Benefits of ADHD Treatment in Detained People

Официальное название

Benefits of In-prison OROS-methylphenidate vs. Placebo Treatment in Detained People With Attention-deficit/Hyperactivity Disorder: A Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Concerta
  Dosages of Concerta® will be defined according to the Swiss Compendium (from 18 to 72 mg/d). The psychiatrist will start with the smallest dosage (18 mg) and will adapt it on a weekly basis or on need, depending on tolerance (side effects measured at each visit), clinical response (subjective improvement felt by the patient in terms of attention, impulsivity, and hyperactivity), and according to the observations made by the professionals or patient's entourage in term of attention, impulsivity,
• Препарат Placebo
  The placebo will be strictly identical (same packaging, size no. 2 and color according to dosage, with no label). Procedure for adjustment of dosage will be the same as in the Concerta arm.

Первичные конечные точки

• Severity of ADHD core symptoms [Срок оценки: 3 months]

Вторичные конечные точки (6)

• Number of acute events [Срок оценки: 3 months]
• Score of risk of recidivism [Срок оценки: 3 months]
• Percentage of adherence to medication [Срок оценки: 3 months and 12 months in outpatient care]
• Percentage of retention to study [Срок оценки: 12 months in outpatient care]
• Costs [Срок оценки: 3 months (medical and prison-related costs) and 12 months in outpatient care (prison-related costs)]
• Number of rule-breaking events [Срок оценки: 12 months in outpatient care]

Критерии участия

Критерии включения

• 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

Критерии исключения

• presence of an acute uncontrolled comorbid psychiatric disorder
• medical contraindication to stimulant prescription
• potential adverse interaction with another medication
• already receive ADHD treatment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• Geneva University Hospitals — Geneva

Публикации

• Baggio S, Billieux J, Dirkzwager A, Iglesias K, Moschetti K, Perroud N, Schneider M, Vernaz N, Wolff H, Heller P. Protocol of a monocentric, double-blind, randomized, superiority, controlled trial evaluating the effect of in-prison OROS-methylphenidate vs. placebo treatment in detained people with attention-deficit hyperactivity disorder (BATIR). Trials. 2024 Jan 4;25(1):23. doi: 10.1186/s13063-02 PMID 38178233

Идентификаторы

NCT: NCT05842330 · 32003B_212581

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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