Benefits of In-prison OROS-methylphenidate vs. Placebo Treatment in Detained People With Attention-deficit/Hyperactivity Disorder: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Severity of ADHD core symptoms
研究概览
简要总结
Attention deficit hyperactivity disorder (ADHD) is characterized by difficulties paying attention, poor impulse control, and hyperactive behaviors. It is associated with several health and social detrimental outcomes and leads to increased risks of criminality and recidivism. However, to date, ADHD treatment has been neglected in prison. This project will test the efficacy of ADHD treatment using a randomized controlled trial.
详细描述
This project aims to compare the efficacy of a three-month in-prison OROS-methylphenidate vs. placebo treatment on the severity of ADHD core symptoms. Secondary outcomes address additional important in-prison and outpatient (in-prison or post-prison) aspects: 1) reduction in acute events in prison (e.g., disciplinary sanctions, violence, misuse of ADHD treatment), 2) evaluation of the risk of recidivism upon release, 3) three-month side effects of treatment, 4) in- and post-prison adherence to medication, 5) in- and post-prison study retention, 6) in- and post-prison costs-benefits of treatment, and 8) one-year rule-breaking behaviour. The outpatient part of the project will highlight long-lasting benefits of a treatment provided during three months while people are detained.
These research questions will be answered using a randomized controlled trial. After randomization, the participants will undertake three months of treatment with OROS-MPH or placebo (1:1 ratio) while they are incarcerated. After three months, all participants will be offered the possibility to have the treatment, but they will remain blinded regarding their initial study group. All of them will benefit of a cognitive-behavioral psycho-education program during detention and a cognitive-behavioral therapy after release.
The RCT will provide empirical-based evidence of the benefits of in-prison ADHD treatment using different perspectives: Clinical, behavioral, rule-breaking-related, and economical. The investigators expect that early detection and treatment of ADHD in prison will be an important public health opportunity and a cost-effective approach, likely to decrease the vulnerability of people living in detention and to promote pathways out criminal involvement.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants will be blinded to the 3-month (12 weeks with a one-week window) in-prison treatment.
The research team and statistician will be blinded to the participants' group. The psychiatrist will be unblinded when participants are released. At that time of the study, all participants will be offered to have the treatment (OROS-MPH) without being unblinded regarding their initial group.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 65
- •good command of French
- •stay in prison approx. 4 months at eligibility visit
- •endorsing clinical diagnostic criteria for DSM-5 ADHD
- •providing written informed consent
排除标准
- •presence of an acute uncontrolled comorbid psychiatric disorder
- •medical contraindication to stimulant prescription
- •potential adverse interaction with another medication
- •already receive ADHD treatment
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Pharmaceutical intervention (OROS-MPH)
Participants will receive OROS-MPH (Concerta® available in Switzerland as first-line treatment for ADHD). Dosages will be defined according to the Swiss Compendium. The psychiatrist (blinded during detention) will start with the smallest dosage (18 mg, Concerta®). The treatment will be monitored weekly the first month, and then monthly. The pharmacy of the Geneva University Hospitals will be in charge of over-encapsulating medications.
干预措施: Concerta (Drug)
结局指标
主要结局
Severity of ADHD core symptoms
时间窗: 3 months
Conners Adult ADHD Rating Scale, range 0-78, higher score indicates worse outcome
次要结局
- Number of acute events(3 months)
- Score of risk of recidivism(3 months)
- Percentage of adherence to medication(3 months and 12 months in outpatient care)
- Percentage of retention to study(12 months in outpatient care)
- Costs(3 months (medical and prison-related costs) and 12 months in outpatient care (prison-related costs))
- Number of rule-breaking events(12 months in outpatient care)
研究者
Stéphanie Baggio
Prof.
University Hospital, Geneva