Status:
NOT_YET_RECRUITING
Helpline Pilot Factorial Trial
Lead Sponsor:
The National Center on Addiction and Substance Abuse at Columbia University
Conditions:
Heavy Drinking
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06591026
Start Date
December 1 2025
End Date
July 31 2027
Last Update
January 15 2025
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