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Helpline Pilot Factorial Trial

RecruitingNAAges 18 Years - 45 YearsFemaleThe National Center on Addiction and Substance Ab…
NCT06591026 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 recei

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📋 Eligibility rules (as published)
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
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What it tests

  • Standard Helpline (SH)
  • Motivational Interviewing (MI)
  • Coping Skills Training (CST)
  • Automated Text Messaging (ATM)
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Where

1 site
Partnership to End Addiction
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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