BabySTEPs: Supportive Texts Empowering Parents

Alcohol Drinking Clinical Trial

Official title:

BabySTEPs: Supportive Texts Empowering Parents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04719390
• Other study ID #: BabySTEPs
• Secondary ID: R34AA028407
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: November 2023
• Source: The National Center on Addiction and Substance Abuse at Columbia University
• Contact: Sarah Dauber, PhD
• Phone: 212-841-5270
• Email: sdauber[@]toendaddiction.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking

Intervention

Behavioral:
• TMI Component
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.

Locations

Country	Name	City	State
United States	Partnership to End Addiction	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
The National Center on Addiction and Substance Abuse at Columbia University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risky drinking	Change in alcohol use measured using the Timeline Follow Back Interview	1 month post intervention completion
Secondary	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
Secondary	Parenting Stress	Assessed using the Parenting Stress Index-Short Form- higher scores indicate higher levels of parenting stress	1 month post intervention completion
Secondary	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
Secondary	Treatment utilization	Assessed using the Treatment Services Review	1 month post intervention completion