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Helpline Pilot Factorial Trial

RecruitingHealthy volunteers welcome

Helpline Delivery of Brief Interventions for Postpartum Heavy Episodic Drinking

Who can join

Ages 18 to 45 · Women · Healthy volunteers welcome

Full 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 study

The pilot factorial trial will (1) evaluate feasibility, acceptability, and fidelity of the intervention components (Aim 2.1), and (2) collect proof-of-concept data on the impact of the components on the proximal (motivation, self-efficacy, and self-regulation) and distal (quantity and frequency of HED) outcomes (Aim 2.2). Participants will include 120 postpartum mothers recruited from social media. The investigators will conduct a pilot 2X2X2 balanced full factorial trial, with 4 factors (1 constant, 3 randomized to 2 levels each) and 8 study conditions. The 4 factors will include: (1) Standard Helpline (constant); (2) Motivational Interviewing (yes vs. no); (3) Coping skills training (yes vs. no); (4) Automated messaging (yes vs. no). Participants will be randomly assigned to one of 8 study conditions, which will determine which combination of intervention components participants receive.

What is being tested

Sponsor: The National Center on Addiction and Substance Abuse at Columbia University · Participants: 120 · Started: Jun 1, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT06591026

Locations in the U.S.

New YorkPartnership to End Addiction, New York

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.