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临床试验/NCT04625465
NCT04625465已完成不适用

Proximal Effects of Alcohol on Same-Sex Intimate Partner Violence

Georgia State University1 个研究点 分布在 1 个国家目标入组 474 人开始时间: 2020年11月12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
入组人数
474
试验地点
1
主要终点
IPV Perpetration (Burst 4)

研究概览

简要总结

We will recruit sexual and gender minority couples to complete 56 days of daily surveys in order to evaluate (1) the impact of COVID-19 stress and sexual and gender minority stress on heavy episodic drinking and intimate partner violence (IPV) perpetration, and (2) a brief, mobile-phone delivered text messaging intervention to mitigate the effects of these stressors. This project has high potential to inform how pandemic stress contributes to etiological models of alcohol-related IPV perpetration in sexual and gender minority couples and inform a culturally-sensitive, low burden, and easy to disseminate intervention to mitigate these effects critical during a pandemic when access to care is limited.

研究设计

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

入排标准

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

入选标准

  • •(applies to both partners):
  • •Both partners must identify as cisgender and sexual minority or at least one partner must identify as a gender minority (i.e., one's gender identity is non-congruent with their sex assigned at birth)
  • •21 years or older
  • •In an intimate relationship lasting at least one month in which there are at least 2 days of face-to-face contact each week
  • •Consumption of 4 (assigned female at birth) or 5 (assigned male at birth) alcoholic drinks on at least three days in the past year

排除标准

  • •Seeking treatment or being in recovery for an alcohol or substance use disorder.
  • •Endorsement of severe physical IPV (e.g., use of a weapon) in the past year.
  • •Women who self-report that they are trying to get pregnant, that they are currently pregnant, or that they are currently breastfeeding .

研究组 & 干预措施

No Intervention, Attention-Control Texts (AB)

Active Comparator

Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.

干预措施: Attention Control Text Messaging (Behavioral)

No Intervention, No Intervention (AA)

No Intervention

Participants do not receive text messages during Interval 2 or Interval 3.

No Intervention, CBT Texts (AC)

Experimental

Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.

干预措施: CBT Text Messaging (Behavioral)

Attention-Control Texts, No Intervention (BA)

Active Comparator

Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.

干预措施: Attention Control Text Messaging (Behavioral)

Attention-Control Texts, Attention-Control Texts (BB)

Active Comparator

Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.

干预措施: Attention Control Text Messaging (Behavioral)

Attention-Control Texts, CBT Texts (BC)

Experimental

Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.

干预措施: CBT Text Messaging (Behavioral)

Attention-Control Texts, CBT Texts (BC)

Experimental

Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.

干预措施: Attention Control Text Messaging (Behavioral)

CBT Texts, No Intervention (CA)

Experimental

Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.

干预措施: CBT Text Messaging (Behavioral)

CBT Texts, Attention-Control Texts (CB)

Experimental

Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.

干预措施: CBT Text Messaging (Behavioral)

CBT Texts, Attention-Control Texts (CB)

Experimental

Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.

干预措施: Attention Control Text Messaging (Behavioral)

结局指标

主要结局

IPV Perpetration (Burst 4)

时间窗: Burst 4, Daily for 14 days

Proportion of reporting days on which IPV perpetration occurred

Alcohol Use --> IPV Perpetration (Pre-Intervention)

时间窗: Bursts 1 and 2 (daily for 14 x 2 days)

Odds ratio (OR) of IPV perpetration corresponding to alcohol use (versus non-use). Estimated using a multilevel logistic regression of daily IPV perpetration on alcohol use (Level 1) nested within participant (Level 2).

Alcohol Use --> IPV Perpetration (Post-Intervention)

时间窗: Bursts 3 and 4 (daily for 14 x 2 days)

Odds ratio (OR) of IPV perpetration corresponding to alcohol use (versus non-use). Estimated using a multilevel logistic regression of daily IPV perpetration on alcohol use (Level 1) nested within participant (Level 2).

Alcohol Use (Burst 1)

时间窗: Burst 1, Daily for 14 days

Proportion of reporting days on which alcohol was consumed

Alcohol Use (Burst 2)

时间窗: Burst 2, Daily for 14 days

Proportion of reporting days on which alcohol was consumed

Alcohol Use (Burst 3)

时间窗: Burst 3, Daily for 14 days

Proportion of reporting days on which alcohol was consumed

Alcohol Use (Burst 4)

时间窗: Burst 4, Daily for 14 days

Proportion of reporting days on which alcohol was consumed

Intimate Partner Violence (IPV) Perpetration (Burst 1)

时间窗: Burst 1, Daily for 14 days

Proportion of reporting days on which IPV perpetration occurred

IPV Perpetration (Burst 2)

时间窗: Burst 2, Daily for 14 days

Proportion of reporting days on which IPV perpetration occurred

IPV Perpetration (Burst 3)

时间窗: Burst 3, Daily for 14 days

Proportion of reporting days on which IPV perpetration occurred

Alcohol Use (Burst 1)

时间窗: Burst 1, Daily for 14 days

Proportion of reporting days on which alcohol was consumed

Alcohol Use (Burst 2)

时间窗: Burst 2, Daily for 14 days

Proportion of reporting days on which alcohol was consumed

Alcohol Use (Burst 3)

时间窗: Burst 3, Daily for 14 days

Proportion of reporting days on which alcohol was consumed

Alcohol Use (Burst 4)

时间窗: Burst 4, Daily for 14 days

Proportion of reporting days on which alcohol was consumed

Intimate Partner Violence (IPV) Perpetration (Burst 1)

时间窗: Burst 1, Daily for 14 days

Proportion of reporting days on which IPV perpetration occurred

IPV Perpetration (Burst 2)

时间窗: Burst 2, Daily for 14 days

Proportion of reporting days on which IPV perpetration occurred

IPV Perpetration (Burst 3)

时间窗: Burst 3, Daily for 14 days

Proportion of reporting days on which IPV perpetration occurred

IPV Perpetration (Burst 4)

时间窗: Burst 4, Daily for 14 days

Proportion of reporting days on which IPV perpetration occurred

Alcohol Use --> IPV Perpetration (Pre-Intervention)

时间窗: Bursts 1 and 2 (daily for 14 x 2 days)

Odds ratio (OR) of IPV perpetration corresponding to alcohol use (versus non-use). Estimated using a multilevel logistic regression of daily IPV perpetration on alcohol use (Level 1) nested within participant (Level 2).

Alcohol Use --> IPV Perpetration (Post-Intervention)

时间窗: Bursts 3 and 4 (daily for 14 x 2 days)

Odds ratio (OR) of IPV perpetration corresponding to alcohol use (versus non-use). Estimated using a multilevel logistic regression of daily IPV perpetration on alcohol use (Level 1) nested within participant (Level 2).

次要结局

  • Sexual Minority Stress (Burst 2)(Burst 2, Daily for 14 days)
  • Gender Minority Stress (Burst 2)(Burst 2, Daily for 14 days)
  • Gender Minority Stress (Burst 3)(Burst 3, Daily for 14 days)
  • Gender Minority Stress (Burst 4)(Burst 4, Daily for 14 days)
  • COVID Stress (Burst 1)(Burst 1, Daily for 14 days)
  • COVID Stress (Burst 2)(Burst 2, Daily for 14 days)
  • COVID Stress (Burst 3)(Burst 3, Daily for 14 days)
  • COVID Stress (Burst 4)(Burst 4, Daily for 14 days)
  • Sexual Minority Stress (Burst 1)(Burst 1, Daily for 14 days)
  • Sexual Minority Stress (Burst 2)(Burst 2, Daily for 14 days)
  • Sexual Minority Stress (Burst 3)(Burst 3, Daily for 14 days)
  • Sexual Minority Stress (Burst 4)(Burst 4, Daily for 14 days)
  • Gender Minority Stress (Burst 1)(Burst 1, Daily for 14 days)
  • Sexual Minority Stress (Burst 1)(Burst 1, Daily for 14 days)
  • Sexual Minority Stress (Burst 3)(Burst 3, Daily for 14 days)
  • Sexual Minority Stress (Burst 4)(Burst 4, Daily for 14 days)
  • Gender Minority Stress (Burst 1)(Burst 1, Daily for 14 days)
  • Gender Minority Stress (Burst 2)(Burst 2, Daily for 14 days)
  • Gender Minority Stress (Burst 3)(Burst 3, Daily for 14 days)
  • Gender Minority Stress (Burst 4)(Burst 4, Daily for 14 days)
  • COVID Stress (Burst 1)(Burst 1, Daily for 14 days)
  • COVID Stress (Burst 2)(Burst 2, Daily for 14 days)
  • COVID Stress (Burst 3)(Burst 3, Daily for 14 days)
  • COVID Stress (Burst 4)(Burst 4, Daily for 14 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dominic Parrott

Principal Investigator

Georgia State University

研究点 (1)

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