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NCT Number: NCT06591026

Helpline Pilot Factorial Trial

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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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Helpline (SH)

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)

Behavioral

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

Coping Skills Training (CST)

Behavioral

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

Automated Text Messaging (ATM)

Behavioral

Automated text messages are sent daily for 4 weeks.

Primary outcomes

  1. Heavy episodic drinking

    Time frame: 3-month follow-up; 6-month follow-up

    Number of episodes of heavy episodic drinking, measured by the Timeline Follow Back.

Secondary outcomes

  1. Motivation to avoid alcohol

    Time frame: 3-month follow-up; 6-month follow-up

    Motivation to avoid alcohol use until the baby is one year old, assessed via the Maternal Motivation Scale. Likert scale 1-10.

  2. Drinking self-efficacy

    Time frame: 3-month follow-up; 6-month follow-up

    Total score on the Drinking Refusal Self-Efficacy Questionnaire.

  3. Maternal self-efficacy

    Time frame: 3-month follow-up; 6-month follow-up

    Total score on the Karitane Parenting Confidence Scale.

  4. Self-regulation

    Time frame: 3-month follow-up; 6-month follow-up

    Total score on the Coping Self-Efficacy Scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Dauber, PhD

CONTACT

[email protected]

212-841-5270

Sponsors and collaborators

Lead sponsor

The National Center on Addiction and Substance Abuse at Columbia University

Other

Registry information

Official study title

Helpline Delivery of Brief Interventions for Postpartum Heavy Episodic Drinking

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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