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Helpline Pilot Factorial Trial

NCT06591026 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-01-15

No results posted yet for this study

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.

Conditions

  • Heavy Drinking

Interventions

BEHAVIORAL

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.

BEHAVIORAL

Motivational Interviewing (MI)

One digital helpline session that includes a structured motivational interviewing brief intervention.

BEHAVIORAL

Coping Skills Training (CST)

One digital helpline session that includes a structured cognitive coping skills brief intervention.

BEHAVIORAL

Automated Text Messaging (ATM)

Automated text messages are sent daily for 4 weeks.

Sponsors & Collaborators

  • The National Center on Addiction and Substance Abuse at Columbia University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2027-07-31
Completion
2027-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06591026 on ClinicalTrials.gov