Improving Medication Adherence in ADHD Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Medication Adherence
研究概览
简要总结
Investigates whether a family-based intervention for adolescents with Attention Deficit Hyperactivity Disorder (ADHD) will improve adherence to prescribed medication regimen in adolescents with history of medication nonadherence.
详细描述
We will evaluate a dual component family-based intervention for adolescents with ADHD to improve medication adherence (Supporting Teen Adherence and Responsibility; STAR). STAR pairs Motivational Interviewing with parent-teen behavioral contracting. In the proposed study, adolescents with ADHD and a history of chronic nonadherence to their ADHD medication will be randomly assigned to medication alone (medication as usual: MAU) or MAU+STAR. They will be treated for 6 months with a 12 month maintenance period and 12 month followup. All interventions will occur at the offices of participants primary care physicians.
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
- None
入排标准
- 年龄范围
- 12 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ADHD; currently prescribed an FDA-approved medication for ADHD, history of medication nonadherence (taking less than 60% of prescribed doses); full scale Intelligence Quotient >80, no current language delay and/or had no language delays before age 3.
排除标准
- •active medical conditions that could be worsened by stimulants (seizures, arrhythmias, hypertension) unless patient has clearance from primary specialist taking care of existing condition, pregnancy, Bipolar Disorder, schizophrenia, and/or other psychotic disorders, and diagnosis of current substance abuse or dependence (except nicotine), current psychotropic medication for conditions other than ADHD.
研究组 & 干预措施
Medication as usual
Medication as typically prescribed by physician.
干预措施: Medication as usual (Other)
Medication as usual + STAR
Medication as typically prescribed with the addition of the psychosocial intervention to improve medication adherence
干预措施: Medication as usual (Other)
Medication as usual + STAR
Medication as typically prescribed with the addition of the psychosocial intervention to improve medication adherence
干预措施: STAR (Other)
结局指标
主要结局
Medication Adherence
时间窗: Posttreatment (6 months)
Proportion of prescribed doses taken as measured by electronic monitoring devices.
次要结局
- Disruptive Behavior Disorder Rating Scale - Parent Report: Inattention(Posttreatment (6 months))
- Disruptive Behavior Disorder Rating Scale - Parent Report: Hyperactive-Impulsive(Posttreatment (6 months))
- Disruptive Behavior Disorder Rating Scale - Parent Report: Oppositional Defiant Disorder (ODD) Symptoms(Posttreatment (6 months))
- Disruptive Behavior Disorder Rating Scale - Parent Report: Conduct Disorder Symptoms(Posttreatment (6 months))
- Disruptive Behavior Disorder Rating Scale - Adolescent Report(Posttreatment (6 months))
- Disruptive Behavior Disorder Rating Scale - Adolescent Report: Hyperactive-Impulsive Symptoms(Posttreatment (6 months))
- Disruptive Behavior Disorder Rating Scale - Adolescent Report: Oppositional Defiant Disorder Symptoms(Posttreatment (6 months))
- Disruptive Behavior Disorder Rating Scale - Adolescent Report: Conduct Disorder Symptoms(Posttreatment (6 months))
- Impairment Rating Scale - Parent Report(Posttreatment (6 months))
- Impairment Rating Scale - Adolescent Report(Posttreatment (6 months))
- Maintenance of Medication Adherence(18 months)
- Followup Medication Adherence(30 months)