Feasibility and Acceptability of Home-based Continuing Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Young Adult Drug Use from Baseline to 16 week and 32 week follow-ups
研究概览
简要总结
The purpose of this project is to develop and test a Home-based Continuing Care intervention that will help parents support the recovery of their Young Adult (YA) child who is leaving residential substance abuse treatment. The two phase pilot study will 1) interview 50 parents and 50 YAs recruited from residential treatment programs and from parent groups to inform the development of the intervention and 2) conduct a two-arm pilot study that will recruit a maximum of 20 parents and their young adult children into one of two conditions (Home-based Continuing Care [HCC] intervention group or Services as Usual [SAU] comparison group) with the main goal of determining whether conducting such an intervention is acceptable and sustainable, and to collect preliminary efficacy data. We hypothesize that pilot testing will indicate that: (a) HCC is acceptable and potentially sustainable; (b) conducting a randomized clinical trial is feasible, and (c) the magnitude of outcomes from HCC will be clinically meaningful.
详细描述
Several models of continuing care (CC) have been studied for adolescents and Young Adults (YAs) including online relapse prevention, brief telephone counseling and Assertive Continuing Care (ACC). Five sessions of in-person therapy or brief telephone counseling both have reduced relapse in youth completing treatment relative to a no CC condition, consistent with a growing body of research with adults supporting the efficacy of telephone-based CC (TCC). ACC has been thoroughly evaluated for adolescents. Some applications also have incorporated contingency management (CM) for engaging in activities including needed services; but ACC has not applied CM to biologically-verified abstinence -- an efficacious approach in adult CC. A significant drawback of ACC is that it is quite intensive, requiring extended clinician training and home visits. This increases the costs of the intervention and the difficulty of dissemination and implementation; therefore we plan to develop a less clinician-intensive continuing care model for YAs.
The two phase pilot study will 1) interview 50 parents and 50 YAs recruited from residential substance abuse treatment programs and from parent groups to inform the development of the intervention and 2) conduct a two-arm pilot study that will recruit a maximum of 20 parents and their YA children into one of two conditions (Home-based Continuing Care [HCC] intervention group or Services as Usual [SAU] comparison group) with the main goal of determining whether conducting such an intervention is acceptable and sustainable, and to collect preliminary efficacy data. We hypothesize that pilot testing will indicate that: (a) HCC is acceptable and potentially sustainable; (b) conducting a randomized clinical trial is feasible, and (c) the magnitude of outcomes from HCC will be clinically meaningful.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent is 21 years of age or older
- •Young Adult (YA) is 18-25 years of age
- •YA's primary drug of abuse is prescription or other opiates
- •Parent must be the custodial parent or former guardian or other caretaker of the YA
- •YA is in residential treatment
- •Parent and YA plan to live in the same residence during the intervention (32 weeks)
- •Both Parent and YA provide written informed consent and pass the consent quiz testing knowledge of basic elements of informed consent and study requirements (including home urine testing).
排除标准
- •Parent currently has a substance use disorder (SUD) as determined via DSM-IV-TR criteria or a history of SUD and in recovery for less than 2 years
- •Parent or YA has been diagnosed as having, or behaves in, a manner consistent with having significant cognitive impairment (e.g., an unrelieved psychosis or other serious mental illness)
- •YA reports suicidal ideation with a plan, or engaged in suicidal behavior during residential treatment
- •YA has a recent history of severe violence toward the parent (e.g., involving weapons or hospitalization)
- •YA's residential program provides comprehensive continuing services
- •YA does not consent to participation within 2 weeks of discharge
结局指标
主要结局
Change in Young Adult Drug Use from Baseline to 16 week and 32 week follow-ups
时间窗: Baseline, Weekly, 16 week and 32 week follow-ups
Young Adult participants will complete a Timeline Follow Back (Baseline, 16 week and 32 week follow-ups) and provide a urine sample to be tested for drug and alcohol use (Baseline, Weekly, 16 week and 32 week follow-ups).
次要结局
- Parent and Young Adult Recruitment Rate by monthly recruitment rate(10 month recruitment period)
- Parent and Young Adult Recruitment Rate by percent approached(10 month recruitment period)
- Parent and Young Adult Treatment Acceptability(16 week and 32 week follow-ups)
- Parent and Young Adult Research Retention(16 week and 32 week follow-ups)
- Change in Parent and Young Adult Relationship Satisfaction from Baseline to 16 week and 32 week follow-ups(Baseline, 16 week and 32 week follow-ups)
- Parent and Young Adult Treatment Retention(32 weeks post baseline)
- Parent and Young Adult Engagement in HCC by urine sample collected(32 week intervention period)
- Parent and Young Adult Engagement in HCC by number of calls completed(32 week intervention period)