Benefits of ADHD Treatment in Detained People

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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 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 recidivism. The post-prison part of the project will highlight long-lasting benefits of a treatment provided 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. Upon release, 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, recidivism-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.

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

Conditions
-----------------
ADHD

Intervention / Treatment
-----------------
* Drug: Concerta
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 18 and 65 good command of French going to be released in approx. 4 months at eligibility visit endorsing clinical diagnostic criteria for DSM-5 ADHD providing written informed consent Exclusion Criteria: presence of an acute uncontrolled comorbid psychiatric disorder going in a closed centre after release from prison medical contraindication to stimulant prescription potential adverse interaction with another medication already receive ADHD treatment do not plan to stay in Switzerland for at least one year.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a phase 3 parallel randomized controlled trial (1:1 ratio) of OROS-MPH vs. a placebo on a clinical outcome. Pparticipants will undertake three months of treatment while they are incarcerated. Upon release, all participants will be offered treatment in electronic monitors (without being unblinded on the treatment they received during detention). They will be followed-up for twelve months after release (total study duration: 15 months).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmaceutical intervention (OROS-MPH)<br>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. | Drug: Concerta<br>* 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, hyperactivity, and for this project, behavioral problems. In general, the dose can be increased in 18 mg at weekly intervals. The treatment will be monitored weekly the first month, and then monthly, except for side effects which will be monitored daily in prison and every two weeks after release.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of ADHD core symptoms | Conners Adult ADHD Rating Scale, range 0-78, higher score indicates worse outcome | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of acute events | Refusal to see doctors, nurses or lawyers, hunger strikes, self-harm events requiring a visit to the medical unit, fights requiring a visit to the medical unit, and disciplinary sanctions | 3 months | 
| Score of risk of recidivism | Dynamic risk assessment tool will be used to evaluate the risk of recidivism, score 0-30, higher score indicates better outcome | 3 months | 
| Percentage of adherence to medication | Binary variable (yes=adherence to medication, no=absence of adherence to medication) | 3 months and 12 months after release | 
| Percentage of retention to study | Binary variable (yes=remain in the study, no=dropout from the study) | 12 months after release | 
| Costs | Medical costs (costs of medical services used by patients (outpatient, emergency, and inpatient resources) and prison-related costs (disciplinary sanctions, use of resources in the prison and in prison staff and recidivism-related costs, average cost for one day in prison), two quantitative variables in Swiss francs. | 3 months (medical and prison-related costs) and 12 months after release (prison-related costs) | 
| Number of recividism events | Data from the official Swiss criminal records (Federal Office of Statistics, Criminal Conviction Statistics), binary variable (yes=recidivism, no=no recidivism) | 12 months after release | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prison, Health care, Adherence to treatment, Recidivism