BabySTEPs: Supportive Texts Empowering Parents

Study Overview
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Brief Summary
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This R34 will develop a theory-driven, adaptive text messaging intervention (TMI) for risky drinking in postpartum women.

Detailed Description
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The investigators will conduct a pilot micro-randomized trial (MRT) with 50 postpartum women with the primary goal of demonstrating feasibility and acceptability of MRT methods and the secondary goal of providing proof-of-concept data on the impact of the text messaging intervention components on the proposed risk factors (stress, negative mood, self-efficacy) and the proximal (coping, motivation, and daily drinking) and distal outcomes (reduction in risky drinking).

Official Title
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BabySTEPs: Supportive Texts Empowering Parents

Conditions
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Alcohol Drinking

Intervention / Treatment
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* Behavioral: TMI Component


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Microrandomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TMI Component On<br>Randomized at daily time point to ON, text messaging intervention gets sent to participant at that time | Behavioral: TMI Component<br>* The text messaging intervention will include 2 motivational interviewing components and 2 cognitive behavioral therapy components, targeting motivation and coping, and taking a harm reduction approach.<br>|
| No Intervention: TMI Component Off<br>Randomized at daily time point to OFF, text messaging intervention does not get sent to participant at that time | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risky drinking | Change in alcohol use measured using the Timeline Follow Back Interview | 1 month post intervention completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms | Assessed using the Edinburgh Postnatal Depression Scale- scored from 0 to 30 with higher scores meaning higher likelihood of depression | 1 month post intervention completion | 
| Parenting Stress | Assessed using the Parenting Stress Index-Short Form- higher scores indicate higher levels of parenting stress | 1 month post intervention completion | 
| Maternal Self-Efficacy | Assessed using the Perceived Maternal Parental Self-Efficacy Tool. Total scores can range from 20 to 80; a higher score indicates a higher level of maternal self-efficacy. | 1 month post intervention completion | 
| Treatment utilization | Assessed using the Treatment Services Review | 1 month post intervention completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Text messaging