scholarly journals Randomised controlled trial of the short-term effects of OROS-methylphenidate on ADHD symptoms and behavioural outcomes in young male prisoners with attention-deficit/hyperactivity disorder (CIAO-II)

2019 ◽  
Author(s):  
Philip Asherson ◽  
Lena Johansson ◽  
Rachel Holland ◽  
Thomas Fahy ◽  
Andrew Forester ◽  
...  
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Attention Deficit ◽  
Controlled Trial ◽  
Young Male ◽  
Emotional Dysregulation ◽  
Adhd Symptoms ◽  
Short Term ◽  
Hyperactivity Disorder ◽  
Randomised Controlled ◽  
Male Prisoners

Abstract Background: Attention-deficit/hyperactivity disorder (ADHD) is a highly prevalence disorder, seen in 20-30% of young adult prisoners. Pharmacoepidemiological studies, a small randomised controlled, and open trial data suggest clinically significant reductions in ADHD symptoms, emotional dysregulation, disruptive behaviour and engagement with educational activities. Yet, routine treatment of ADHD in offenders with ADHD is not yet established clinical practice. There is continued uncertainty about the clinical response to methylphenidate, a first line treatment for ADHD, in offenders who often present with an array of complex mental health problems that may better explain states of inattentive, overactive restless and impulsive behaviours. To address this problem we conduct an efficacy trial to establish the short term effects of OROS-methylphenidate (Concerta XL), an extended release formulation of MPH, on ADHD symptoms, emotional dysregulation and behaviour. Methods: Parallel arm randomised placebo-controlled trial of OROS-MPH on ADHD symptoms, behaviour and functional outcomes in young male prisoners aged 16-25, meeting DSM-5 criteria for ADHD. Participants are randomised to 8-weeks treatment with OROS-MPH or placebo, titrated over 5 weeks to balance ADHD symptom improvement against side effects. 200 participants will be recruited with 1:1 ratio of drug to placebo. The primary outcome is change in level of ADHD symptoms after 8-weeks of trial medication. Discussion: Potential benefits include improvement in ADHD symptoms, emotional dysregulation, attitudes towards violence, critical incidents and engagement with educational and rehabilitation programs. Demonstrating efficacy and safety of MPH on ADHD symptoms and associated impairments may provide the data needed to develop effective healthcare pathways for a significant group of young offenders. Establishing efficacy of MPH in this population will provide the foundation needed to establish long term effectiveness studies with the potential for demonstrating significant reductions in criminal behaviour and improved health-economic outcomes. Trial Registration: ISRCTN16827947l; EudraCT Number: 2015-004271-78. Protocol version: v2.0 30.08.2018

scholarly journals Randomised controlled trial of the short-term effects of OROS-methylphenidate on ADHD symptoms and behavioural outcomes in young male prisoners with attention-deficit/hyperactivity disorder (CIAO-II)

2019 ◽  
Author(s):  
Philip Asherson ◽  
Lena Johansson ◽  
Rachel Holland ◽  
Thomas Fahy ◽  
Andrew Forester ◽  
...  
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Attention Deficit ◽  
Controlled Trial ◽  
Young Male ◽  
Emotional Dysregulation ◽  
Adhd Symptoms ◽  
Short Term ◽  
Hyperactivity Disorder ◽  
Randomised Controlled ◽  
Male Prisoners

Abstract Background: Attention-deficit/hyperactivity disorder (ADHD) is a highly prevalence disorder, seen in 20-30% of young adult prisoners. Pharmacoepidemiological studies, a small randomised controlled, and open trial data suggest clinically significant reductions in ADHD symptoms, emotional dysregulation, disruptive behaviour and engagement with educational activities. Yet, routine treatment of ADHD in offenders with ADHD is not yet established clinical practice. There is continued uncertainty about the clinical response to methylphenidate, a first line treatment for ADHD, in offenders who often present with an array of complex mental health problems that may better explain states of inattentive, overactive restless and impulsive behaviours. To address this problem we conduct an efficacy trial to establish the short term effects of OROS-methylphenidate (Concerta XL), an extended release formulation of MPH, on ADHD symptoms, emotional dysregulation and behaviour. Methods: Parallel arm randomised placebo-controlled trial of OROS-MPH on ADHD symptoms, behaviour and functional outcomes in young male prisoners aged 16-25, meeting DSM-5 criteria for ADHD. Participants are randomised to 8-weeks treatment with OROS-MPH or placebo, titrated over 5 weeks to balance ADHD symptom improvement against side effects. 200 participants will be recruited with 1:1 ratio of drug to placebo. The primary outcome is change in level of ADHD symptoms after 8-weeks of trial medication. Discussion: Potential benefits include improvement in ADHD symptoms, emotional dysregulation, attitudes towards violence, critical incidents and engagement with educational and rehabilitation programs. Demonstrating efficacy and safety of MPH on ADHD symptoms and associated impairments may provide the data needed to develop effective healthcare pathways for a significant group of young offenders. Establishing efficacy of MPH in this population will provide the foundation needed to establish long term effectiveness studies with the potential for demonstrating significant reductions in criminal behaviour and improved health-economic outcomes. Trial Registration: ISRCTN16827947l; EudraCT Number: 2015-004271-78. Protocol version: v2.0 30.08.2018

scholarly journals Randomised controlled trial of the short-term effects of OROS-methylphenidate on ADHD symptoms and behavioural outcomes in young male prisoners with attention-deficit/hyperactivity disorder (CIAO-II)

2019 ◽  
Author(s):  
Philip Asherson ◽  
Lena Johansson ◽  
Rachel Holland ◽  
Thomas Fahy ◽  
Andrew Forester ◽  
...  
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Attention Deficit ◽  
Controlled Trial ◽  
Young Male ◽  
Emotional Dysregulation ◽  
Adhd Symptoms ◽  
Short Term ◽  
Hyperactivity Disorder ◽  
Randomised Controlled ◽  
Male Prisoners

Abstract Background: Attention-deficit/hyperactivity disorder (ADHD) is a highly prevalence disorder, seen in 20-30% of young adult prisoners. Pharmacoepidemiological studies, a small randomised controlled, and open trial data suggest clinically significant reductions in ADHD symptoms, emotional dysregulation, disruptive behaviour and engagement with educational activities. Yet, routine treatment of ADHD in offenders with ADHD is not yet established clinical practice. There is continued uncertainty about the clinical response to methylphenidate, a first line treatment for ADHD, in offenders who often present with an array of complex mental health problems that may better explain states of inattentive, overactive restless and impulsive behaviours. To address this problem we conduct an efficacy trial to establish the short term effects of OROS-methylphenidate (Concerta XL), an extended release formulation of MPH, on ADHD symptoms, emotional dysregulation and behaviour. Methods: Parallel arm randomised placebo-controlled trial of OROS-MPH on ADHD symptoms, behaviour and functional outcomes in young male prisoners aged 16-25, meeting DSM-5 criteria for ADHD. Participants are randomised to 8-weeks treatment with OROS-MPH or placebo, titrated over 5 weeks to balance ADHD symptom improvement against side effects. 200 participants will be recruited with 1:1 ratio of drug to placebo. The primary outcome is change in level of ADHD symptoms after 8-weeks of trial medication. Discussion: Potential benefits include improvement in ADHD symptoms, emotional dysregulation, attitudes towards violence, critical incidents and engagement with educational and rehabilitation programs. Demonstrating efficacy and safety of MPH on ADHD symptoms and associated impairments may provide the data needed to develop effective healthcare pathways for a significant group of young offenders. Establishing efficacy of MPH in this population will provide the foundation needed to establish long term effectiveness studies with the potential for demonstrating significant reductions in criminal behaviour and improved health-economic outcomes. Trial Registration: ISRCTN16827947l; EudraCT Number: 2015-004271-78. Protocol version: v2.0 30.08.2018

scholarly journals Randomised controlled trial of the short-term effects of OROS-methylphenidate on ADHD symptoms and behavioural outcomes in young male prisoners with attention-deficit/hyperactivity disorder (CIAO-II)

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Philip Asherson ◽  
Lena Johansson ◽  
Rachel Holland ◽  
Tom Fahy ◽  
Andrew Forester ◽  
...  
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Young Male ◽  
Emotional Dysregulation ◽  
Adhd Symptoms ◽  
Short Term ◽  
Hyperactivity Disorder ◽  
Randomised Controlled ◽  
Male Prisoners

Abstract Background Attention-deficit/hyperactivity disorder (ADHD) is a highly prevalent disorder, seen in 20–30% of young adult prisoners. Pharmacoepidemiological studies, a small randomised controlled trial and open trial data of methylphenidate suggest clinically significant reductions in ADHD symptoms, emotional dysregulation, disruptive behaviour and increased engagement with educational activities. Yet, routine treatment of ADHD in offenders is not yet established clinical practice. There is continued uncertainty about the clinical response to methylphenidate (MPH), a first-line treatment for ADHD, in offenders, who often present with an array of complex mental health problems that may be better explained by states of inattentive, overactive, restless and impulsive behaviours. To address this problem, we will conduct an efficacy trial to establish the short-term effects of osmotic-controlled release oral delivery system (OROS)-methylphenidate (Concerta XL), an extended release formulation of MPH, on ADHD symptoms, emotional dysregulation and behaviour. Methods This study is a parallel-arm, randomised, placebo-controlled trial of OROS-MPH on ADHD symptoms, behaviour and functional outcomes in young male prisoners aged 16–25, meeting Diagnostic and Statistical Manual of Mental Disorders, fifth edition criteria for ADHD. Participants are randomised to 8 weeks of treatment with OROS-MPH or placebo, titrated over 5 weeks to balance ADHD symptom improvement against side effects. Two hundred participants will be recruited with a 1:1 ratio of drug to placebo. The primary outcome is change in level of ADHD symptoms after 8 weeks of trial medication. Discussion Potential benefits include improvement in ADHD symptoms, emotional dysregulation, attitudes towards violence and critical incidents and increased engagement with educational and rehabilitation programmes. Demonstrating the efficacy and safety of MPH on ADHD symptoms and associated impairments may provide the data needed to develop effective healthcare pathways for a significant group of young offenders. Establishing efficacy of MPH in this population will provide the foundation needed to establish long-term effectiveness studies with the potential for demonstrating significant reductions in criminal behaviour and improved health-economic outcomes. Trial registration ISRCTN registry, ISRCTN16827947, 31st May 2016; EudraCT number, 2015-004271-78, 31st May 2016. Last particpant last visit 6 June 2019. Data lock 27 August 2019.

scholarly journals 1-year follow-up of neurofeedback treatment in adolescents with attention-deficit hyperactivity disorder: randomised controlled trial

BJPsych Open ◽  
2016 ◽  
Vol 2 (2) ◽  
pp. 107-115 ◽  
Author(s):  
Marleen Bink ◽  
Ilja L. Bongers ◽  
Arne Popma ◽  
Tieme W. P. Janssen ◽  
Chijs van Nieuwenhuizen
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Randomised Controlled Trial ◽  
Attention Deficit ◽  
Controlled Trial ◽  
Treatment As Usual ◽  
Hyperactivity Disorder ◽  
Study Results ◽  
Randomised Controlled ◽  
Neurocognitive Measures

BackgroundEstimates of the effectiveness of neurofeedback as a treatment for attention-deficit hyperactivity disorder (ADHD) are mixed.AimsTo investigate the long-term additional effects of neurofeedback (NFB) compared with treatment as usual (TAU) for adolescents with ADHD.MethodUsing a multicentre parallel-randomised controlled trial design, 60 adolescents with a DSM-IV-TR diagnosis of ADHD receiving NFB+TAU (n=41) or TAU (n=19) were followed up. Neurofeedback treatment consisted of approximately 37 sessions of theta/sensorimotor rhythm (SMR)-training on the vertex (Cz). Outcome measures included behavioural self-reports and neurocognitive measures. Allocation to the conditions was unmasked.ResultsAt 1-year follow-up, inattention as reported by adolescents was decreased (range ηp2=0.23–0.36, P<0.01) and performance on neurocognitive tasks was faster (range ηp2=0.20–0.67, P<0.005) irrespective of treatment group.ConclusionsOverall, NFB+TAU was as effective as TAU. Given the absence of robust additional effects of neurofeedback in the current study, results do not support the use of theta/SMR neurofeedback as a treatment for adolescents with ADHD and comorbid disorders in clinical practice.

scholarly journals Pediatric Tuina for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Preschool Children: Study Protocol for a Pilot Randomized Controlled Trial

2020 ◽  
Author(s):  
Shu Cheng Chen ◽  
Juan Yu ◽  
Lorna Kwai-Ping Suen ◽  
Yan Sun ◽  
Ya Zheng Pang ◽  
...  
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Randomized Controlled Trial ◽  
Preschool Children ◽  
Attention Deficit ◽  
Controlled Trial ◽  
Online Training ◽  
Adhd Symptoms ◽  
Hyperactivity Disorder ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Abstract Background: Medication and behavior therapy are the conventional treatments for attention deficit hyperactivity disorder (ADHD), but they have limitations for preschool children. Evidence suggests that pediatric tuina, which is a modality of traditional Chinese medicine, might have beneficial effects on this condition.Objective: To assess the feasibility of conducting an RCT in terms of recruitment, use and acceptability of the parent-administered pediatric tuina for ADHD symptoms in preschoolers.Methods: It is a single-center, two-arm, parallel, open-label, pilot randomized controlled trial (RCT). Sixty children with pre-specified ADHD symptoms (hyperactivity, anxiety, and sleep disturbance) together with one of their parents will be recruited and randomized into two groups at a 1: 1 ratio. Parents in the parent-administered tuina group (intervention group, n=30) will attend an online training program to learn pediatric tuina skills for ADHD symptoms and conduct this treatment on their children at home. Parents in the parent-child interaction group (comparison group, n=30) will attend an online training about progressive muscle relaxation exercise and do this exercise with their children at home. Additional teaching materials will be provided to the participants in both groups. Both interventions should be carried out every other day during a 2-month treatment period, with each time around 20 minutes. Assessment will be performed at baseline, week4, and week 8. The primary outcome measure is the Swanson, Nolan and Pelham Parent Scale; the secondary outcomes include Preschool Anxiety Scale, Children's Sleep Habits Questionnaire, and Parental Stress Scale. A process evaluation embedded within the outcome evaluation will be performed. Differences in the scale scores and test parameters between groups will be examined using a linear mixed-effects model. Qualitative data will be analyzed using thematic content analysis, facilitated by QSR NVivo.Discussion: This study will provide evidence on the acceptability and feasibility of pediatric tuina for ADHD in preschool children. The process evaluation will help to better understand the facilitators and barriers of the intervention functioning.Trial registration: The study was registered at ClinicalTrials.gov (Identifier: NCT04237259) on 14 February 2020.Protocol version: 2, date June 23, 2020

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