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临床试验/NCT03592186
NCT03592186已完成不适用

Adolescents With Substance Use Disorders Transitioning From Residential Treatment to the Community: Improving Outcomes Via a Computer Assisted Parenting Program

Brown University4 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2017年4月1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
122
试验地点
4
主要终点
Change in Proportion of Days Used Outside of Controlled Environment

研究概览

简要总结

Adolescents with substance use disorders (ASUD) in residential treatment have the most serious substance use disorders and the highest rates of psychological, motivational, behavioral, legal, environmental, and vocational problems. ASUD in residential treatment are also at high risk of relapse, with follow-up studies suggesting that 60% of ASUD will relapse within 90 days of discharge. Parenting practices have been established as a key influence on adolescents' initiation and maintenance of substance use, as well as their substance use outcomes and likelihood of relapse. However, therapists who treat ASUD have reported a myriad of systemic barriers to engaging parents in treatment. Findings such as these deem ASUD in residential treatment a high priority population and argue for the value of easily accessible parenting interventions during this critical time. The proposed study evaluates a low cost, low intensity model for delivering parenting skills to parents preparing for their adolescent's discharge from residential substance use (SU) treatment. Specifically, this project involves adapting the delivery of a computerized parenting intervention (Parenting Wisely; PW) that has preliminary evidence of efficacy in improving parenting skills and reducing youth behavior problems. This study adapts the delivery of PW for a new population (parents of ASUD) and new setting (residential treatment), and obtains initial data on its feasibility, acceptability, and effectiveness. As a first step, an open trial with 10 parents was conducted to develop and pilot an adapted version of PW that included moderate engagement strategies: in-person coaching sessions, daily text messages containing reminders of parenting skills and links to video vignettes, and an online parent forum containing two networking boards (Ask an Expert and Connect with Parents). In the current phase, a pilot randomized trial with 60 parents will compare an adapted PW plus treatment as usual (TAU) condition (PW+) versus TAU only in a residential treatment center. Both treatment conditions will be delivered by Bachelor's or Master's-level community clinicians. This small trial will provide some initial evidence regarding the utility of a low-cost, low-intensity intervention and whether a larger, fully powered trial is indicated in the future.

详细描述

This small pilot trial evaluates a low cost, low intensity model for delivering parenting skills to parents preparing for their adolescent's discharge from residential substance use (SU) treatment. Specifically, this project adapts a computerized parenting intervention (Parenting Wisely; PW) that has preliminary evidence of efficacy in improving parenting skills and reducing youth behavior problems for a new population (parents of adolescents with SU) and new setting (residential treatment).

Participants: A minimum of 60 parent-adolescent dyads will be recruited from residential treatment. To guide design decisions for a larger trial, we made the decision after trial registration to recruit from one short-term residential treatment program and one long-term residential treatment program. Parental inclusion criteria: (1) be parent or legal guardian of an adolescent, aged 12-17 years; (2) had adolescent admitted to residential treatment due to problems related to substance use; (3) will be the primary guardian living with the adolescent immediately post-discharge; (4) willing to receive a parenting intervention; (5) fluent in English or Spanish; and (6) willing to provide written consent. Adolescents qualify if their parents meet these criteria as well as: (1) are fluent in English or Spanish and (2) willing to provide written assent. The only exclusion criteria are conditions that might preclude the adolescent's or parent's participation in a 2-3 hour interview (e.g., mania, psychosis, and cognitive impairment).

Study enrollment and randomization: Parents of all newly admitted adolescents will be screened for substance use and those screening positive, will receive a Consent to Contact (CoC) form. Parents that sign a CoC form will be contacted by research staff and invited in for a consent session.

Parents will provide written informed consent and adolescents will provide written assent in separate private rooms at the residential center. Parents and adolescents may choose to conduct the informed consent process and all study procedures in English or Spanish.

Parents will be given the choice whether to return for the baseline assessment or complete it following informed consent. Randomization will occur within 24 hours after the baseline assessment. Parent-adolescent dyads will be randomized by a blind research staff member to either treatment as usual or PW+ using urn randomization balanced on sex, frequency of substance use, and race/ethnicity. The evaluator will give parents condition assignments in sealed envelopes. If the parent is assigned to PW+, the evaluator will schedule the first coaching session. Coaching sessions were offered via multiple modalities to increase engagement: in-person, phone, or video conference.

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)

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in Proportion of Days Used Outside of Controlled Environment

时间窗: Change from baseline to 24-week post-discharge

Global Appraisal of Individual Needs - Quick Version (GAIN-Q3) is a well-validated substance use screening tool used to assess adolescent substance use in a range of settings. Substance consumption information is collected using a calendar format with temporal cues (e.g., holidays) to assist in recall of days when alcohol and other drugs were used. Possible number of days range from 0 to 90. Values are adjusted to reflect the proportion of days used outside of controlled environment, with final values ranging from 0 to 1.0; a higher number indicates a higher proportion of days used.

次要结局

  • Change in Global Appraisal of Individual Needs - Quick Version (GAIN-Q3) Substance-Related Problems Scale(Change in substance-related problems from baseline to the 24-week post-discharge assessment)
  • Count of Adolescents Testing Negative on Urine Screens(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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