NCT06916988 Modified and Context-Focused Sports Intervention in Adolescents With Autism: Study Protocol
| NCT ID | NCT06916988 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Federal University of Minas Gerais |
| Condition | Autism Spectrum Disorder (ASD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 52 participants in total. It began in 2025-06-01 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Hércules R Leite, Doctor
STUDY DIRECTOR
Federal University of Minas Gerais
Frequently Asked Questions
Who can join the NCT06916988 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 18 Years, studying Autism Spectrum Disorder (ASD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06916988 currently recruiting?
Yes, NCT06916988 is actively recruiting participants. Contact the research team at lidiborges.fisio@gmail.com for enrollment information.
Where is the NCT06916988 trial being conducted?
This trial is being conducted at Belo Horizonte, Brazil.
Who is sponsoring the NCT06916988 clinical trial?
NCT06916988 is sponsored by Federal University of Minas Gerais. The principal investigator is Hércules R Leite, Doctor at Federal University of Minas Gerais. The trial plans to enroll 52 participants.