Helpline Pilot Factorial Trial
Helpline Delivery of Brief Interventions for Postpartum Heavy Episodic Drinking
1 other identifier
interventional
120
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2025
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
December 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
January 15, 2025
January 1, 2025
1.7 years
August 21, 2024
January 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Motivation to avoid alcohol
3-month follow-up; 6-month follow-up
Drinking self-efficacy
3-month follow-up; 6-month follow-up
Maternal self-efficacy
3-month follow-up; 6-month follow-up
Self-regulation
3-month follow-up; 6-month follow-up
Study Arms (8)
SH Only
ACTIVE COMPARATORParticipants receive standard helpline component only
SH+CST
EXPERIMENTALParticipants receive the standard helpline component and the cognitive coping skills component.
SH+ATM
EXPERIMENTALParticipants receive the standard helpline component and the automated messaging component.
SH+CST+ATM
EXPERIMENTALParticipants receive the standard helpline component, the cognitive coping skills component, and the automated messaging component.
SH+MI
EXPERIMENTALParticipants receive the standard helpline component and the motivational interviewing component.
SH+MI+CST
EXPERIMENTALParticipants receive the standard helpline component, the motivational interviewing component, and the cognitive coping skills component.
SH+MI+ATM
EXPERIMENTALParticipants receive the standard helpline component, the motivational interviewing component, and the automated messaging component.
SH+MI+CST+ATM
EXPERIMENTALParticipants receive the standard helpline component, the motivational interviewing component, the coping skills component, and the automated messaging component.
Interventions
One digital helpline session that includes assessment, psychoeducation, and links to resources. Participants are also offered ongoing asynchronous digital support from the helpline.
One digital helpline session that includes a structured motivational interviewing brief intervention.
One digital helpline session that includes a structured cognitive coping skills brief intervention.
Automated text messages are sent daily for 4 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice President
Study Record Dates
First Submitted
August 21, 2024
First Posted
September 19, 2024
Study Start
December 1, 2025
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2027
Last Updated
January 15, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- 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.
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.