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Search / Trial NCT06591026

Trial Information

Current as of July 22, 2025

Not yet recruiting

Keywords

ClinConnect Summary

The Helpline Pilot Factorial Trial is a research study designed to explore ways to help women who are heavy drinkers after giving birth. The trial will test a few different support options to see which ones are most effective at motivating women to change their drinking habits and improve their self-confidence when it comes to managing alcohol. It will involve 120 postpartum mothers, who will be randomly assigned to different groups to receive various combinations of support, including motivational interviewing, coping skills training, and automated messaging, alongside a standard helpline.

To be eligible for this study, participants must be women aged 18 to 45 who have given birth within the last four weeks and live in the United States. They should also be able to read and speak English, own a phone that can receive text messages, and show a certain level of alcohol risk based on a screening tool. Those who qualify will have the opportunity to receive personalized support to help them with their drinking habits, and their experiences will help researchers understand which methods are most effective for new mothers. This study is not yet recruiting participants, but it aims to gather important information that could lead to better support for women struggling with alcohol use after childbirth.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Resides full-time in the United States
  • Age 18-45 years
  • Gave birth to an infant within the prior 4 weeks
  • Speaks and reads English
  • Owns a text-enabled cell-phone
  • Receives a score of 2 or more on the T-ACE alcohol risk screener
  • Reports ONE of the following: (a) drinking weekly or more often in the prior month; or (b) having 4 or more standard drinks at one time at least monthly in the 12 months prior to becoming pregnant.
  • Exclusion Criteria:
  • Resides outside of the United States
  • Age under 18 years or over 45 years
  • Did not give birth to an infant within the prior 4 weeks
  • Cannot speak and read English
  • Does not own a text-enabled cell-phone
  • Does not receive a score of at least 2 on the T-ACE alcohol risk screener
  • Does not report either drinking weekly or more often in the past month or having 4 or more standard drinks at least monthly in the 12 months prior to becoming pregnant
  • Scores greater than 4 on the AUDIT-C, indicating an alcohol use disorder

About The National Center On Addiction And Substance Abuse At Columbia University

The National Center on Addiction and Substance Abuse at Columbia University (CASAColumbia) is a leading research organization dedicated to advancing the understanding and treatment of addiction and substance use disorders. By integrating interdisciplinary research, education, and policy initiatives, CASAColumbia aims to develop evidence-based solutions that address the complexities of addiction. The center collaborates with a diverse range of stakeholders, including academic institutions, healthcare providers, and government agencies, to promote innovative clinical trials and interventions that enhance prevention, treatment, and recovery efforts across populations. Through its commitment to scientific excellence and public health advocacy, CASAColumbia plays a pivotal role in shaping effective strategies to combat addiction and improve the lives of individuals and families affected by substance use.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported