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Clinical Trials/NCT06916988
NCT06916988RecruitingNot Applicable

Modified Sports Intervention Combined With Context-Focused Intervention in Adolescents With Autism Spectrum Disorder: Protocol for a Mixed Methods Study

Federal University of Minas Gerais1 site in 1 country52 target enrollmentStarted: June 1, 2025Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
52
Locations
1
Primary Endpoint
Physical Literacy Profile Questionnaire

Study Overview

Brief Summary

Adolescents with Autism Spectrum Disorder (ASD) typically engage less in physical activities than their typically developing peers, influenced by intrinsic and extrinsic factors. Modified sports interventions, like Sports Stars Brazil, can improve motor skills and promote lifelong participation in sports by enhancing physical, social, and cognitive abilities. However, adolescents often face barriers to engaging in community sports and recreational activities after completing the program. PREP is an approach designed to address these barriers by modifying environments and empowering families. To date, no study has explored this combination in adolescents with ASD. Objective: This protocol assesses the effectiveness of combining Sports Stars Brazil with PREP to enhance participation and physical literacy in adolescents with ASD and explores participant and family perceptions. Method: A mixed-methods study with two phases: 1) a randomized controlled trial to investigate combined intervention's effects; and 2) evaluation of participant and family perceptions.

Detailed Description

Adolescents exhibit higher levels of sedentary behavior compared to other age groups. This situation is even more evident among adolescents with Autism Spectrum Disorder (ASD), who show significantly lower levels of physical activity than typically developing adolescents. Studies have revealed that most adolescents with ASD did not meet the three components of the Canadian 24-Hour Movement Guidelines, which include physical activity, sedentary time, and sleep. Low levels of physical activity may contribute to high rates of physical or mental health problems among young people with ASD, including a higher prevalence of overweight and obesity.

Intrinsic factors, such as mobility limitations and difficulties with social interaction, may restrict the participation of children and adolescents with ASD in physical activities. Despite these challenges, evidence suggests that including these young people in physical activity programs can yield significant benefits, such as increased peer social interaction and improvements in motor and communication skills. However, participation in physical activities tends to decline with age, resulting in less engagement from adolescents with ASD compared to younger children with the same diagnosis. Therefore, it is crucial to develop effective strategies to promote the participation of these individuals in physical activities.

Several interventions aim to promote the participation of children and adolescents with ASD in physical activities, including modified sports programs. These programs are defined as recreational activities where rules, equipment, or spaces are modified to enhance sports inclusion and develop fundamental motor skills. Despite the recognition of the importance of modified sports for children's preparation for sports and physical activity, there is still a lack of such interventions for individuals with disabilities, especially in low- and middle-income countries. To address this gap, the Sports Stars program was developed in Australia. This intervention involves modified sports activities led by professionals and delivered in peer groups. Sports Stars focuses on supporting the development of intrinsic factors, such as physical, social, cognitive, and psychological competence in children, or their physical literacy. The program was adapted to the Brazilian context to promote the participation of children and adolescents with cerebral palsy and ASD in physical activities.

A quasi-experimental study assessed the acceptability and initial outcomes of this modified sports intervention for Brazilian adolescents with ASD. Sports Stars proved to be feasible, and the preliminary results were positive for promoting participation and improving gross motor skills (such as locomotion and object control), physical conditioning, and physical literacy (social, psychological, cognitive, and physical) in these individuals. However, no planned clinical trials have yet been conducted specifically for this population. Although adolescents improved their participation in the Sports Stars program, these individuals and their families still report barriers to participation in sports and community recreational activities.

Modified sports interventions promote participation in physical activities in individuals with ASD by addressing intrinsic factors; however, they do not address contextual barriers, such as environmental and interpersonal factors, which also influence participation. Factors such as bullying, parents' perceptions often prioritizing therapeutic intervention, and challenges faced in community programs (such as the lack of adaptations in existing programs to meet their needs) are still prevalent.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

Assessors will remain blinded to group allocation. However, due to the nature of the intervention in this study, it will not be possible to ensure blinding for the individuals and intervention therapists.

Eligibility Criteria

Ages
12 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of Autism Spectrum Disorder (ASD).
  • Level I of functioning (able to maintain interaction and adapt to changes).
  • Level II of functioning (able to communicate with others but faces difficulties when changes occur) according to the Autism Spectrum Disorder Social Communication Functioning Classification System.

Exclusion Criteria

  • Cognitive limitations
  • Behavioral limitations
  • Clinical limitations (e.g., severe cardiorespiratory disease)

Arms & Interventions

Modified sports

Placebo Comparator

Control group:

Modified sports. 26 adolescents performed only the modified sports protocol

Intervention: Sports Stars Brazil (Behavioral)

Modified sports + context-centered therapy

Experimental

Intervention group:

Modified sports + context-centered therapy. 26 adolescents performed the modified sports protocol associated with context-centered therapy.

Intervention: Sports Stars Brazil (Behavioral)

Modified sports + context-centered therapy

Experimental

Intervention group:

Modified sports + context-centered therapy. 26 adolescents performed the modified sports protocol associated with context-centered therapy.

Intervention: context-centered therapy (Behavioral)

Outcomes

Primary Outcomes

Physical Literacy Profile Questionnaire

Time Frame: From registration to end of treatment in 10 weeks

As an outcome measure, the Physical Literacy Profile Questionnaire will be used, currently being validated by our research group. Developed in Portuguese, this instrument assesses the level of Physical Literacy in children, adolescents, and adults (ages 6-21), focusing on the individual's perception of their participation in the Sports Stars (SS) program. The questionnaire consists of two parts: the first, with 5 questions, evaluates the participant's perception of their experience in the modified sports program; the second, composed of 24 multiple-choice items, examines the individual's performance in physical, social, and cognitive skills. Each item is rated on a scale of 0 to 2 (0: does not perform, 1: performs partially, 2: fully performs). Higher scores (closer to 2) indicate better physical literacy and greater engagement, while lower scores (closer to 0) suggest poorer outcomes.

Goal Attainment Scale

Time Frame: From registration to end of treatment in 10 weeks

Goal Attainment Scale : A scale used to assess and quantify the achievement of goals previously established in collaboration with the patient/family. This allows for the evaluation of goal attainment and comparison of the interventions used in the process. The scores range from (+2) for the best outcomes to (-2) for the worst, in accordance with the expected results. It is recommended to set at least two goals and a maximum of four to be achieved within the same period. Higher scores (closer to +2) represent better outcomes, indicating that the goal was successfully achieved or even exceeded. Conversely, lower scores (closer to -2) indicate worse outcomes, suggesting that the goal was not achieved as planned.

Canadian Occupational Performance Measure

Time Frame: From registration to end of treatment in 10 weeks

Canadian Occupational Performance Measure: A widely used assessment tool designed to measure a person's perceived performance and satisfaction with their daily activities (occupations). It allows individuals to identify and prioritize the areas in which they want to see improvement. The COPM uses a 10-point scale for both performance and satisfaction, with scores ranging from 1 to 10. A score of 1 indicates "not able to perform" or "extremely dissatisfied," while a score of 10 indicates "able to perform at the desired level" or "extremely satisfied." Higher scores indicate better outcomes, meaning greater satisfaction and higher perceived performance in the selected activities.

Family Empowerment Scale

Time Frame: From registration to end of treatment in 10 weeks

The Family Empowerment Scale is an assessment tool used to measure the empowerment of families with children who have disabilities. It evaluates how well families feel they can influence decisions regarding their child's care and the services they receive. The scale focuses on key areas such as family support, decision-making, and advocacy. The FES uses a 5-point Likert scale, with scores ranging from 1 to 5. A score of 1 indicates strong disagreement or low empowerment, while a score of 5 indicates strong agreement or high empowerment. Higher scores represent better outcomes, indicating greater family empowerment, with families feeling more confident and capable in managing their child's needs and advocating for services.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Federal University of Minas Gerais
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lidiane Francisca Borges Ferreira

Master in Occupational Studies

Federal University of Minas Gerais

Study Sites (1)

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