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Cognitive behavioural therapy in groups for medicated adults with attention deficit hyperactivity disorder: protocol for a randomised controlled trial

ABSTRACT: Introduction Cognitive behavioural therapy (CBT) is an evidence-based treatment for adults with attention deficit hyperactivity disorder (ADHD). However, it is still inconsistent whether a combination of CBT would have additive effects in medicated ADHD in adulthood. And if CBT would have additional effects, what kind and which dimension would CBT play a part? This study estimates the efficacy of CBT in stable medicated adult ADHD, using long-term outcomes and multidimensional evaluations. Methods and analysis It is a two-armed, randomised controlled trial on the superiority of the efficacy of 12 weeks of CBT on medicated adult ADHD. We compare the short-term and long-term outcomes between CBT combined with medication (CBT+M) group and the medication-only (M) group, including ADHD core symptoms, emotional symptoms, executive function, self-esteem, life quality and brain function using functional near-infrared spectroscopy data. Participants are outpatients of the Peking University Sixth Hospital and those recruited online, diagnosed as adult ADHD and with stable medication treatment. We estimate ADHD core symptoms and combined symptoms at baseline (T1) and week 12 (T2), week 24 (T3), week 36 (T4) and week 48 (T5). Ethics and dissemination This trial has been approved by the Ethics and Clinical Research Committees of Peking University Sixth Hospital and will be performed under the Declaration of Helsinki with the Medical Research Involving Human Subjects Act (WMO). The results will be disseminated in a peer-reviewed journal and a conference presentation. Trial registration number ChiCTR (ChiCTR1900021705).

SUBMITTER: Pan M

PROVIDER: S-EPMC7537466 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Project description:IntroductionAttention-deficit/hyperactivity disorder (ADHD) is one of the most prevalent neurodevelopmental disorders and is a persistent pattern of inattention and/or hyperactivity-impulsivity that interferes with daily functioning. Children with ADHD are developmentally vulnerable, with the disorder linked to emotional regulation difficulties, behavioural disturbances, as well as academic challenges. Emerging evidence suggests that children with ADHD may benefit from cognitive training interventions, including those focused on attention. This study aims to assess the immediate and long-term efficacy of an attention training intervention in children with ADHD.Methods and analysisThis study is a preregistered, parallel, double blind, randomised controlled trial. Participants will comprise 104 children with a diagnosis of ADHD aged 5-8 years 11 months. Participants will be randomly allocated to either an adaptive, digital game-based (1) attention training programme (intervention) or (2) a numeracy programme (control). Both programmes will be delivered on a touchscreen tablet, and children will complete five 20 min sessions per week for a 5-week period at home (25 sessions in total). Assessments of the primary outcome (ie, attention and inhibitory control) and secondary outcomes (ie, selective attention, interference control, sustained attention, inhibition, behavioural attention, impairment in everyday functioning, working memory and executive functioning) will occur at preintervention, immediately postintervention and at 3-month follow-up. Multivariate linear regression will be employed to examine primary and secondary outcomes. The data analyst will be blinded to group membership.Ethics and disseminationEthics approval has been obtained from the Monash University HREC (20495). Results will be disseminated through peer-reviewed journals, conference presentations, media outlets, the internet and various community/stakeholder activities.Trial registration numberACTRN12620000964910, UTN U1111-1250-2620.

Project description:IntroductionChildren with attention-deficit/hyperactivity disorder (ADHD) commonly experience behavioural sleep problems, yet these difficulties are not routinely assessed and managed in this group. Presenting with similar symptoms to ADHD itself, sleep problems are complex in children with ADHD and their aetiology is likely to be multifactorial. Common internalising and externalising comorbidities have been associated with sleep problems in children with ADHD; however, this relationship is yet to be fully elucidated. Furthermore, limited longitudinal data exist on sleep problems in children with ADHD, thus their persistence and impact remain unknown. In a diverse sample of children with ADHD, this study aims to: (1) quantify the relationship between sleep problems and internalising and externalising comorbidities; (2) examine sleep problem trajectories and risk factors; and (3) examine the longitudinal associations between sleep problems and child and family functioning over a 12-month period.Methods and analysisA prospective cohort study of 400 children with ADHD (150 with no/mild sleep problems, 250 with moderate/severe sleep problems) recruited from paediatric practices across Victoria, Australia. The children's parents and teacher provide data at baseline and 6-month and 12-month post enrolment.Key measuresParent report of child's sleep problem severity (no, mild, moderate, severe); specific sleep domain scores assessed using the Child Sleep Habits Questionnaire; internalising and externalising comorbidities assessed by the Anxiety Disorders Interview Schedule for Children IV/Parent version.AnalysesMultiple variable logistic and linear regression models examining the associations between key measures, adjusted for confounders identified a priori.Ethics and disseminationEthics approval has been granted. Findings will contribute to our understanding of behavioural sleep problems in children with ADHD. Clinically, they could improve the assessment and management of sleep problems in this group. We will seek to publish in leading paediatric journals, present at conferences and inform Australian paediatricians through the Australian Paediatric Research Network.

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Cognitive behavioural therapy in groups for medicated adults with attention deficit hyperactivity disorder: protocol for a randomised controlled trial

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