Telehealth Programme for the Education and Enrichment of Relational Skills (PEERS) for adolescents with acquired and congenital brain injuries: a protocol for mixed-methods randomised trial.BMJ open • February 26, 2025
Leanne Sakzewski, Rose Gilmore, Nicola Hilton, Sarah Goodman, Koa Whittingham, Jacqui Barfoot, Bianca Thompson, Afroz Keramat, Roslyn Boyd
Background: For adolescents with brain injury, challenges with social function often persist into adulthood, impacting social participation and quality of life. The Programme for the Education and Enrichment of Relational Skills (PEERS) is a manualised group-based intervention with preliminary evidence demonstrating improved social knowledge and participation for adolescents with acquired brain injury or cerebral palsy when delivered face to face. The recent COVID-19 pandemic and challenges for families living outside metropolitan centres to access the programme suggest a telehealth delivered PEERS should be explored. This study aims to compare telehealth PEERS to usual care in a mixed-methods randomised waitlist-controlled trial to determine preliminary efficacy to improve social functioning and secondarily to determine acceptability, feasibility, cost and contextual factors impacting the implementation.
Methods: In this single-centre mixed-methods randomised waitlist-controlled trial, 32 adolescents with brain injury, aged 11-17 years attending mainstream high school and their caregivers will be randomised to receive either (a) telehealth PEERS once/week for 1.5 hours for 14 weeks or (b) usual care (UC). UC is highly variable in Australia but often comprises fortnightly occupational therapy, physiotherapy or speech therapy. The waitlist group will then receive PEERS following the 26-week retention time point. Measures will be administered at baseline, 14 weeks (immediately post) and then 26 and 52 weeks post baseline. The primary outcome is self-reported performance and satisfaction with social goals on the Canadian Occupational Performance Measure at 14 weeks. Secondary outcomes include self and parent-reported social competence, frequency of get-togethers with peers, self-report knowledge of social skills, frequency of peer victimisation and quality of life. An implementation evaluation will be done to determine acceptability, feasibility, cost and identify barriers and facilitators in the implementation of the intervention and map these against the Consolidated Framework for Implementation Research. This study will assess the unit costs of implementing the PEERS from an Australian health system perspective. Background: The Children's Health Queensland Hospital and Health Service and The University of Queensland Human Research Ethics Committees have approved this study. Findings will be disseminated in peer-reviewed journals and conference presentations. Background: ACTRN1263000082606.
Active Start Active Future: Feasibility of a Behaviour-Change Intervention to Reduce Sedentary Behaviour and Promote Physical Activity in Young Children with Cerebral Palsy.Physical & Occupational Therapy In Pediatrics • May 26, 2025
Sarah Reedman, Gaela Kilgour, Sjaan Gomersall, Leanne Sakzewski, Stewart Trost, Roslyn Boyd
Children with cerebral palsy (CP) have low physical activity (PA) and high sedentary behavior. The aim was to trial a participation-focused behavior-change intervention to increase PA and decrease sedentary behavior. Twelve children with CP were recruited (mean age 5 years 6 months ± 1 year 2 months, Gross Motor Function Classification System [GMFCS] levels I = 1, II = 1, III = 1, IV = 4, V = 5); eight with complete post-intervention data (mean 5 years 10 months ± 1 year 4 months, GMFCS I = 1, III = 1, IV = 4, V = 2). Children received 8 weekly sessions targeting individualized PA participation goals in a pre-post feasibility trial. Outcomes included: implementation, effectiveness (Canadian Occupational Performance Measure [COPM]), device-measured PA, goal confidence, quality of life, and barriers to PA participation. Semi-structured interviews explored acceptability and were analyzed thematically. Implementation was feasible with ≥90% sessions attended and high enjoyment (89.5%). After 8 wk, COPM goal performance (mean difference [MD] = 2.9, 95% CI 0.7, 5.0; p = 0.02), satisfaction with performance (MD = 3.0, 95% CI 1.6, 4.4; p = 0.002), and confidence (MD = 1.4, 95% CI 0.4, 2.5; p = 0.02) significantly increased with no change in other outcomes. All six caregivers interviewed reported the intervention to be acceptable. Active Start Active Future was feasible to conduct, acceptable and showed preliminary evidence to improve PA in young children with CP.
Study protocol for Active Start Active Future: a randomised control trial of an early behaviour-change intervention targeting physical activity participation and sedentary behaviour in young children with cerebral palsy living in South East Queensland, Australia.BMJ Open • May 19, 2025
Gaela Kilgour, Sarah Reedman, Sjaan Gomersall, Leanne Sakzewski, Stewart Trost, Roslyn Boyd
Background: The benefits of physical activity (PA) are compelling for all ages and abilities. For children with cerebral palsy (CP), two distinct health behaviours, being physically active and reducing sedentary time, are critical to target as an early intervention to reduce long-term morbidity. One approach may be to increase PA participation by empowering parents who are key to making family lifestyle changes. This study will compare Active Start Active Future, a participation-focused intervention, to usual care in a mixed-methods randomised waitlist-controlled trial.
Methods: A total of 40 children with CP (3-7 years), classified in Gross Motor Function Classification System (GMFCS) levels II-V, will be stratified (GMFCS II vs III, IV vs V) and randomised to receive either (1) Active Start Active Future, an 8-week intervention for 1 hour per week in any setting or (2) usual care followed by delayed intervention. Active Start Active Future aims to increase PA and reduce sedentary behaviour of young children with CP by providing participatory opportunities to promote PA behaviour change. Outcomes will be measured at baseline (T1), immediately postintervention at 8 weeks (T2) and at 26 weeks postbaseline (T3). The primary outcomes are the Canadian Occupational Performance Measure for both child and parent participation goals and child physical performance goal. Secondary outcomes include daily time spent in moderate to vigorous PA and sedentary time, gross motor function, quality of life, barriers to participation for the children and parents' PA and sedentary time. Intervention acceptability and experiences of PA participation will be explored using a qualitative descriptive approach. Background: The Children's Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC/23/QCHQ/100850) and The University of Queensland Human Research Ethics Committee (2024/HE000054) have approved this study. The results of the study will be disseminated to families and community agencies as guided by our advisory group and as conference abstracts and presentations, peer-reviewed articles in scientific journals and institution newsletters and media releases. Background: ACTRN12624000042549, Universal Trial Number: U1111-1300-7421; Australian New Zealand Clinical Trials Registry.
Study protocol for the Australasian Cerebral Palsy Musculoskeletal Health Network (AusCP MSK) prospective cohort study: early detection of musculoskeletal complications in young children with moderate to severe cerebral palsy (GMFCS III-V).BMJ Open • April 30, 2025
Craig Munns, Laura Bentley, Roslyn Boyd, Denise Brookes, Maddison Taylor, Peter Pivonka, Natasha Nassar, Stewart Trost, J Little, Kylie Tucker, Joshua Burns, Leanne Sakzewski, Nadia Badawi, Robert Ware, Tracy Comans, Kate Willoughby, Simon Paget
Background: Cerebral palsy (CP) is the most common physical disability of childhood, affecting movement and posture, resulting from a neurological insult during pregnancy or the neonatal period. While the brain lesion is static, the musculoskeletal sequelae in CP are often progressive and lifelong, associated with pain and can impact the lives of children with CP, their families and the healthcare system. The Australasian Cerebral Palsy Musculoskeletal Health Network (AusCP MSK) study will conduct comprehensive, population-based surveillance of children with moderate to severe functional mobility limitations (Gross Motor Function Classification System (GMFCS) levels III-V) to explore the early biomarkers of, and interactions between, musculoskeletal complications related to CP, including hip displacement, scoliosis and skeletal fragility.
Methods: The AusCP MSK study involves three cohorts of children. Cohort A (n=500) is a multicentre retrospective (3 years) and prospective (4 years) cohort study in children aged 4-9 years that will be implemented at five sites across Australia and New Zealand. Retrospective data will include clinical history, information on CP diagnosis and other investigations (previous X-rays and biochemistry). Primary prospective outcomes will involve measures of hip displacement (migration percentage, acetabular index, femoral head orientation, Hilgenreiner's epiphyseal angle), scoliosis (Anteroposterior/Posteroanterior and lateral spine X-ray), skeletal fragility (Dual Energy X-ray Absorptiometry, peripheral quantitative computed tomography), motor function (GMFCS, Manual Ability Classification System (MACS) and Communication Function Classification System (CFCS)) and range of movement (lower limb and spine). Cohort B (n=4000) is a retrospective analysis of data to evaluate fractures in children up to 18 years of age with CP (GMFCS I-V) from the New South Wales (NSW)/Australian Capital Territory CP Registers linked with corresponding records from NSW administrative health data (n=3000), and a New Zealand cohort of linked data from the New Zealand Cerebral Palsy Register to the Accident Compensation Corporation data for fracture claims (n=1000). Cohort C (n=30) will cross-sectionally examine bone quality through a transiliac bone biopsy in children undergoing scheduled hip surgery. Relationships between early biomarkers, early brain structure and musculoskeletal complications will be explored using multilevel mixed-effect models. Background: Ethical approval for this study was granted by Children's Health Queensland Hospital and Health Service Human Research Ethics Committee, The University of Queensland Human Research Ethics Committee and the New Zealand Health and Disability Ethics Committee.Research outcomes will be disseminated via scientific conferences and publications in peer-reviewed journals; to the National Bodies and Clinicians; and to people with CP and their families. Background: Australian New Zealand Clinical Trials Registry number: ACTRN12622000788774p.
A Multisite Randomized Controlled Trial of Hand Arm Bimanual Intensive Training Including Lower Extremity for Children with Bilateral Cerebral Palsy.The Journal Of Pediatrics • January 23, 2025
Leanne Sakzewski, Yannick Bleyenheuft, Iona Novak, Catherine Elliott, Sarah Reedman, Catherine Morgan, Kerstin Pannek, Natalie Santos, Ashleigh Hines, Sherilyn Nolan, Robert Ware, Roslyn Boyd
Objective: To test the efficacy of Hand Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT-ILE) to improve gross motor function, manual ability, goal performance, walking endurance, mobility, and self-care for children with bilateral cerebral palsy. Methods: This prospective, waitlist randomized controlled trial included children with bilateral cerebral palsy, aged 6-to-16-years and classified Gross Motor Function Classification System levels II to IV. HABIT-ILE delivered for 2 weeks (65 hours) was compared with usual care. Primary outcomes postintervention were gross motor function (Gross Motor Function Measure-66) and manual ability (ABILHAND-Kids). Secondary outcomes were goal performance (Canadian Occupational Performance Measure), self-care and mobility (Pediatric Evaluation of Disability Inventory-Computer Adapted Test), bimanual hand performance (Both Hands Assessment), and walking endurance (6 Minute Walk Test). Linear regression models were used to determine between group differences, adjusted for baseline scores. Results: Ninety-two children were recruited; 2 were deemed ineligible after randomization and were excluded. Ninety children (HABIT-ILE n = 46, usual care n = 44), mean age 10.4 (SD 3.0) years, Gross Motor Function Classification System II = 32; III = 31; IV = 27 were included. HABIT-ILE led to superior gains in manual ability (mean difference 0.85, 95% CI 0.38-1.33; P < .001) but not gross motor function. HABIT-ILE led to superior changes on goal performance, self-care, and mobility. Conclusions: HABIT-ILE was effective in improving manual ability, mobility, self-care, and goal performance, but not gross motor function. Significant gains were immediately retained at 26 weeks postintervention. Large individual variability suggests further analyses need to be performed to understand characteristics of children who achieved clinically meaningful gains across outcomes.
