Background Impaired executive functions (EFs, i.e., purposeful, goal-directed behaviour) cause significant disability after paediatric acquired brain injury (pABI) warranting efficient interventions. Goal Management Training (GMT) is a metacognitive protocol proven effective for executive dysfunction in adults. This pre-registered, blinded, parallel-randomized controlled trial evaluated efficacy of a paediatric adaptation (pGMT) compared to a psychoeducative control (paediatric Brain Health Workshop, pBHW) to improve EF. Methods Children aged 10 to 17 years with pABI (e.g., traumatic brain injury, brain tumour), ≥ 1 year post-onset or ended treatment, with parent-reported EF complaints were eligible. Participants were randomized (computer-algorithm) to either group-based pGMT (n = 38) or pBHW (n = 38). The active control was tailored to keep non-specific factors constant. Thus, both treatments comprised of 7 sessions at hospitals over 3 consecutive weeks, followed by 4 weeks of telephone counselling of participants, parents, and teachers. Parent-reported daily life EF, assessed by the questionnaire Behavior Rating Inventory of Executive Function (BRIEF; Behavioral Regulation Index (BRI) and Metacognition Index (MI)), were co-primary outcomes 6 months post-intervention. Secondary outcomes included neuropsychological tests and a complex naturalistic task (Children’s Cooking Task). Results Seventy-three participants (96%) completed allocated interventions and 71 (93%) attended the 6-month follow-up. The results demonstrated no significant difference in effectiveness for the two interventions on parent-reported EF: For BRIEFBRI, mean (SD) raw score for pGMT was 42.7 (8.8) and 38.3 (9.3) for pBHW. Estimated difference was − 2.3 (95% CI − 5.1 to 0.6). For BRIEFMI, the corresponding results were 80.9 (20.4) for GMT and 75.5 (19.3) for pBHW. Estimated difference was − 1.4 (95% CI −8.5 to 5.8). In performance-based tests, pGMT was associated with improved inhibition and executive attention, while pBHW was associated with fewer errors in the naturalistic task. Conclusions In pABI, metacognitive training (pGMT) did not demonstrate additional effectiveness on parent-reported daily life EF at 6-month follow-up, when compared to a psychoeducative control. Both interventions were well-tolerated and demonstrated distinct improvements at different EF assessment levels. To conclude on pGMT efficacy, larger studies are needed, including further investigation of appropriate assessment levels and possible differences in effect related to treatment duration, developmental factors, and injury characteristics. Trial registration ClinicalTrials.gov, NCT0321534211, 11 July 2017
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.
Objective. The aims of the present study were to compare fatigue levels in children with pABI with healthy controls (HCs), and examine the interplay of fatigue with associated factors. Method. We used baseline data from a preregistered randomized controlled trial.Seventy-six children aged 10 to 17 (median 13y) with pABI in the chronic phase (88% with confirmatory cerebral imaging findings) and executive function (EF) complaints were included, most with moderate disability according to The Glasgow Outcome Scale Extended (GOSE-E) categorization. HCs consisted of 60 children aged 10 to 17 (median 13y). All 127 participants completed measures of fatigue and IQ. pABI participants were also assessed for behavioral problems, health-related quality of life (HRQoL) and EF. Nonparametric statistics were employed, in addition to a network analysis to model the unique associations between parent-reported fatigue and related factors. Results. Parents reported significantly more fatigue in the pABI-group (75% of scores in clinical range; <70) compared to HCs (11.7% of scores in clinical range). No strong associations were found between fatigue and injury characteristics, but findings indicated more fatigue in the older than younger age-group for pABI participants. Network modeling revealed a central role for HRQoL, behavioral and EF symptoms in relation to fatigue. Conclusions. Fatigue is reported to be highly prevalent in the chronic phase of pABI. When addressing fatigue, our findings demonstrate the advantage of including multidimensional measures of fatigue and examining associated psychological and cognitive constructs, such as HRQoL, behavioral problems and EF.
Background: There are few standardized measures available to assess executive function (EF) in a naturalistic setting for children. The Children’s Cooking Task (CCT) is a complex test that has been specifically developed to assess EF in a standardized open-ended environment (cooking). The aim of the present study was to evaluate the internal consistency, inter-rater reliability, sensitivity and specificity, and also convergent and divergent validity of the Norwegian version of CCT among children with pediatric Acquired Brain Injury (pABI) and healthy controls (HCs).Methods: The present study has a cross-sectional design, based on baseline data derived from a multicenter RCT. Seventy-five children with pABI from two university hospitals with parent-reported executive dysfunction and minimum of 12 months since injury/completed cancer therapy, as well as 59 HCs aged 10–17 years, were assessed with CCT using total errors as the main outcome measure. The pABI group completed tests assessing EF (i.e., inhibition, cognitive flexibility, working memory, and planning) on the impairment level within the ICF framework (performance-based neuropsychological tests and the Behavioral Assessment of the Dysexecutive Syndrome for Children), and on the participation level (questionnaires). In addition, they completed tests of intellectual ability, processing speed, attention, learning, and memory. Finally, overall functional outcome (pediatric Glasgow Outcome Scale-Extended) was evaluated for the children with pABI.Results: Acceptable internal consistency and good inter-rater reliability were found for the CCT. Children with pABI performed significantly worse on the CCT than the HCs. The CCT identified group membership, but the sensitivity and specificity were overall classified as poor. Convergent validity was demonstrated by associations between the CCT and performance-based tests assessing inhibition, cognitive flexibility, and working memory, as well as teacher-reported executive dysfunction (questionnaires). Divergent validity was supported by the lack of association with performance-based measures of learning and memory, attention, and verbal intellectual ability. However, there was a moderate association between the CCT and performance-based tests of processing speed. Lastly, better performance on the CCT was associated with a better functional outcome.Conclusion: Our study with a relatively large sample of children with pABI and HC’s demonstrated good psychometric properties of the CCT. CCT performance was associated with the overall level of disability and function, suggesting that CCT is related to the level of activity in everyday life and participation in society. Hence, our study suggests that the CCT has the potential to advance the assessment of EF by providing a valid analysis of real-world performance. Nevertheless, further research is needed on larger samples, focusing on predictors of task performance, and evaluating the ability of CCT to detect improvement in EF over time. The patterns of error and problem-solving strategies evaluated by the CCT could be used to inform neuropsychological rehabilitation treatmentand represent a more valid outcome measure of rehabilitation interventions.
Girls and boys might differ in autistic symptoms and associated cognitive difficulties such as executive function (EF). We investigated sex differences in the relationship between parent rated EF and autistic symptoms in 116 children and adolescents (25 girls) aged 5–19 years with an intelligence quotient above 70 and an autism spectrum disorder (ASD) diagnosis. They were rated with the behavior rating inventory of executive function (BRIEF) and the autism diagnostic interview revised (ADI-R). We found a positive association between EF and the ADI-R domains of reciprocal social interaction (p < 0.001) and communication (p = 0.001) in girls, while these relationships were small and non-significant in boys. Our results provide a greater understanding of the sex-specific characteristics of children and adolescents with ASD.
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