Sports Stars Brazil in children with autism spectrum disorder: A feasibility randomized controlled trial protocol.

BACKGROUND

Autism Spectrum Disorder (ASD) children have lower levels of participation in recreational and sporting activities when compared to their peers. Participation has been defined based on the Family of Participation-Related Constructs (fPRC) which defines participation as including both attendance and involvement, with sense of self, preferences and activity competence related to a child's participation. Modified sports interventions such as Sports Stars can act on physical literacy and some of the fPRCs components. This study aims to assess the feasibility of the Sports Stars Brazil intervention for children with ASD.

METHODS

This study will be conducted with 36 participants with ASD aged 6 to 12 years old following the CONSORT for pilot and feasibility recommendation. Participants will be randomly allocated into two groups. Intervention group will receive eight, weekly Sports Stars sessions. Each session will include of sports-focused gross motor activity training, confidence building, sports-education and teamwork development. Study assessments will occur at baseline, immediately post-intervention and 20-weeks post-randomization. First, we will assess process feasibility measures: recruitment, assessment completion, adherence, adverse events and satisfaction. Second, we will investigate the scientific feasibility of the intervention by estimating the effect size and variance at the level of achievement sports-related activity and physical activity participation goals (Goal Attainment Scaling), activity competence (Ignite Challenge, Test of Gross Motor Development-second edition, Physical Literacy Profile Questionnaire, Pediatric Disability Assessment Inventory-Computer Adaptive Test-PEDI-CAT-mobility, 10×5 Sprint Test and Muscle Power Sprint Test), sense of self (PEDI-CAT-responsibility), and overall participation at home, school and community, (Participation and Environment Measure for children and young people, PEM-CY).

DISCUSSION

The results of this feasibility study will inform which components are critical to planning and preparing a future RCT study, aiming to ensure that the RCT will be feasible, rigorous and justifiable.

TRIAL REGISTRATION

The trial was registered with the Brazilian Registry of Clinical Trials database (ID: RBR-9d5kyq4) on June 15, 2022.