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NCT Number: NCT05842330

Benefits of ADHD Treatment in Detained People

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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Behavior Criminal Behavior Health Behavior Mental Disorders Neurodevelopmental Disorders Recidivism Treatment Adherence and Compliance

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Geneva University Hospitals

Geneva, Canton of Geneva, 1211, Switzerland

Location status: Recruiting

Location contact

Patrick Heller, MD

CONTACT

[email protected]

+41223055218

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Concerta

Drug

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.

Placebo

Drug

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.

Primary outcomes

  1. Severity of ADHD core symptoms

    Time frame: 3 months

    Conners Adult ADHD Rating Scale, range 0-78, higher score indicates worse outcome

Secondary outcomes

  1. Number of acute events

    Time frame: 3 months

    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

  2. Score of risk of recidivism

    Time frame: 3 months

    Dynamic risk assessment tool will be used to evaluate the risk of recidivism, score 0-30, higher score indicates better outcome

  3. Percentage of adherence to medication

    Time frame: 3 months and 12 months in outpatient care

    Binary variable (yes=adherence to medication, no=absence of adherence to medication)

  4. Percentage of retention to study

    Time frame: 12 months in outpatient care

    Binary variable (yes=remain in the study, no=dropout from the study)

  5. Costs

    Time frame: 3 months (medical and prison-related costs) and 12 months in outpatient care (prison-related 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.

  6. Number of rule-breaking events

    Time frame: 12 months in outpatient care

    Composite outcome with sanctions recorded in prison and recidivism from the official Swiss criminal records (Federal Office of Statistics, Criminal Conviction Statistics) after release, binary variable (yes=rule-breaking behaviour, no=no rule-breaking behaviour)

Other outcomes

  1. Number of side effects

    Time frame: 3 months

    Side effects according to the Swiss compendium (number of side effects)

Sponsors and collaborators

Lead sponsor

Stéphanie Baggio

Other

Collaborators

  • Netherlands Institute for the Study of Crime and Law Enforcement
  • School of Health Sciences Fribourg
  • University of Geneva, Switzerland
  • University of Lausanne

Registry information

Official study title

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

Acronym: BATIR

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 6, 2023
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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