Helpline Pilot Factorial Trial
ConditionHeavy Drinking
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorThe National Center on Addiction and Substance Abuse at Columbia University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Standard Helpline (SH)
- Motivational Interviewing (MI)
- Coping Skills Training (CST)
- Automated Text Messaging (ATM)
Treatment groups
120 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Locations
Sponsors and collaborators
Source ClinicalTrials.gov