Helpline Pilot Factorial Trial

The National Center on Addiction and Substance Abuse at Columbia University

Status and phase: Not yet enrolling; Phase 1

Conditions: Heavy Drinking

Treatments: Behavioral: Standard Helpline (SH); Behavioral: Motivational Interviewing (MI); Behavioral: Coping Skills Training (CST); Behavioral: Automated Text Messaging (ATM)

Study type: Interventional

Funder types: Other

Identifiers

NCT06591026

Helpline R34

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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120 participants in 8 patient groups

SH Only

Active Comparator group

Description:

Participants receive standard helpline component only

Treatment:

Behavioral: Standard Helpline (SH)

SH+CST

Experimental group

Description:

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

Treatment:

Behavioral: Coping Skills Training (CST)

Behavioral: Standard Helpline (SH)

SH+ATM

Experimental group

Description:

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

Treatment:

Behavioral: Automated Text Messaging (ATM)

Behavioral: Standard Helpline (SH)

SH+CST+ATM

Experimental group

Description:

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

Treatment:

Behavioral: Automated Text Messaging (ATM)

Behavioral: Coping Skills Training (CST)

Behavioral: Standard Helpline (SH)

SH+MI

Experimental group

Description:

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

Treatment:

Behavioral: Motivational Interviewing (MI)

Behavioral: Standard Helpline (SH)

SH+MI+CST

Experimental group

Description:

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

Treatment:

Behavioral: Coping Skills Training (CST)

Behavioral: Motivational Interviewing (MI)

Behavioral: Standard Helpline (SH)

SH+MI+ATM

Experimental group

Description:

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

Treatment:

Behavioral: Automated Text Messaging (ATM)

Behavioral: Motivational Interviewing (MI)

Behavioral: Standard Helpline (SH)

SH+MI+CST+ATM

Experimental group

Description:

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

Treatment:

Behavioral: Automated Text Messaging (ATM)

Behavioral: Coping Skills Training (CST)

Behavioral: Motivational Interviewing (MI)

Behavioral: Standard Helpline (SH)