Randomised controlled trial of the short term effects of OROS-methylphenidate on ADHD symptoms and behavioral outcomes in young male prisoners with attention-deficit/hyperactivity disorder

We proposed to conduct an 8-week randomised placebo controlled trial of OROS-MPH in young male prisoners meeting diagnostic criteria for ADHD. The study will be conducted at HMYOI Polmont (ages 16-21) and HMYOI Isis (ages 18-25). Primary hypothesis is that OROS-MPH compared to placebo reduces ADHD symptoms in young offenders meeting diagnostic criteria for ADHD. Secondary hypotheses evaluate improvements in function and behaviour and whether these improvements are mediated by reductions in ADHD symptoms. The primary research question is critical because many other states, besides ADHD, are associated with inattentive, restless and impulsive behaviour in forensic populations (e.g. personality disorder, anxiety, post-traumatic stress and substance misuse). It remains unknown whether offenders meeting symptom criteria for ADHD show the same clinical response to OROS-MPH reported in community samples. Currently, ADHD is rarely treated in offender populations because of concerns about the efficacy and safety of OROS-MPH or other stimulant medications in prisoners. Participants will be 200 male prisoners meeting DSM-5 criteria for ADHD. The primary outcome will be investigator rated ADHD symptoms. Secondary outcomes will be emotional dysregulation (anger, temper and emotional volatility), attitude towards violence (a predictor of violent behaviour), number of antisocial incidents recorded by prison staff, behavioural ratings from prison staff and engagement with education and rehabilitation programs. Participants aged 16-25 will have at least 4 months sentence remaining. Exclusion criteria include current treatment for ADHD and history of major mental illness (e.g. schizophrenia, bipolar I disorder). Following the same procedures as our feasibility study, prisoners will be screened for ADHD using a self-rated ADHD rating scale. Screen positive cases will complete the Diagnostic Interview for Adult ADHD (DIVA) followed by a developmental and psychiatric assessment by a clinician trained in the diagnosis of ADHD. Medication will be titrated from 18-72 mg in weeks 1-5 to maximise control of ADHD symptoms and minimise adverse effects. Endpoint measures will be completed after 8 weeks. Power calculation is based on data from an open-label pre-post study using similar procedures. We observed an average 46% decline in ADHD symptoms. Assuming that 20% of the effect is due to OROS-MPH, the study is powered to detect an effect of d=0.55, consistent with the average effect size from meta-analyses of MPH studies in adult ADHD. Assuming a maximum 25% loss to follow-up, a sample of 100 is required in each arm for >90% power at an alpha of 0.05. In the pilot, loss at random resulted from unexpected release or prison transfers, unrelated to change in recent behaviour. Assuming a 50% lower recruitment rate in a placebo controlled trial, pilot data suggests 3% of the screened population in ISIS and 5% in Polmont, will enter the trial. With an initial cohort of 1557 subjects plus 40 new prisoners a month in Polmont and 110 in ISIS, we envisage completing recruitment within 30 months. Economic benefits are expected from reduced prison costs and fewer interventions for injuries and clinical impairments (e.g. emotional instability, restlessness, sleep problems). Long term savings are envisaged from reduced recidivism, mental health comorbidities and greater social integration.