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临床试验/NCT04604236
NCT04604236已完成不适用

Increasing Family Engagement and Treatment Initiation Through Family Assessment, Motivation,and Linkage Intervention (FAMLI)

Texas Christian University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年7月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
2
主要终点
Youth Initiation

研究概览

简要总结

The R34 study will integrate existing tools for use with JJ populations and examine the feasibility, acceptability, and preliminary efficacy of a caregiver-youth intervention aimed at increasing SU treatment initiation. The adaptive intervention incorporates three evidence-based components: 1) assessment of motivation and linkage-related barriers with personalized feedback, 2) Mapping-Enhanced Counseling (MEC) for improving readiness for change and interpersonal communication, and 3) Active Linkage (AL) for addressing logistical barriers to service initiation. Youth-caregiver dyads will be randomly assigned to receive an initial dose (2, 1-hr sessions) of either MEC or AL. After 30 days, participants will be classified as Responders (1 or more services initiated) or Non-responders (no service initiation). All participants will be randomized to one of two intervening interventions: an additional dose (2, 1-hr sessions) of the initial intervention (MEC or AL) or a different dose (2, 1-hr sessions of the other). The specific aims are to 1) integrate and adapt appropriate evidence-based intervention components as a dyadic intervention approach for JJ youth and caregivers; 2) test the feasibility, acceptability, and optimal configuration of the dyadic intervention components and the protocol used to evaluate effectiveness (including feasibility of recruitment, implementation, measurement); and 3) preliminarily explore a) whether an initial dose of MEC or AL is sufficient for promoting early initiation and engagement, b) whether an additional dose of MEC or AL or a change in dose is more effective, and c) which component sequence is most effective. Primary outcomes include youth (initiation of assessment or counseling; counseling attendance) and caregiver (attendance at assessment, first counseling, and/or family sessions) measures. Secondary outcomes include youth and caregiver attitudes (problem recognition, desire for help), normative beliefs (SU norms), perceived control (stressors and obstacles), and youth SU (self-report corroborated by UA results). The study addresses the sizeable gap in service receipt among JJ youth by addressing family engagement, and focuses on improving motivation to change, linkage to services, and treatment engagement.

研究设计

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

入排标准

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

入选标准

  • pre or post adjudicated or deferred prosecution
  • have an identified SU need within the past 12 months (confirmed by the TCU Drug Screen-5 during initial assessment)
  • speak English
  • no indication of active suicide risk
  • can identify one parent/guardian/responsible adult (caregiver) that is willing to participate who speaks Spanish or English

排除标准

  • 未提供

结局指标

主要结局

Youth Initiation

时间窗: Week 17

Youth attendance at 1 or more treatment appointment (assessment or counseling), obtained through self-report and corroborated using probation agency attendance records

Caregiver attendance with youth at 1 or more treatment appointment

时间窗: Week 17

Caregiver attendance with youth at 1 or more treatment appointment (assessment, counseling)

次要结局

  • Change in Youth Normative Beliefs about Substance Use as measured by the TCU THK Form(Weeks 1, 9, and 17)
  • Change in Caregiver Normative Beliefs about Substance Use as measured by the TCU THK Form(Weeks 1, 9, and 17)
  • Change in Youth Treatment Motivation as measured by the TCU MOT Form(Weeks 1, 9, and 17)
  • Change in Caregiver's Perception of Youth's Treatment Motivation as measured by the TCU MOT Form(Weeks 1, 9, and 17)
  • Change in Youth Perceived Control over Substance Use as measured by the TCU THK Form(Weeks 1, 9, and 17)
  • Change in Youth Perceived Control over Treatment Initiation as measured by the Barriers to Treatment Participation Scale (BTPS)(Weeks 1, 9, and 17)
  • Change in Caregiver Perceived Control over Youth's Substance Use as measured by the Caregiver Strain Questionnaire (CGSQ-SF7):(Weeks 1, 9, and 17)
  • Change in Youth Intentions to Use Substances as measured by the TCU THK Form(Weeks 1, 5, 9, and 17)
  • Change in Caregiver Intentions to schedule and attend youth's treatment sessions(Weeks 1, 5, 9, and 17)
  • Change in Caregiver Perceived Control over Youth's Treatment Initiation as measured by the Barriers to Treatment Participation Scale (BTPS)(Weeks 1, 9, and 17)
  • Change in Youth Intentions to Initiate Treatment(Weeks 1, 5, 9, and 17)
  • Change in Family relationships as measured by the TCU FFS Scale(Weeks 1, 9, and 17)
  • Change in Youth Substance Use as measured by the TCUDS and Opioid Supplement Forms(Weeks 1, 5, 9, and 17)
  • Change in Family responsiveness as measured by the Family Assessment Device (FAD)(Weeks 1, 9, and 17)

研究者

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

DanicaKnight

Principal Investigator

Texas Christian University

研究点 (2)

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