跳至主要内容
临床试验/NCT06593652
NCT06593652招募中不适用

Evaluating Caregiver Involvement in Primary Care-Based Brief Interventions for Adolescent Alcohol Use Problems

Indiana University2 个研究点 分布在 1 个国家目标入组 615 人开始时间: 2025年8月19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
615
试验地点
2
主要终点
Timeline Follow-Back

研究概览

简要总结

Intervention for mild severity alcohol use among U.S. teens is crucial, as alcohol is the most commonly used substance in this age group, yet few receive the necessary interventions. Primary care, where over 90% of youth regularly visit, is an ideal setting for identifying and addressing mild alcohol use disorder (AUD) through brief interventions like motivational interviewing (MI) and cognitive-behavioral therapy (CBT). However, for teens with mild AUD, a single brief session may not be sufficient, raising questions about the role of caregiver involvement. This study seeks to determine the most effective level of caregiver involvement-no involvement, a single live session, or an online self-paced program-in reducing alcohol use among adolescents with mild AUD in primary care settings. The study also explores the impact of these interventions on other outcomes such as substance use and psychosocial functioning, as well as the factors influencing treatment response. The results will guide the selection and implementation of effective, scalable interventions in primary care to address youth alcohol use disorders.

详细描述

Detailed Description

Intervention for mild severity alcohol use is needed in primary care. Alcohol is the most commonly used substance among U.S. teens (lifetime use: 62% of 12th graders) and contributes to myriad harms, yet few youth who may benefit from intervention ever receive it. Primary care is an ideal setting for identifying and delivering brief interventions to youth with mild severity alcohol problems since over 90% of youth attend primary care visits routinely and substance use screening is standard practice. For youth with infrequent, low-risk use, brief (15-30 minute) motivational conversations may be sufficient to reduce risk. In contrast, youth with moderate to severe alcohol problems typically require more intensive interventions delivered by behavioral health specialists (e.g., intensive outpatient, residential treatment). A critical decision faced in primary care settings is what to do for youth who fall between these ends of the spectrum-namely, youth who show early signs of problematic use, meeting criteria for mild severity alcohol use disorder (AUD) (i.e., 2-3 symptoms; estimated to be approximately 3% of youth aged 12-17). Strong evidence supports individual-level brief interventions that incorporate motivational interviewing (MI) and basic cognitive-behavioral therapy (CBT) skills to help youth reduce substance use frequency, volume, and related impairment among youth with mild AUD.

Caregiver involvement in brief interventions for mild severity AUD may improve outcomes. Systematic reviews support interventions that address family-level factors (e.g., parents' attitudes, parenting behavior). When and how to involve parents or other primary caregivers in interventions for youth with mild severity AUD remains unclear. For instance, in a large school-based trial, brief MI+CBT without a caregiver session was equivalent to brief MI+CBT with a caregiver session on alcohol outcomes and drug consequences, whereas the MI+CBT with a caregiver session modestly outperformed the adolescent-only condition on cannabis-related outcomes.

Directly intervening with caregivers can be difficult and impractical. Despite the potential benefits of caregiver involvement, many caregivers see their child's behavior and choices as the main concern and therefore may be less inclined to participate in services focused exclusively on parenting practices. Caregivers may also have to miss work for parenting-dedicated sessions, which can disproportionately impact economically disadvantaged families. Asynchronous online programming may address some of these barriers-and preliminary findings support acceptability and efficacy of this approach-but such programs remain understudied relative to more traditional program structures. Identifying the relative effectiveness of online versus in-person caregiver components compared to youth-only interventions is critical to support decisions and eventual cost-benefit analyses about which programs to offer to different patients.

The primary research question this study aims to address is, "What type and level of caregiver involvement in a brief youth-focused intervention (i.e., Teen Intervene) results in the greatest reductions in alcohol use among adolescents with mild alcohol use disorder when delivered in a primary care context: no caregiver involvement, a single dedicated parent session, or a self-paced online parenting program?" Secondary research questions are "What is the relative impact of the three intervention models on other substance, academic, and behavioral health outcomes?" and "Do youth (i.e., personality, alcohol/substance risk perceptions, etc.) and family factors (i.e., parental monitoring) moderate treatment response?" Understanding implementation factors associated with each intervention is also of interest, as engaging caregivers in youth SUD services can be challenging. Thus, the outcomes of the current project will help inform the selection and delivery of interventions that are both effective and reasonable to implement in primary care contexts, where most youth receive healthcare services. When delivered at scale, such interventions could help address the alcohol and other substance use disorders affecting the U.S. today.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The data analysts will be masked to intervention condition.

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •12-17 years old;
  • •Mild to moderate severity for alcohol use (based on standardized surveys from their primary care provider or clinical indication) or other substance use
  • •English language fluency

排除标准

  • 未提供

研究组 & 干预措施

Teen Intervene - Adolescent Only

Active Comparator

Only the youth will participate in the brief intervention, Teen Intervene. The youth will participate in manual-standardized Teen Intervene sessions.

干预措施: Teen Intervene - Adolescent Only (Behavioral)

Teen Intervene - Caregiver Involvement

Experimental

The youth will participate in two Teen Intervene sessions. Additionally, the caregiver(s) will participate in a single, caregiver-only Teen Intervene session.

干预措施: Teen Intervene with Caregiver Session (Behavioral)

Teen Intervene - Online Caregiver Support Tool

Experimental

Only the youth will participate in the brief intervention, Teen Intervene. The youth will participate in two Teen Intervene sessions. Caregiver(s) will be provided with an online tool (Family Checkup Online) that addresses parenting strategies to support their youth.

干预措施: Family Check Up (Behavioral)

结局指标

主要结局

Timeline Follow-Back

时间窗: *0-at time of intervention, *3 months after time of intervention; *6 months after time of intervention; *12 months after time of intervention

30 items that assess daily alcohol usage over the past month will be administered to all participants. Participants will be queried about number of standard drinks consumed each day.

次要结局

  • Timeline Follow-Back(*0-at time of intervention, *3 months after time of intervention; *6 months after time of intervention; *12 months after time of intervention)
  • DAST-A(*0-at time of intervention, *3 months after time of intervention; *6 months after time of intervention; *12 months after time of intervention)
  • SUD Services Engagement(*0-at time of intervention, *3 months after time of intervention; *6 months after time of intervention; *12 months after time of intervention)
  • PROMIS Surveys(*0-at time of intervention, *3 months after time of intervention; *6 months after time of intervention; *12 months after time of intervention)

研究者

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

Zachary W. Adams

Associate Professor

Indiana University

研究点 (2)

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