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临床试验/NCT05743699
NCT05743699招募中不适用

Adaptation and Evaluation of Bright Horizons: An Evidence Based Intervention for Prevention of Binge Drinking and Drug Use

Johns Hopkins Bloomberg School of Public Health1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年7月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Change in Alcohol Use as assessed by Timeline Followback

研究概览

简要总结

This study will test if a program called 'Bright Horizons' is effective at reducing binge substance use among adolescents.

Bright Horizons is a culturally adapted intervention developed and tested through a partnership between The White Mountain Apache Tribe and Johns Hopkins University. Bright Horizons is a brief intervention that teaches emotion regulation, coping skills, and problem solving. The intervention also uses goal setting to reduce alcohol and other substance use and to connect to individuals with treatment.

详细描述

The goal of this study is to understand how Bright Horizons impacts adolescents who have a recent binge substance use event. Participants will receive a lesson on binge substance use and answer questions at three different time points: when participants enroll in the study; 4 weeks later; and 8 weeks after that visit. Evaluation questions will ask about participants' substance use, family and peer relationships, and other emotions and behaviors.

Control participants will receive the Bright Horizons intervention after enrollment of all intervention participants is complete.

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
10 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 10-24
  • Confirmed binge alcohol use event reported to the surveillance system within 90 days
  • Self identify as Native American
  • Reside on or near the Fort Apache Indian Reservation
  • Have parental or legal guardian consent/provide youth assent

排除标准

  • Unstable and severe medical, psychiatric or drug use problems that necessitates inpatient treatment
  • Acute suicidal or homicidal ideation requiring immediate intervention
  • Recent and severe stressful life events such as physical or sexual abuse, or violent crime victimization that requires specific and high intensity interventions or out of home placement
  • Doesn't speak English
  • Severally visually impaired

研究组 & 干预措施

Case management + Bright Horizons

Experimental

Participants enrolled into the Bright Horizons intervention group will receive one 2-4 hour long session with an Research Program Assistant.

干预措施: Bright Horizons (Behavioral)

Case management + Bright Horizons

Experimental

Participants enrolled into the Bright Horizons intervention group will receive one 2-4 hour long session with an Research Program Assistant.

干预措施: Case Management (Behavioral)

Case management

Placebo Comparator

Participants in the control group will receive standard case management via the White Mountain Apache suicide and self-harm surveillance system.

干预措施: Case Management (Behavioral)

结局指标

主要结局

Change in Alcohol Use as assessed by Timeline Followback

时间窗: Baseline, 4 weeks and 8 weeks post-intervention

Alcohol use over the past 30 days (Timeline Followback to assess number of drinking days and number of drinks per day)

次要结局

  • Other substance use as assessed by the Youth Risk Behavior Survey (YBBS)(Baseline, 4 weeks, 8 weeks)
  • Enculturation as assessed by the Tribal identification scale(Baseline, 4 weeks, 8 weeks)
  • Coping with Stressful Life Events as assessed by the Difficulties in emotion regulation scale(Baseline, 4 weeks, and 8 weeks)
  • Impulsivity as assessed by the UPPS Impulsive Behavior Scale(Baseline, 4 weeks, 8 weeks)
  • Family Functioning as assessed by the Problem-oriented screening instrument (POSIT) Family Functioning scale(Baseline, 4 weeks, 8 weeks)
  • Peer Relationships as assessed by the Peer Norms questionnaire(Baseline, 4 weeks, 8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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