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临床试验/NCT06591026
NCT06591026尚未招募1 期

Helpline Delivery of Brief Interventions for Postpartum Heavy Episodic Drinking

The National Center on Addiction and Substance Abuse at Columbia University0 个研究点目标入组 120 人开始时间: 2025年12月1日最近更新:
适应症

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
120
主要终点
Heavy episodic drinking

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Heavy episodic drinking

时间窗: 3-month follow-up; 6-month follow-up

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

次要结局

  • 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)

研究者

发起方
The National Center on Addiction and Substance Abuse at Columbia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah Dauber

Vice President

The National Center on Addiction and Substance Abuse at Columbia University

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