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Helpline Pilot Factorial Trial
Sponsor: The National Center on Addiction and Substance Abuse at Columbia University
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 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.
Official title: Helpline Delivery of Brief Interventions for Postpartum Heavy Episodic Drinking
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-12-01
Completion Date
2027-07-31
Last Updated
2025-01-15
Healthy Volunteers
Yes
Conditions
Interventions
Standard Helpline (SH)
One digital helpline session that includes assessment, psychoeducation, and links to resources. Participants are also offered ongoing asynchronous digital support from the helpline.
Motivational Interviewing (MI)
One digital helpline session that includes a structured motivational interviewing brief intervention.
Coping Skills Training (CST)
One digital helpline session that includes a structured cognitive coping skills brief intervention.
Automated Text Messaging (ATM)
Automated text messages are sent daily for 4 weeks.