Substance Use Prevention for Youth With Parents in Recovery: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Participation metrics
研究概览
简要总结
Risk for substance use disorder (SUD) begins early in the life course. Although preventing and decreasing illicit and nonmedical drug use among youth is an urgent public health priority, there are currently few evidence-based prevention strategies feasible for delivery in the primary care setting. The investigators propose a three-year plan to collect critical pilot data to pilot test and optimize a dyadic intervention that aims to increase family resilience, strengthen coping skills, help families plan for the future, and prevent youth SUD.
The 'prototype' for the intervention approach is Family Talk, an evidence-based parent-youth dyadic intervention that can be delivered within the existing infrastructure of the patient-centered medical home. The investigators have made preliminary adaptations to the model in preparation for testing. To prepare for a subsequent efficacy study, a two-arm pilot randomized controlled trial of the intervention with 40 parent-youth dyads to optimize the intervention model will be conducted. The feasibility of the intervention will be evaluated. In addition, empiric estimates of study parameters to inform the planning of a fully powered randomized controlled trial and plausible intervention targets using semi-structured qualitative interviews will be obtained.
详细描述
Within the context of a pilot randomized controlled trial, the objectives are to: 1. Optimize the content and delivery of the intervention through an iterative series of quality improvement cycles informed by structured feedback from parents, youth, and intervention providers after each session; 2. Field test study logistics, including participant recruitment, willingness to consent to a randomized trial; loss to follow-up; the acceptability and feasibility of the study measures; and 3. Obtain empiric estimates of study parameters to inform future clinical trial design, including within-group standard deviation of continuous measures; correlations of repeated measures; and proportion of control group subjects who experience each outcome. The products at the end of the pilot study will be an optimized intervention model, developed with parent and youth input and ready for efficacy testing; and a set of putative intervention targets ready to be tested in the subsequent trial. The ultimate goal is to develop an effective approach to youth substance use prevention, delivered within the infrastructure of the patient-centered medical home. If successful, this trajectory of work has the potential to identify a novel, family-centered approach to substance use disorder prevention for a high-risk population of youth whose parents are in recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12-18 years without diagnosed SUD
- •Comfortable speaking English or Spanish
- •Inclusion Criteria for parent:
- •18 years or older
- •Receiving treatment for SUD
- •Receiving substance use care in the CODAC system
- •Comfortable speaking English or Spanish
排除标准
- •Presence of acute family crisis, such as recent death, incarceration, separation, divorce, or other stressor
- •Parent or youth with cognitive limitation or intellectual disability
研究组 & 干预措施
Intervention refinement arm
20 parent-youth [12-18 years old] dyads will be randomized to this arm and receive the Modified Family Talk intervention.
干预措施: Modified Family Talk (Other)
Parameter estimation arm
20 parent-youth dyads randomized to this control-like arm will receive current best practice care in the patient-centered medical home
干预措施: Control-like parameter estimation (Other)
结局指标
主要结局
Participation metrics
时间窗: 12 months
The number of families approached and screened for the project, number ineligible, number refusing participation, and number ultimately enrolled will be assessed
Reasons for not enrolling
时间窗: 12 months
An investigator created questionnaire will be obtain the reasons why eligible potential participants did not enroll in the study.
Study attrition rates
时间窗: 12 months
The percent of participants will be calculated by dividing the number of participants that complete the study by the total number of participants enrolled.
Person-time of sessions
时间窗: throughout the study up to 12 months
The total and average person time for sessions delivered by the intervention providers will be tracked.
Number of sessions
时间窗: throughout the study up to 12 months
The number of sessions delivered by the intervention providers will be tracked.
次要结局
- Depression(3 months, 6 months, 12 months)
- Family Functioning(3 months, 6 months, 12 months)
- Perceived Stress(3 months, 6 months, 12 months)
- Problem solving skills(3 months, 6 months, 12 months)
- Youth perceptions of peer, sibling, parental substance use(3 months, 6 months, 12 months)
- Social support(3 months, 6 months, 12 months)
- Youth substance use in preceding 90 days(90 days)
- Family Communication(3 months, 6 months, 12 months)
- Types of coping strategies(3 months, 6 months, 12 months)
- Youth substance use screening(12 months)
- Self-efficacy coping strategies(3 months, 6 months, 12 months)