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Training attention in children with acquired brain injury: a study protocol of a randomised controlled trial of the TALI attention training programme.

ABSTRACT: INTRODUCTION:Childhood inattention has been linked with poor academic outcomes, and increased lifetime social, occupational and psychiatric morbidity. Children with an acquired brain injury (ABI) are particularly susceptible to attention deficits and may benefit from interventions aimed at enhancing attention. The primary objective of this study is to evaluate the short-term efficacy of the TALI Train programme, compared with a placebo, on the outcome of attention in children with ABI. METHODS AND ANALYSIS:The study is a parallel, double-blind, randomised controlled trial. Participants will consist of 80 children with a diagnosis of ABI aged 4-9 years 11 months. Participants will be randomly allocated to either (1) TALI Train (intervention group), an adaptive game-based attention training programme, or (2) a non-adaptive placebo programme (control group). Both programmes are delivered on a touchscreen tablet, and children complete five 20 min sessions per week for a 5-week period at home. Assessment of selective, sustained and executive attention (primary outcomes), and behavioural attention, working memory, social skills and mathematics ability (secondary outcomes) will occur at baseline, post-training, and at 3-month and 6-month follow-up to assess immediate and long-term efficacy of TALI Train compared with placebo. Assessments will be completed at the Royal Children's Hospital in Melbourne, Australia. All assessments and analyses will be undertaken by researchers blinded to group membership. Latent growth curve modelling will be employed to examine primary and secondary outcomes. ETHICS AND DISSEMINATION:Ethics approval has been obtained from the Royal Children's Hospital Human Research Ethics Committee (HREC) (38132) and the Monash University HREC (17446). Results will be disseminated through peer-reviewed journals, conference presentations, media outlets, the internet and various community/stakeholder activities. TRIAL REGISTRATION NUMBER:ACTRN12619000511134.

SUBMITTER: McKay E

PROVIDER: S-EPMC6924822 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Training attention in children with acquired brain injury: a study protocol of a randomised controlled trial of the TALI attention training programme.

McKay Erin E Richmond Sally S Kirk Hannah H Anderson Vicki V Catroppa Cathy C Cornish Kim K

BMJ open 20191204 12

<h4>Introduction</h4>Childhood inattention has been linked with poor academic outcomes, and increased lifetime social, occupational and psychiatric morbidity. Children with an acquired brain injury (ABI) are particularly susceptible to attention deficits and may benefit from interventions aimed at enhancing attention. The primary objective of this study is to evaluate the short-term efficacy of the TALI Train programme, compared with a placebo, on the outcome of attention in children with ABI.<h ...[more]

PMID: 31806614

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Project description:IntroductionCompromised integrity of the brain due to paediatric acquired brain injury (pABI) has been associated with cognitive impairment, particularly executive dysfunction, in addition to somatic and emotional symptoms and reduced everyday function. Goal Management Training (GMT) is a cognitive rehabilitation intervention for improving executive function (EF) that has received empirical support in studies of adults with ABI. The purpose of the present study is to determine the efficacy of a recently developed paediatric version of GMT (pGMT) for children and adolescents with ABI and reported executive dysfunction.Methods and analysisThis study protocol describes a parallel randomised controlled trial including allocation concealment and assessor blinding. Eighty survivors after pABI, aged 10-17 years at the time of intervention, will be recruited. Participants will be randomly allocated to either pGMT (n=40) or a psychoeducative control intervention (n=40; paediatric Brain Health Workshop). Both interventions consist of seven group sessions for participants and parents, followed by external cueing and telephone counselling. The study also includes involvement of teachers. Assessments will be performed at baseline, immediately postintervention and at 6 months' follow-up. Primary outcome measure will be changes in daily life EF as reported by parents (The Behavior Rating Inventory of Executive Function). Secondary outcomes include other assessments of EF (neuropsychological tests and questionnaires). Furthermore, we aim to assess generalisation effects of pGMT on other cognitive functions, as well as emotional, behavioural, adaptive and family function, academic performance, fatigue and quality of life.Ethics and disseminationResults from this study will be disseminated to relevant research, clinical, health service and patient communities through publications in peer-reviewed and popular science journals, in addition to presentations at scientific conferences. The study will be conducted in accordance with the Helsinki declaration and the Ethical Research Involving Children (ChildWatch International and Unicef). In accordance to Good Clinical Practice our study includes safety and quality monitoring guarantees in compliance with research ethics and safety. The trial will be reported in accordance with the Consolidated Standards of Reporting Trials 2010 statement and Standard Protocol Items for Reporting in Trials recommendations, in addition to being registered at ClinicalTrials.gov. The study has been approved by the Regional Committees for Medical and Health Research Ethics Norway (2017/772).Trial registration numberNCT03215342.

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:ObjectivesTo measure the clinical, structural and functional changes of an individualised structured cognitive rehabilitation in mild traumatic brain injury (mTBI) population.SettingA single centre study, Malaysia.ParticipantsAdults aged between 18 and 60 years with mTBI as a result of road traffic accident, with no previous history of head trauma, minimum of 9 years education and abnormal cognition at 3 months will be included. The exclusion criteria include pre-existing chronic illness or neurological/psychiatric condition, long-term medication that affects cognitive/psychological status, clinical evidence of substance intoxication at the time of injury and major polytrauma. Based on multiple estimated calculations, the minimum intended sample size is 50 participants (Cohen's d effect size=0.35; alpha level of 0.05; 85% power to detect statistical significance; 40% attrition rate).InterventionsIntervention group will receive individualised structured cognitive rehabilitation. Control group will receive the best patient-centred care for attention disorders. Therapy frequency for both groups will be 1 hour per week for 12 weeks.Outcome measuresPrimary: Neuropsychological Assessment Battery-Screening Module (S-NAB) scores. Secondary: Diffusion Tensor Imaging (DTI) parameters and Goal Attainment Scaling score (GAS).ResultsResults will include descriptive statistics of population demographics, CogniPlus cognitive program and metacognitive strategies. The effect of intervention will be the effect size of S-NAB scores and mean GAS T scores. DTI parameters will be compared between groups via repeated measure analysis. Correlation analysis of outcome measures will be calculated using Pearson's correlation coefficient.ConclusionThis is a complex clinical intervention with multiple outcome measures to provide a comprehensive evidence-based treatment model.Ethics and disseminationThe study protocol was approved by the Medical Research Ethics Committee UMMC (MREC ID NO: 2016928-4293). The findings of the trial will be disseminated through peer-reviewed journals and scientific conferences.Trial registration numberNCT03237676.

Project description:BackgroundTraumatic brain injury is a leading cause of death and disability worldwide. Laboratory and clinical studies demonstrate a possible beneficial effect of erythropoietin in improving outcomes in the traumatic brain injury cohort. However, there are concerns regarding the association of erythropoietin and thrombosis in the critically ill. A large-scale, multi-centre, blinded, parallel-group, placebo-controlled, randomised trial is currently underway to address this hypothesis.Methods/designThe erythropoietin in traumatic brain injury trial is a stratified prospective, multi-centre, randomised, blinded, parallel-group, placebo-controlled phase III trial. It aims to determine whether the administration of erythropoietin compared to placebo improves neurological outcome in patients with moderate or severe traumatic brain injury at six months after injury. The trial is designed to recruit 606 patients between 15 and 65 years of age with severe (Glasgow Coma Score: 3 to 8) or moderate (Glasgow Coma Score: 9 to 12) traumatic brain injury in Australia, New Zealand, Kingdom of Saudi Arabia, France, Finland, Germany and Ireland. Trial patients will receive either subcutaneous erythropoietin or placebo within 24 hours of injury, and weekly thereafter for up to three doses during the intensive care unit admission. The primary outcome will be the combined proportion of unfavourable neurological outcomes at six months: severe disability or death. Secondary outcomes will include the rate of proximal deep venous thrombosis detected by compression Doppler ultrasound, six-month mortality, the proportion of patients with composite vascular events (deep venous thrombosis, pulmonary embolism, myocardial infarction, cardiac arrest and cerebrovascular events) at six months and quality of life with health economic evaluations.DiscussionWhen completed, the trial aims to provide evidence on the efficacy and safety of erythropoietin in traumatic brain injury patients, and to provide clear guidance for clinicians in their management of this devastating condition.Trial registrationAustralian New Zealand Clinical Trials registry: ACTRN12609000827235 (registered on 22 September 2009). Clinicaltrials.gov: NCT00987454 (registered on 29 September 2009). European Drug Regulatory Authorities Clinical Trials: 2011-005235-22 (registered on 18 January 2012).

Project description:INTRODUCTION:Two-wheel bike riding can be a goal for children with cerebral palsy (CP) and a means of participating in physical activity. It is possible for some children with CP to ride a two-wheel bike; however, currently far fewer can ride compared with their typically developing peers. Evidence supports training targeted towards goals of the child with CP and their family; yet there is little evidence to guide best-practice bike skills training. Task-specific training may lead to attainment of two-wheel bike-specific goals. This study aims to determine if a novel task-specific approach to training two-wheel bike skills is more effective than a parent-led home programme for attaining individualised two-wheel bike-specific goals in independently ambulant children with CP aged 6-15 years. METHODS AND ANALYSIS:Sixty eligible children with CP (Gross Motor Function Classification System levels I-II) aged 6-15 years with goals relating to riding a two-wheel bike will be randomised to either a novel task-specific centre-based group programme (intervention) or a parent-led home-based programme (comparison), both involving a 1-week intervention period. The primary outcome is goal attainment in the week following the intervention period (T1). Secondary outcomes include: goal attainment and participation in physical activity at 3?months postintervention (T2) and bike skills, attendance and involvement in bike riding, self-perception and functional skills at T1 and T2. Economic appraisal will involve cost-effectiveness and cost-utility analyses. Adherence of clinicians and parents to the intervention and comparison protocols will be assessed. Linear and logistic regression will be used to assess the effect of the intervention, adjusted for site as used in the randomisation process. ETHICS AND DISSEMINATION:This study was approved by the Human Research and Ethics Committees at The Royal Children's Hospital (#36209). Results will be disseminated via peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER:NCT03003026; Pre-results.

Project description:IntroductionChildren with cerebral palsy (CP) experience declines in gross motor ability as they transition from childhood to adolescence, which can result in the loss of ability to perform sit-to-stand transfers, ambulate or participate in leisure activities such as cycling. Functional electrical stimulation (FES) cycling is a novel technology that may provide opportunities for children with CP to strengthen their lower limbs, improve functional independence and increase physical activity participation. The proposed randomised controlled trial will test the efficacy of a training package of FES cycling, adapted cycling and goal-directed functional training to usual care in children with CP who are susceptible to functional declines.Methods and analysisForty children with CP (20 per group), aged 6-8 years and classified as Gross Motor Function Classification System (GMFCS) levels II-IV will be recruited across South East Queensland. Participants will be randomised to either an immediate intervention group, who will undertake 8?weeks of training, or a waitlist control group. The training group will attend two 1?hour sessions per week with a physiotherapist, consisting of FES cycling and goal-directed, functional exercises and a 1?hour home exercise programme per week, consisting of recreational cycling. Primary outcomes will be the gross motor function measure and Canadian occupational performance measure, and secondary outcomes will include the five times sit-to-stand test, habitual physical activity (accelerometry), power output during cycling and Participation and Environment Measure-Children and Youth. Outcomes will be assessed at baseline, postintervention (8 weeks) and 8 weeks following the intervention (retention).Ethics and disseminationEthical approval has been obtained from Griffith University (2018/037) and the Children's Health Queensland Hospital and Health Service (CHQHHS) Human Research Ethics Committee (HREC/17/QRCH/88). Site-specific approval was obtained from CHQHHS research governance (SSA/17/QRCH/145). Results from this trial will be disseminated via publication in relevant peer-reviewed journals.Trial registration numberACTRN12617000644369p.

Project description:IntroductionSocial communication difficulties (SCDs) occur frequently after an acquired brain injury (ABI) and have disabling consequences, but effective interventions are scant. Group Interactive Structured Treatment (GIST) is a holistic group treatment targeting SCD that has received empirical support.ObjectiveTo determine the efficacy of two GIST protocols, standard GIST and a newly developed intensive GIST, comparing standard GIST results to a wait-list control group (WL), as well as to intensive GIST received by participants following WL. The within subject results for WL and intensive GIST will also be examined.Methods and analysisSixty adults (18-75 years) with SCD after ABI will be recruited for this randomised controlled trial. Standard GIST (n=30) will be delivered via outpatient sessions for 2.5 hours once per week for 12 weeks, plus one initial orientation session. Participants will be assessed at preintervention and postintervention and at 3-month and 6-month follow-ups (T1-T4). Intensive GIST (n=30) participants will be admitted to an inpatient rehabilitation unit for 4 weeks (two times 3 days/week, two times 4 days/week) and receive full-day sessions each week. Those participants will complete four assessments (T1-T4) in 12-week intervals as part of WL, assessments preintensive and postintensive GIST and at 3-month and 6-month follow-ups (T4-T7). The primary outcome measure is the La Trobe Questionnaire (self-report). Secondary outcome measures include the Profile of Pragmatic Impairment in Communication, a test of emotion recognition, the Goal Attainment Scale and questionnaires addressing social, emotional and cognitive functions, self-efficacy and quality of life.Ethics and disseminationResults will be communicated through international, peer-reviewed and popular science journals and presentations at scientific conferences. The study is approved by the Regional Committees for Medical and Health Research Ethics Norway (2017/1360). The trial will be conducted in accordance with the Declaration of Helsinki and reported in accordance with the Consolidated Standards of Reporting Trials 2010 statement and Standard Protocol Items: Recommendations for Interventional Trials recommendations.Trial registration numberNCT03636399.

Project description:BackgroundMild traumatic brain injury (mTBI) is an acknowledged public health problem. Up to 25% of adult with mTBI present persistent symptoms. Headache, dizziness, nausea and neck pain are the most commonly reported symptoms and are frequently associated with cervical spine and vestibular impairments. The most recent international consensus statement (2017 Berlin consensus) recommends the addition of an individualized rehabilitation approach for mTBI with persistent symptoms. The addition of an individualized rehabilitation approach including the evaluation and treatment of cervical and vestibular impairments leading to symptoms such as neck pain, headache and dizziness is, however, recommended based only on limited scientific evidence. The benefit of such intervention should therefore be further investigated.ObjectiveTo compare the addition of a 6-week individualized cervicovestibular rehabilitation program to a conventional approach of gradual sub-threshold physical activation (SPA) alone in adults with persistent headache, neck pain and/or dizziness-related following a mTBI on the severity of symptoms and on other indicators of clinical recovery. We hypothesize that such a program will improve all outcomes faster than a conventional approach (between-group differences at 6-week and 12-week).MethodsIn this single-blind, parallel-group randomized controlled trial, 46 adults with subacute (3 to12 weeks post-injury) persistent mTBI symptoms will be randomly assigned to: 1) a 6-week SPA program or 2) SPA combined with a cervicovestibular rehabilitation program. The cervicovestibular rehabilitation program will include education, cervical spine manual therapy and exercises, vestibular rehabilitation and home exercises. All participants will take part in 4 evaluation sessions (baseline, week 6, 12 and 26) performed by a blinded evaluator. The primary outcome will be the Post-Concussion Symptoms Scale. The secondary outcomes will be time to clearance to return to function, number of recurrent episodes, Global Rating of Change, Numerical Pain Rating Scale, Neck Disability Index, Headache Disability Inventory and Dizziness Handicap Inventory. A 2-way ANOVA and an intention-to-treat analysis will be used.DiscussionControlled trials are needed to determine the best rehabilitation approach for mTBI with persistent symptoms such as neck pain, headache and dizziness. This RCT will be crucial to guide future clinical management recommendations.Trial registrationClinicalTrials.gov Identifier - NCT03677661, Registered on September, 15th 2018.

Project description:IntroductionCerebral palsy (CP) is the most common cause of physical disability in children, with an estimated 600-700 infants born with CP in Australia each year. CP is typically associated with motor impairments, but nearly half of all children with CP also experience cognitive impairment, potentially impacting educational and vocational achievement. This paper reports the protocol for a randomised controlled trial of a computerised cognitive training intervention based on behavioural principles: Strengthening Mental Abilities through Relational Training (SMART). The study aims to investigate SMART's effect on fluid reasoning, executive function and academic achievement in children with CP.Methods and analysisSixty children with mild to moderate CP (Gross Motor Function Classification Scale I-IV) aged between 8 years and 12 years will be recruited. Participants will be randomly allocated to two groups: SMART cognitive training and waitlist control. Families will access the programme at home over a 4-month period. Assessments will be administered at baseline, 20 weeks and at 40 week follow-up for retention. The primary outcome will be fluid intelligence, while academic achievement, executive function and social and emotional well-being will be secondary outcomes.Ethics and disseminationThis study has approval from the Children's Health Queensland Hospital and Health Service Research Ethics Committee (HREC/14/QRCH/377) and The University of Queensland (2017001806). If the computerised cognitive training programme is found to be effective, dissemination of these findings would assist children with CP by providing an accessible, cost-effective intervention that can be completed at home at the individual's own pace.Registration detailsThe study was registered prospectively on 10 November 2017 to present. Recruitment is now under way, and we aim to complete recruitment by June 2019, with data collection finalised by March 2020.Trial registration numberACTRN12617001550392; Pre-results.

Dataset Information

Training attention in children with acquired brain injury: a study protocol of a randomised controlled trial of the TALI attention training programme.

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Training attention in children with acquired brain injury: a study protocol of a randomised controlled trial of the TALI attention training programme.

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