Not yet recruiting NCT06591026

Helpline Pilot Factorial Trial

Phase I Interventional Heavy Drinking

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Standard Helpline (SH), Motivational Interviewing (MI), Coping Skills Training (CST), Automated Text Messaging (ATM).
Who it may be relevant to: Registry conditions: Heavy Drinking. Basic parameters: 18 years — 45 years · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Helpline Delivery of Brief Interventions for Postpartum Heavy Episodic Drinking

Overview

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 the proximal (motivation, self-efficacy, and self-regulation) and distal (quantity and frequency of HED) outcomes (Aim 2.2). In keeping with the goals of the R34 mechanism, the emphasis will be on feasibility evaluation and not on hypothesis testing, with a goal of obtaining preliminary information about implementation feasibility and effect sizes of the intervention components to inform a fully-powered optimization trial in a future R01. Thus, investigators will examine main and interactive effects of the intervention components in an exploratory manner to inform refining the components for further testing in a future study. 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. The study will last for 24 weeks. Following informed consent, participants will complete a baseline assessment and randomization, at which point participants will be enrolled. The active intervention period will begin in Week 2, with the number of scheduled sessions varying by condition. Participants will complete a post-intervention assessment and qualitative interview after the final intervention contact (varying by condition), and follow-up assessments at 3- and 6-months post-baseline.

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.

Primary outcome measures

Heavy episodic drinking [Time frame: 3-month follow-up; 6-month follow-up]

Secondary outcome measures (4)

Motivation to avoid alcohol [Time frame: 3-month follow-up; 6-month follow-up]
Drinking self-efficacy [Time frame: 3-month follow-up; 6-month follow-up]
Maternal self-efficacy [Time frame: 3-month follow-up; 6-month follow-up]
Self-regulation [Time frame: 3-month follow-up; 6-month follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation: Randomized
Model: Factorial
Masking: Single blind
Primary purpose: Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06591026 · Helpline R34

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗