Alcohol Drinking
Conditions
Keywords
Text messaging
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.
Interventions
BEHAVIORALText 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.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
The National Center on Addiction and Substance Abuse at Columbia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Micro-Randomized Trial (MRT)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MRT Feasibility | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Self Efficacy | 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. |
| Urge to Drink | 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. |
| Drinking Self-Efficacy | 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. |
| Motivation | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 65 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Experimental: Text Messaging Intervention |
|---|---|
| Age, Continuous | 32.26 years STANDARD_DEVIATION 6.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants |
| Race (NIH/OMB) More than one race | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 37 Participants |
| Region of Enrollment United States | 65 participants |
| Sex: Female, Male Female | 65 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 65 |
| other Total, other adverse events | 0 / 65 |
| serious Total, serious adverse events | 0 / 65 |
Outcome results
Primary
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Text Messaging Intervention | Alcohol Use | 16 proximal outcome surveys |
| Intervention Message (Drinking and Maternal Combined) | Alcohol Use | 58 proximal outcome surveys |
| Maternal Focused Message | Alcohol Use | 31 proximal outcome surveys |
| Drinking Focused Message | Alcohol Use | 27 proximal outcome surveys |
Primary
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.
Time frame: Assessed on the final day of the 28-day MRT.
Population: All participants who completed the acceptability survey are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Text Messaging Intervention | MRT Acceptability | 2.31 score on a scale | Standard Deviation 1.53 |
Primary
MRT Feasibility
Proportion of EMA surveys completed out of total delivered.
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.
Population: All participants who completed the study were included in the analysis of MRT feasibility.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Text Messaging Intervention | MRT Feasibility | 77.05 percentage of surveys completed |
Secondary
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.
Time frame: Assessed at each proximal outcome survey, twice per day for 28 days, regarding the next hour.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Text Messaging Intervention | Drinking Self-Efficacy | 6.26 score on a scale | Standard Deviation 1.34 |
| Intervention Message (Drinking and Maternal Combined) | Drinking Self-Efficacy | 6.37 score on a scale | Standard Deviation 1.24 |
| Maternal Focused Message | Drinking Self-Efficacy | 6.35 score on a scale | Standard Deviation 1.24 |
| Drinking Focused Message | Drinking Self-Efficacy | 6.39 score on a scale | Standard Deviation 1.24 |
Secondary
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.
Time frame: Assessed at each proximal outcome survey, twice per day for 28 days, regarding the next hour.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Text Messaging Intervention | Maternal Self Efficacy | 6.54 score on a scale | Standard Deviation 0.93 |
| Intervention Message (Drinking and Maternal Combined) | Maternal Self Efficacy | 6.57 score on a scale | Standard Deviation 0.87 |
| Maternal Focused Message | Maternal Self Efficacy | 6.54 score on a scale | Standard Deviation 0.89 |
| Drinking Focused Message | Maternal Self Efficacy | 6.61 score on a scale | Standard Deviation 0.85 |
Secondary
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.
Time frame: Assessed at each proximal outcome survey, twice a day for 28 days, regarding the next hour.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Text Messaging Intervention | Motivation | 6.13 score on a scale | Standard Deviation 1.52 |
| Intervention Message (Drinking and Maternal Combined) | Motivation | 6.21 score on a scale | Standard Deviation 1.42 |
| Maternal Focused Message | Motivation | 6.21 score on a scale | Standard Deviation 1.39 |
| Drinking Focused Message | Motivation | 6.20 score on a scale | Standard Deviation 1.45 |
Secondary
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.
Time frame: Assessed at each proximal outcome survey, twice a day for 28 days.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Text Messaging Intervention | Urge to Drink | 1.94 score on a scale | Standard Deviation 1.37 |
| Intervention Message (Drinking and Maternal Combined) | Urge to Drink | 1.92 score on a scale | Standard Deviation 1.31 |
| Maternal Focused Message | Urge to Drink | 1.96 score on a scale | Standard Deviation 1.34 |
| Drinking Focused Message | Urge to Drink | 1.88 score on a scale | Standard Deviation 1.29 |