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| ID | Type | Description | Link |
|---|---|---|---|
| R34AA028407 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text Message | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| MRT Feasibility | Proportion of EMA surveys completed out of total delivered. | 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. | 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. | Assessed at each proximal outcome survey, twice per day for 28 days. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed at each proximal outcome survey, twice per day for 28 days, regarding the next hour. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Dauber, PhD | Partnership to End Addiction (formerly CASAColumbia) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Partnership to End Addiction | New York | New York | 10017 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
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| Overall Study |
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We did not include the one participant who withdrew from the study in any analyses since she withdrew almost immediately after enrolling.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | MRT Feasibility | Proportion of EMA surveys completed out of total delivered. | All participants who completed the study were included in the analysis of MRT feasibility. | Posted | Number | percentage of surveys completed | Surveys were delivered 4 times per day (2 EMA, 2 proximal outcome surveys) on each of the 28 days of the intervention period. |
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Adverse events were collected during the entire 28 day MRT period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sarah Dauber | Partnership to End Addiction | 212-841-5270 | sdauber@toendaddiction.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 24, 2023 | Dec 3, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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Micro-Randomized Trial (MRT)
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| 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. | 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. | 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. | Assessed at each proximal outcome survey, twice a day for 28 days. |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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. | All participants who completed the acceptability survey are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Assessed on the final day of the 28-day MRT. |
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| 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. | All 65 participants are represented in each condition as each participant is randomized multiple times per day. | Posted | Number | proximal outcome surveys | Assessed at each proximal outcome survey, twice per day for 28 days. | observations | observations |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed at each proximal outcome survey, twice per day for 28 days, regarding the next hour. | observations | observations |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed at each proximal outcome survey, twice per day for 28 days, regarding the next hour. | observations | observations |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed at each proximal outcome survey, twice a day for 28 days, regarding the next hour. | observations | observations |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed at each proximal outcome survey, twice a day for 28 days. | observations | observations |
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| 65 |
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| 65 |
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| 65 |
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