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临床试验/NCT03589508
NCT03589508已完成不适用

Testing A Couple-based Program for Alcohol Risk Reduction in the National Guard

University of Massachusetts, Worcester2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2016年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
2
主要终点
Attitude Items

研究概览

简要总结

The purpose of this project is to develop and test indicated prevention intervention to harness support and health promoting endeavors to address use of alcohol to cope with reintegration challenges in Massachusetts National Guard (MANG) service members.

详细描述

Specific Aim 1: To modify the existing, efficacious Alcohol Behavioral Couple Therapy (ABCT) manual into a 6-session prevention protocol, called Alcohol Behavioral Couple Prevention (ABCP) that will be developed for delivery via in-person and telehealth platforms. The goal of the new ABCP is for individuals or family dyads to learn to work together to minimize hazardous drinking in order to effectively address other problems often present among returning service members.

Specific Aim 2: To field test feasibility and preliminary efficacy of a prevention protocol using a successive cohort design. First, an in-person protocol will be tested with 4 National Guard (NG) members and then adapt and test the protocol for 4 NG members via an analog telehealth design. Again, the manual and accompanied materials will be revised.

Specific Aim 3: To conduct a small Randomized Controlled Trial (RCT) to compare 2 conditions with 22 NG Members in each: (1) In person (ABCP_P; 11 individual, 11 dyad), and (2) Telehealth (ABCP_T; 11 individual, 11 dyad).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • for NG member:
  • Age 18 and older and a member of the MANG.
  • Have a SO or trusted friend who is 18 or older
  • Service member endorsed one item on the 10-item Alcohol Use Disorders Identification Test within their lifetime

排除标准

  • unable to give consent
  • Prisoners
  • Principal Investigators determined the participant requires a higher level of care (based on unstabilized psychiatric disorder, and/or high drinking or drug use severity, and/or inability to attend to adl's and/or agitated behavior
  • Service Member is unable to read or comprehend English at the 7th grade education level

研究组 & 干预措施

In-Person Sessions: ABCP_P

Experimental

In-person therapy sessions: 6 Weekly Prevention Session conducted in person (half of participants will attend alone, half of participants will attend with a significant other)

干预措施: In-person sessions: ABCP_P (Behavioral)

Video conference sessions: ABCP_T

Experimental

Video conference therapy sessions: 6 Weekly Prevention Session conducted using videoconference (half of participants will attend alone, half of participants will attend with a significant other)

干预措施: Video conference sessions: ABCP_T (Behavioral)

结局指标

主要结局

Attitude Items

时间窗: Baseline and through study completion, about 8 weeks

6 item self-report questionnaire assessing attitudes toward drinking under different circumstances. Item scores were summed to calculate total scores, with scores ranging from 6 to 24. Higher scores indicate greater attitudes about acceptability of drinking across situations.

Percent Drinking Days

时间窗: Change from baseline at 2 months post session 1

Derived from Timeline Followback (TLFB)

Percent Heavy Drinking Days

时间窗: Change from baseline at 2 months post session 1

Derived from Timeline Followback (TLFB)

Mean Drinks Per Drinking Day

时间窗: Change from baseline at 2 months post session 1

Derived from Timeline Followback (TLFB)

次要结局

  • Coping Strategies Scale(Change from baseline at 2 months post Session 1)
  • Alcohol Expectancies Questionnaire 3(Change from baseline at 2 months post Session 1)
  • Treatment Services Review(Weekly for up to 8 weeks)
  • Couple Satisfaction Inventory 16(Baseline and through study completion, about 8 weeks)
  • Perceived Social Support - Family(Baseline and through study completion, about 8 weeks)
  • Outcomes Questionnaire (OQ) - 30(Baseline and through study completion, about 8 weeks)
  • Working Alliance Inventory Short Form(Baseline and through study completion, about 8 weeks)
  • Use of Prevention Skills(Baseline and through study completion, about 8 weeks)
  • Copello Coping Questionnaire(Baseline and through study completion, about 8 weeks)
  • World Health Organization Quality of Life (WHOQOL) Questionnaire - Bref(Change from baseline at 2 months post Session 1)

研究者

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Epstein

Professor

University of Massachusetts, Worcester

研究点 (2)

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