Helpline Pilot Factorial Trial

Helpline Delivery of Brief Interventions for Postpartum Heavy Episodic Drinking

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heavy Drinking
• Intervention / Treatment: Behavioral: Standard Helpline (SH); Behavioral: Coping Skills Training (CST); Behavioral: Automated Text Messaging (ATM); Behavioral: Motivational Interviewing (MI)

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Sarah Dauber, PhD; Phone Number: 212-841-5270; Email: sdauber@toendaddiction.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SH Only; Participants receive standard helpline component only	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.
Experimental: SH+CST; Participants receive the standard helpline component and the cognitive coping skills component.	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: Coping Skills Training (CST); One digital helpline session that includes a structured cognitive coping skills brief intervention.
Experimental: SH+ATM; Participants receive the standard helpline component and the automated messaging component.	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: Automated Text Messaging (ATM); Automated text messages are sent daily for 4 weeks.
Experimental: SH+CST+ATM; Participants receive the standard helpline component, the cognitive coping skills component, and the automated messaging component.	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: 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.
Experimental: SH+MI; Participants receive the standard helpline component and the motivational interviewing component.	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.
Experimental: SH+MI+CST; Participants receive the standard helpline component, the motivational interviewing component, and the cognitive coping skills component.	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: Coping Skills Training (CST); One digital helpline session that includes a structured cognitive coping skills brief intervention.; Behavioral: Motivational Interviewing (MI); One digital helpline session that includes a structured motivational interviewing brief intervention.
Experimental: SH+MI+ATM; Participants receive the standard helpline component, the motivational interviewing component, and the automated messaging component.	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: Automated Text Messaging (ATM); Automated text messages are sent daily for 4 weeks.; Behavioral: Motivational Interviewing (MI); One digital helpline session that includes a structured motivational interviewing brief intervention.
Experimental: SH+MI+CST+ATM; Participants receive the standard helpline component, the motivational interviewing component, the coping skills component, and the automated messaging component.	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: 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.; Behavioral: Motivational Interviewing (MI); One digital helpline session that includes a structured motivational interviewing brief intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heavy episodic drinking	Number of episodes of heavy episodic drinking, measured by the Timeline Follow Back.	3-month follow-up; 6-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motivation to avoid alcohol	Motivation to avoid alcohol use until the baby is one year old, assessed via the Maternal Motivation Scale. Likert scale 1-10.	3-month follow-up; 6-month follow-up
Drinking self-efficacy	Total score on the Drinking Refusal Self-Efficacy Questionnaire.	3-month follow-up; 6-month follow-up
Maternal self-efficacy	Total score on the Karitane Parenting Confidence Scale.	3-month follow-up; 6-month follow-up
Self-regulation	Total score on the Coping Self-Efficacy Scale.	3-month follow-up; 6-month follow-up

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: August 21, 2024
• First Submitted That Met QC Criteria: September 8, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Helpline R34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data from the factorial trial will be shared via the NIAAA Data Archive, in accordance with NIAAA's requirements for data sharing. No identifying information on participants will be shared.
• IPD Sharing Time Frame: In accordance with NIAAA recommendations, data will be deposited every 6 months until data collection is complete. Data will be available for as long as the NIAAA Data Archive allows.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No