NCT06916988

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Jun 2025Jun 2027

First Submitted

Initial submission to the registry

March 26, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 8, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

March 26, 2025

Last Update Submit

March 12, 2026

Conditions

Keywords

Context-centered interventionParticipationAdolescentsModified SportsAutism Spectrum Disorder

Outcome Measures

Primary Outcomes (4)

  • Physical Literacy Profile Questionnaire

    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.

    From registration to end of treatment in 10 weeks

  • Goal Attainment Scale

    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.

    From registration to end of treatment in 10 weeks

  • Canadian Occupational Performance Measure

    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.

    From registration to end of treatment in 10 weeks

  • Family Empowerment Scale

    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.

    From registration to end of treatment in 10 weeks

Study Arms (2)

Modified sports

PLACEBO COMPARATOR

Control group: Modified sports. 26 adolescents performed only the modified sports protocol

Behavioral: Sports Stars Brazil

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.

Behavioral: Sports Stars BrazilBehavioral: context-centered therapy

Interventions

Modified sports interventions promote physical activity participation 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 like bullying, parents' perceptions often prioritizing therapy intervention, and challenges faced in community programs (as the lack of adaptations in existing programs to meet their needs) are some of these obstacles, which reduce adherence to physical activities (Jachyra et al., 2021). Therefore, it may be necessary to combine interventions targeting intrinsic factors, such as Sports Stars, with those that address the extrinsic contextual factors impacting the participation of adolescents with ASD in their community.

Modified sportsModified sports + context-centered therapy

The complimentary approach of combining intrinsic (Sports Stars) and extrinsic (PREP) interventions aligns with the relationships between the person, their environment, and the quantity and quality of their participation proposed in the "family of participation related constructs (Imms et al., 2017)." By recognizing that participation depends on both the individual's abilities and the contexts and conditions in which it occurs, professionals can adopt a more holistic and tailored approach to individual needs (Imms et al., 2015).

Modified sports + context-centered therapy

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 31270-901, Brazil

RECRUITING

Related Publications (1)

  • Fernandes AC, Souto DO, de Sousa Junior RR, Clutterbuck GL, Wright FV, de Souza MG, Ferreira LFB, Cardoso Rodrigues AA, Camargos ACR, Leite HR. Sports Stars Brazil in children with autism spectrum disorder: A feasibility randomized controlled trial protocol. PLoS One. 2023 Nov 8;18(11):e0291488. doi: 10.1371/journal.pone.0291488. eCollection 2023.

    PMID: 37939077BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Hércules R Leite, Doctor

    Federal University of Minas Gerais

    STUDY DIRECTOR

Central Study Contacts

LIDIANE F BORGES, Master

CONTACT

Hércules R Leite, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Adolescents (n=52) will be randomized into two groups in Phase 1: Sports Stars Brazil (n=26) and Sports Stars Brazil + PREP (n=26). Randomization will occur in blocks, with each randomization taking place once two subgroups of 6-8 participants are recruited. A random number generator will be used to create a random sequence of numbers. These numbers will be concealed in individually numbered, opaque, sealed envelopes. This sequence will determine whether participants are assigned to the Sports Stars Brazil group or the control group. A new random sequence will be used for each subgroup randomization until all 52 adolescents are allocated or no additional participants can be recruited. 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master in Occupational Studies

Study Record Dates

First Submitted

March 26, 2025

First Posted

April 8, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Sharing of individual participant data will not be carried out due to privacy and confidentiality concerns.

Locations