Helpline Pilot Factorial Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2027-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heavy Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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SH Only

Participants receive standard helpline component only

Group Type ACTIVE_COMPARATOR

Standard Helpline (SH)

Intervention Type BEHAVIORAL

One digital helpline session that includes assessment, psychoeducation, and links to resources. Participants are also offered ongoing asynchronous digital support from the helpline.

SH+CST

Participants receive the standard helpline component and the cognitive coping skills component.

Group Type EXPERIMENTAL

Standard Helpline (SH)

Intervention Type BEHAVIORAL

One digital helpline session that includes assessment, psychoeducation, and links to resources. Participants are also offered ongoing asynchronous digital support from the helpline.

Coping Skills Training (CST)

Intervention Type BEHAVIORAL

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

SH+ATM

Participants receive the standard helpline component and the automated messaging component.

Group Type EXPERIMENTAL

Standard Helpline (SH)

Intervention Type BEHAVIORAL

One digital helpline session that includes assessment, psychoeducation, and links to resources. Participants are also offered ongoing asynchronous digital support from the helpline.

Automated Text Messaging (ATM)

Intervention Type BEHAVIORAL

Automated text messages are sent daily for 4 weeks.

SH+CST+ATM

Participants receive the standard helpline component, the cognitive coping skills component, and the automated messaging component.

Group Type EXPERIMENTAL

Standard Helpline (SH)

Intervention Type BEHAVIORAL

One digital helpline session that includes assessment, psychoeducation, and links to resources. Participants are also offered ongoing asynchronous digital support from the helpline.

Coping Skills Training (CST)

Intervention Type BEHAVIORAL

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

Automated Text Messaging (ATM)

Intervention Type BEHAVIORAL

Automated text messages are sent daily for 4 weeks.

SH+MI

Participants receive the standard helpline component and the motivational interviewing component.

Group Type EXPERIMENTAL

Standard Helpline (SH)

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

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

SH+MI+CST

Participants receive the standard helpline component, the motivational interviewing component, and the cognitive coping skills component.

Group Type EXPERIMENTAL

Standard Helpline (SH)

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

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

Coping Skills Training (CST)

Intervention Type BEHAVIORAL

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

SH+MI+ATM

Participants receive the standard helpline component, the motivational interviewing component, and the automated messaging component.

Group Type EXPERIMENTAL

Standard Helpline (SH)

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

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

Automated Text Messaging (ATM)

Intervention Type BEHAVIORAL

Automated text messages are sent daily for 4 weeks.

SH+MI+CST+ATM

Participants receive the standard helpline component, the motivational interviewing component, the coping skills component, and the automated messaging component.

Group Type EXPERIMENTAL

Standard Helpline (SH)

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

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

Coping Skills Training (CST)

Intervention Type BEHAVIORAL

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

Automated Text Messaging (ATM)

Intervention Type BEHAVIORAL

Automated text messages are sent daily for 4 weeks.

Interventions

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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.

Intervention Type BEHAVIORAL

Motivational Interviewing (MI)

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

Intervention Type BEHAVIORAL

Coping Skills Training (CST)

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

Intervention Type BEHAVIORAL

Automated Text Messaging (ATM)

Automated text messages are sent daily for 4 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes