Intervention
n=65 Participants
The intervention consisted of text messages that were either maternal-focused (focused on the transition to motherhood) or drinking-focused (focused on reducing alcohol use). Each EMA survey (received twice daily) served as an intervention decision point. At each decision point, participants were randomized by the Catalyst app to receive a maternal message (.40 probability), a drinking message (.40 probability) or no message (.20 probability).
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Intervention Message (Drinking and Maternal Combined)
Randomized to receive an intervention message--drinking and maternal focused messages combined.
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Maternal Focused Message
Randomized to receive a maternal focused message
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Drinking Focused Message
Randomized to receive a drinking focused message
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|---|---|---|---|---|
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MRT Feasibility
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77.05 percentage of surveys completed
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—
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—
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—
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PRIMARY outcome
Timeframe: Assessed on the final day of the 28-day MRT.Population: All participants who completed the acceptability survey are included in the analysis.
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.
Outcome measures
| Measure |
Experimental: Text Messaging Intervention
n=57 Participants
The intervention consisted of text messages that were either maternal-focused (focused on the transition to motherhood) or drinking-focused (focused on reducing alcohol use). Each EMA survey (received twice daily) served as an intervention decision point. At each decision point, participants were randomized by the Catalyst app to receive a maternal message (.40 probability), a drinking message (.40 probability) or no message (.20 probability).
|
Intervention Message (Drinking and Maternal Combined)
Randomized to receive an intervention message--drinking and maternal focused messages combined.
|
Maternal Focused Message
Randomized to receive a maternal focused message
|
Drinking Focused Message
Randomized to receive a drinking focused message
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|---|---|---|---|---|
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MRT Acceptability
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2.31 score on a scale
Standard Deviation 1.53
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—
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—
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—
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PRIMARY outcome
Timeframe: Assessed at each proximal outcome survey, twice per day for 28 days.Population: All 65 participants are represented in each condition as each participant is randomized multiple times per day.
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.
Outcome measures
| Measure |
Experimental: Text Messaging Intervention
n=411 observations
The intervention consisted of text messages that were either maternal-focused (focused on the transition to motherhood) or drinking-focused (focused on reducing alcohol use). Each EMA survey (received twice daily) served as an intervention decision point. At each decision point, participants were randomized by the Catalyst app to receive a maternal message (.40 probability), a drinking message (.40 probability) or no message (.20 probability).
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Intervention Message (Drinking and Maternal Combined)
n=1734 observations
Randomized to receive an intervention message--drinking and maternal focused messages combined.
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Maternal Focused Message
n=891 observations
Randomized to receive a maternal focused message
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Drinking Focused Message
n=843 observations
Randomized to receive a drinking focused message
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|---|---|---|---|---|
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Alcohol Use
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16 proximal outcome surveys
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58 proximal outcome surveys
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31 proximal outcome surveys
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27 proximal outcome surveys
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SECONDARY outcome
Timeframe: Assessed at each proximal outcome survey, twice per day for 28 days, regarding the next hour.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.
Outcome measures
| Measure |
Experimental: Text Messaging Intervention
n=390 observations
The intervention consisted of text messages that were either maternal-focused (focused on the transition to motherhood) or drinking-focused (focused on reducing alcohol use). Each EMA survey (received twice daily) served as an intervention decision point. At each decision point, participants were randomized by the Catalyst app to receive a maternal message (.40 probability), a drinking message (.40 probability) or no message (.20 probability).
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Intervention Message (Drinking and Maternal Combined)
n=1655 observations
Randomized to receive an intervention message--drinking and maternal focused messages combined.
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Maternal Focused Message
n=847 observations
Randomized to receive a maternal focused message
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Drinking Focused Message
n=808 observations
Randomized to receive a drinking focused message
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|---|---|---|---|---|
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Maternal Self Efficacy
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6.54 score on a scale
Standard Deviation 0.93
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6.57 score on a scale
Standard Deviation 0.87
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6.54 score on a scale
Standard Deviation 0.89
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6.61 score on a scale
Standard Deviation 0.85
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SECONDARY outcome
Timeframe: Assessed at each proximal outcome survey, twice per day for 28 days, regarding the next hour.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.
Outcome measures
| Measure |
Experimental: Text Messaging Intervention
n=414 observations
The intervention consisted of text messages that were either maternal-focused (focused on the transition to motherhood) or drinking-focused (focused on reducing alcohol use). Each EMA survey (received twice daily) served as an intervention decision point. At each decision point, participants were randomized by the Catalyst app to receive a maternal message (.40 probability), a drinking message (.40 probability) or no message (.20 probability).
|
Intervention Message (Drinking and Maternal Combined)
n=1742 observations
Randomized to receive an intervention message--drinking and maternal focused messages combined.
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Maternal Focused Message
n=895 observations
Randomized to receive a maternal focused message
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Drinking Focused Message
n=847 observations
Randomized to receive a drinking focused message
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|---|---|---|---|---|
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Drinking Self-Efficacy
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6.26 score on a scale
Standard Deviation 1.34
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6.37 score on a scale
Standard Deviation 1.24
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6.35 score on a scale
Standard Deviation 1.24
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6.39 score on a scale
Standard Deviation 1.24
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SECONDARY outcome
Timeframe: Assessed at each proximal outcome survey, twice a day for 28 days, regarding the next hour.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.
Outcome measures
| Measure |
Experimental: Text Messaging Intervention
n=414 observations
The intervention consisted of text messages that were either maternal-focused (focused on the transition to motherhood) or drinking-focused (focused on reducing alcohol use). Each EMA survey (received twice daily) served as an intervention decision point. At each decision point, participants were randomized by the Catalyst app to receive a maternal message (.40 probability), a drinking message (.40 probability) or no message (.20 probability).
|
Intervention Message (Drinking and Maternal Combined)
n=1743 observations
Randomized to receive an intervention message--drinking and maternal focused messages combined.
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Maternal Focused Message
n=896 observations
Randomized to receive a maternal focused message
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Drinking Focused Message
n=847 observations
Randomized to receive a drinking focused message
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|---|---|---|---|---|
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Motivation
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6.13 score on a scale
Standard Deviation 1.52
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6.21 score on a scale
Standard Deviation 1.42
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6.21 score on a scale
Standard Deviation 1.39
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6.20 score on a scale
Standard Deviation 1.45
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SECONDARY outcome
Timeframe: Assessed at each proximal outcome survey, twice a day for 28 days.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.
Outcome measures
| Measure |
Experimental: Text Messaging Intervention
n=413 observations
The intervention consisted of text messages that were either maternal-focused (focused on the transition to motherhood) or drinking-focused (focused on reducing alcohol use). Each EMA survey (received twice daily) served as an intervention decision point. At each decision point, participants were randomized by the Catalyst app to receive a maternal message (.40 probability), a drinking message (.40 probability) or no message (.20 probability).
|
Intervention Message (Drinking and Maternal Combined)
n=1734 observations
Randomized to receive an intervention message--drinking and maternal focused messages combined.
|
Maternal Focused Message
n=892 observations
Randomized to receive a maternal focused message
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Drinking Focused Message
n=842 observations
Randomized to receive a drinking focused message
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|---|---|---|---|---|
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Urge to Drink
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1.94 score on a scale
Standard Deviation 1.37
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1.92 score on a scale
Standard Deviation 1.31
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1.96 score on a scale
Standard Deviation 1.34
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1.88 score on a scale
Standard Deviation 1.29
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Adverse Events
Experimental: Text Messaging Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place