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BabySTEPs: Supportive Texts Empowering Parents

Primary Purpose

Alcohol Drinking

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TMI Component
Sponsored by
The National Center on Addiction and Substance Abuse at Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Drinking focused on measuring Text messaging

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Partnership to End AddictionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TMI Component On

TMI Component Off

Arm Description

Randomized at daily time point to ON, text messaging intervention gets sent to participant at that time

Randomized at daily time point to OFF, text messaging intervention does not get sent to participant at that time

Outcomes

Primary Outcome Measures

Risky drinking
Change in alcohol use measured using the Timeline Follow Back Interview

Secondary Outcome Measures

Depressive symptoms
Assessed using the Edinburgh Postnatal Depression Scale- scored from 0 to 30 with higher scores meaning higher likelihood of depression
Parenting Stress
Assessed using the Parenting Stress Index-Short Form- higher scores indicate higher levels of parenting stress
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.
Treatment utilization
Assessed using the Treatment Services Review

Full Information

First Posted
December 9, 2020
Last Updated
August 10, 2022
Sponsor
The National Center on Addiction and Substance Abuse at Columbia University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT04719390
Brief Title
BabySTEPs: Supportive Texts Empowering Parents
Official Title
BabySTEPs: Supportive Texts Empowering Parents
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The National Center on Addiction and Substance Abuse at Columbia University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking
Keywords
Text messaging

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Microrandomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TMI Component On
Arm Type
Experimental
Arm Description
Randomized at daily time point to ON, text messaging intervention gets sent to participant at that time
Arm Title
TMI Component Off
Arm Type
No Intervention
Arm Description
Randomized at daily time point to OFF, text messaging intervention does not get sent to participant at that time
Intervention Type
Behavioral
Intervention Name(s)
TMI Component
Intervention Description
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.
Primary Outcome Measure Information:
Title
Risky drinking
Description
Change in alcohol use measured using the Timeline Follow Back Interview
Time Frame
1 month post intervention completion
Secondary Outcome Measure Information:
Title
Depressive symptoms
Description
Assessed using the Edinburgh Postnatal Depression Scale- scored from 0 to 30 with higher scores meaning higher likelihood of depression
Time Frame
1 month post intervention completion
Title
Parenting Stress
Description
Assessed using the Parenting Stress Index-Short Form- higher scores indicate higher levels of parenting stress
Time Frame
1 month post intervention completion
Title
Maternal Self-Efficacy
Description
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.
Time Frame
1 month post intervention completion
Title
Treatment utilization
Description
Assessed using the Treatment Services Review
Time Frame
1 month post intervention completion

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Dauber, PhD
Phone
212-841-5270
Email
sdauber@toendaddiction.org
First Name & Middle Initial & Last Name or Official Title & Degree
Cori Hammond, MPH
Phone
212-841-5304
Email
chammond@toendaddiction.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Dauber, PhD
Organizational Affiliation
Partnership to End Addiction (formerly CASAColumbia)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Partnership to End Addiction
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexa Beacham
Email
abeacham@toendaddiction.org

12. IPD Sharing Statement

Plan to Share IPD
No

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BabySTEPs: Supportive Texts Empowering Parents

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