Autism Spectrum DisorderEarly Phase 1NCT07432776
Effect of an 8-Week Pickleball Program for Adults With Autism: A Feasibility Trial With a Delayed-Control Design
A Early Phase 1 study testing Pickleball Program (Community-Based) in people with Autism Spectrum Disorder, run by Penn State University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if an 8-week, community-based pickleball program can improve sensory-motor function and reduce the severity of core autism symptoms in adults ages 18-45 with autism spectrum disorder (ASD) who can participate independently without a caregiver. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Pickleball Program (Community-Based)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2026to 15 Jul 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-45 years
- Clinical diagnosis of autism spectrum disorder (ASD)
- Able to participate in group-based activities without caregiver support
- Able to understand English and independently communicate without assistance
- Available for at least two sessions per week for the intervention dates
- Access to reliable transportation to the intervention site
- Able to provide informed consent (i.e., no legally authorized representative)
- Pre-exercise screening indicates medical clearance is not needed, based on ACSM guidelines
Who cannot join
- Clinical diagnosis of intellectual disability (ID)
- Does not have normal or corrected-to-normal vision
- Actively participating in a racquet sport ≥1 time per week
- Use of mobility aids
- Moderate-to-severe joint pain (WOMAC pain subscale)
- Neurologic conditions (cerebral palsy, severe head injury, progressive neurological disorders, epilepsy)
- Individuals who cannot provide their own informed consent (i.e., have a legally authorized representative)
- Individuals who require medical clearance for exercise based on the ACSM preparticipation screening questionnaire
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Penn State Harrisburg
Middletown, Pennsylvania, 17011
Daniel E Lidstone, Ph.D., 828-719-7002, dbl5689@psu.edu
About this study
Official title: Effects of an 8-Week Pickleball Intervention on Sensorimotor Function, Sleep, Depressive Symptoms, and Core Autism Features in Adults With Autism Spectrum Disorder: A Feasibility Trial With a Delayed-Control Design
The goal of this clinical trial is to learn if an 8-week, community-based pickleball program can improve sensory-motor function and reduce the severity of core autism symptoms in adults ages 18-45 with autism spectrum disorder (ASD) who can participate independently without a caregiver.
The main questions it aims to answer are:
Read more
- Does participating in the pickleball program improve sensory-motor function (including visual-motor integration and proprioceptive bias), measured using the HaptiKart task and a pickleball skill assessment?
- Does participating in the pickleball program reduce core autism symptom severity, measured by the Social Responsiveness Scale, 2nd edition (SRS-2)?
Researchers will compare an early-start pickleball group to a delayed-start control group (who continues usual activities at first) to see if the pickleball program leads to greater improvements in sensory-motor outcomes and ASD symptom severity.
Participants will:
- Complete an in-person baseline visit at a local public library to provide written consent, complete surveys (SRS-2, PROMIS Depression and Sleep measures, and WHOQOL-BREF), and complete a video game-based sensory-motor assessment (HaptiKart).
- Be randomly assigned to either start pickleball classes immediately or after an initial delay period.
- Attend pickleball classes twice per week for 8 weeks (90 minutes per class; 16 sessions total), led by trained instructors at community indoor court facilities.
- Continue their usual activities during periods when they are not assigned to pickleball classes.
- Complete a brief pickleball skill assessment during the intervention period at their first and last class.
- Complete follow-up assessments after each phase of the study to repeat surveys and sensory-motor testing.
- Participants will also wear a small activity monitor (ActiGraph) during pickleball sessions to measure in-class physical activity levels, and complete brief online check-ins about safety/injury and program feedback during the intervention period.
Read the detailed description
Autism spectrum disorder (ASD) is associated with sensory-motor impairments that can impact everyday functioning. Prior research suggests that disrupted visual-motor integration and altered sensory weighting (e.g., greater reliance on proprioceptive input relative to visual input) may relate to the severity of core autism symptoms. The current study evaluates whether a structured, community-based pickleball program can serve as a practical and scalable behavioral intervention to modify these sensory-motor mechanisms and improve outcomes in autistic adults.
Study Design
This study is a two-arm, parallel-group, delayed controlled trial (DCT) evaluating the effects of an 8-week pickleball intervention delivered in a community setting. Participants complete baseline testing and are randomized 1:1 to either:
- Early Start Group: completes pickleball classes during Phase 1
- Delayed Start Group: continues usual activity during Phase 1 and completes pickleball during Phase 2
Phase 1 is structured as the randomized comparison period. All participants complete post-testing at the end of Phase 1. The delayed group then receives the intervention during Phase 2. This design allows both a controlled between-group comparison during Phase 1 and a within-subject evaluation of change across all participants once they receive the intervention.
The study is planned to occur between February and May 2026, with assessments occurring at defined pre- and post-intervention timepoints.
Intervention Overview (Pickleball Program) The intervention consists of twice-weekly pickleball sessions for 8 weeks (16 sessions total). Each session lasts approximately 90 minutes and is delivered at indoor community court facilities with trained instructors. At least one study team member is present, along with undergraduate research assistants, to support implementation and monitoring.
Each session follows a standardized structure:
- Welcome/introduction
- Dynamic warm-up
- Skill-focused drills
- Supervised gameplay
- Cooldown with stretching
The class is designed to be beginner-friendly and self-paced, with built-in opportunities for rest and hydration. Participants may stop or rest as needed.
Testing Visits and Assessments Participants complete a structured series of assessments at baseline and follow-up timepoints. Data collection includes physical measurements, survey measures, and behavioral/motor testing. Testing procedures occur in-person at community-based testing locations selected to reduce access barriers. Written informed consent is obtained at the testing visit before any study procedures occur.
Sensory-Motor Function Assessment (Primary Outcome Domain)
Sensory-motor outcomes are assessed using two primary approaches:
- HaptiKart Task Participants complete HaptiKart, a computerized steering task designed to quantify proprioceptive versus visual feedback bias. The task uses a force-feedback steering wheel and includes brief delays in visual or proprioceptive feedback to assess sensory integration during dynamic control. The task includes familiarization and test blocks and generates quantitative metrics of sensory-motor bias and task performance.
- Pickleball Skill Assessment Pickleball skill is assessed using a structured ball-return task. An instructor feeds a standardized total of 40 balls under multiple conditions corresponding to different court locations and shot types. Trials are scored based on contact quality and accuracy using a standardized scoring approach, producing location-specific totals and an overall performance estimate. Video and audio recordings are collected to support quantitative and qualitative evaluation of paddle stroke mechanics and performance outcomes.
Autism Symptom Severity (Primary Outcome Domain) Core ASD symptom severity is assessed using the Social Responsiveness Scale, 2nd edition (SRS-2), adult self-report form. The primary symptom endpoint is the SRS-2 total score.
Secondary Outcomes
Secondary outcomes include self-reported measures of mental health and quality of life:
- PROMIS Depression subscale
- PROMIS Sleep measures (sleep disturbance and sleep-related impairment)
- WHOQOL-BREF quality of life measure
Physical Activity Monitoring (In-Session) To characterize activity levels during the intervention, wearable actigraphy (ActiGraph) is used to monitor movement intensity during pickleball classes on a bimonthly basis. The device is worn around the waist during class sessions and passively records movement without collecting audio, video, or location information.
Safety and Acceptability Monitoring Participants currently receiving the pickleball intervention complete brief bimonthly online check-ins (via REDCap) to monitor pain/injury and provide structured qualitative feedback.
Study Groups and Assessment Schedule
The delayed-control structure results in different assessment schedules depending on group assignment:
- Both randomized groups complete baseline testing and an immediate post-Phase 1 assessment.
- The delayed group completes a final post-intervention assessment after completing Phase 2.
- The early group completes an additional follow-up assessment after Phase 2 to examine whether changes persist after intervention completion.
In addition, the protocol allows continued enrollment during Phase 1 so that "late enrolled" participants can complete Phase 2 intervention participation and contribute to within-subject pre/post analyses, though not to the randomized Phase 1 comparison.
Sample Size and Accrual The study plans to enroll up to 50 participants to account for screen failures and attrition, with an expected completed sample of approximately 30-35 participants.
Planned Analytic Approach The study is designed to estimate the potential effectiveness of the pickleball program by comparing pre-to-post changes in primary and secondary outcomes. The Phase 1 randomized component supports a between-group comparison of change scores during the controlled period, while the delayed-start design also supports within-subject change analyses across participants who complete the intervention.
Study Setting Testing is conducted in community-based locations near the intervention sites to reduce participation barriers. Pickleball sessions are conducted at indoor community recreation facilities.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Pickleball Program (Community-Based)
- Keywords
- Autism Spectrum Disorder, ASD, Autism, Adult, Pickleball, Sensory-Motor, Sensorimotor
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pickleball Program (Community-Based)Behavioural
Group-based beginner-friendly pickleball classes delivered in community indoor court facilities. Sessions occur twice per week for 8 weeks (16 sessions total), approximately 90 minutes per session, led by trained instructors.
| Study group | Role | What they receive |
|---|---|---|
| Early Start Pickleball (Intervention) | Experimental | Participants assigned to this arm begin the community-based pickleball program immediately after baseline testing. They participate in supervised pickleball classes twice per week for 8 weeks (16 sessions total). Assessments are completed at baseline and after the Phase 1 intervention period. Participants then return to usual activities during Phase 2 and complete a follow-up assessment. Receives: Behavioral: Pickleball Program (Community-Based) |
| Delayed Start (Waitlist/Usual Activity Control) | Other | Participants assigned to this arm continue their usual activities during Phase 1 (no pickleball classes during this initial period). They complete baseline and post-Phase 1 assessments, then begin the same community-based pickleball program during Phase 2 (twice per week for 8 weeks; 16 sessions total). A final post-intervention assessment is completed after the Phase 2 intervention period. Receives: Behavioral: Pickleball Program (Community-Based) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory-Motor Function (HaptiKart task outcomes)
Sensory-motor integration and proprioceptive bias measured using the HaptiKart videogame task.
Measured: T1 (Week 0, enrollment) may occur up to 4 weeks prior to initiation of pickleball intervention; T2 approximately 10 weeks after baseline (up to 12 weeks); T3 approximately 18 weeks after baseline (up to 20 weeks).
Autism Symptom Severity (SRS-2 Total Score)
Core autism symptom severity measured by the Social Responsiveness Scale, 2nd edition (SRS-2), adult self-report, total score. The SRS-2 consists of 65 items rated on a 4-point Likert scale (1 = not true; 4 = almost always true). Raw total scores range from 0 to 195. Higher scores indicate greater severity of autism-related social impairment.
Measured: T1 (Week 0, enrollment) may occur up to 4 weeks prior to initiation of pickleball intervention; T2 approximately 10 weeks after baseline (up to 12 weeks); T3 approximately 18 weeks after baseline (up to 20 weeks).
Secondary outcomes (4)
Depression Symptoms (PROMIS Depression)
Self-reported depressive symptoms measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression-Short Form. (8-item version). Items are rated on a 5-point Likert scale (1 = never to 5 = always). Raw summed scores range from 8 to 40. Raw scores are converted to standardized PROMIS T-scores (mean = 50, standard deviation = 10) using established scoring tables. Higher T-scores indicate greater depressive symptom severity. T-scores will be used for primary analyses.
Measured: T1 (Week 0, enrollment) may occur up to 4 weeks prior to initiation of pickleball intervention; T2 approximately 10 weeks after baseline (up to 12 weeks); T3 approximately 18 weeks after baseline (up to 20 weeks).
Sleep-Related Impairment
Self-reported sleep disturbance and sleep-related impairment measured using Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment - Short Form 8a. The instrument includes 8 items rated on a 5-point Likert scale. Raw summed scores range from 8 to 40. Raw scores are converted to standardized PROMIS T-scores (mean = 50, standard deviation = 10) using published scoring tables. Higher T-scores indicate greater sleep-related impairment (worse daytime functioning related to poor sleep). T-scores will be used for primary analyses.
Measured: T1 (Week 0, enrollment) may occur up to 4 weeks prior to initiation of pickleball intervention; T2 approximately 10 weeks after baseline (up to 12 weeks); T3 approximately 18 weeks after baseline (up to 20 weeks).
Sleep Disturbance
Sleep disturbance will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance-Short Form 8b. The instrument includes 8 items rated on a 5-point Likert scale. Raw summed scores range from 8 to 40. Raw scores are converted to standardized PROMIS T-scores (mean = 50, standard deviation = 10) using published scoring tables. Higher T-scores indicate greater sleep disturbance (worse perceived sleep quality). T-scores will be used for primary analyses.
Measured: T1 (Week 0, enrollment) may occur up to 4 weeks prior to initiation of pickleball intervention; T2 approximately 10 weeks after baseline (up to 12 weeks); T3 approximately 18 weeks after baseline (up to 20 weeks).
Quality of Life (WHOQOL-BREF)
Quality of life will be measured using the World Health Organization Quality of Life-BREF (WHOQOL-BREF). The WHOQOL-BREF contains 26 items rated on a 5-point Likert scale and yields four domain scores: Physical Health, Psychological Health, Social Relationships, and Environment. Raw domain scores are transformed to a 0-100 scale according to WHO scoring guidelines. Higher scores indicate better quality of life. Domain scores will be analyzed as continuous outcomes.
Measured: T1 (Week 0, enrollment) may occur up to 4 weeks prior to initiation of pickleball intervention; T2 approximately 10 weeks after baseline (up to 12 weeks); T3 approximately 18 weeks after baseline (up to 20 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start2 Feb 2026
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a two-arm, parallel-group, delayed-start controlled trial design. Participants are randomized in a 1:1 ratio to either an Early Start intervention group or a Delayed Start group. Randomization is performed separately within each location to maintain balanced group allocation at each site. During Phase 1, the Early Start group participates in the 8-week pickleball intervention while the Delayed Start group continues usual activities. After completion of Phase 1 assessments, the Delayed Start group receives the same intervention during Phase 2. The Early Start group resumes usual activities during Phase 2 and completes an additional follow-up assessment to evaluate whether intervention-related changes are maintained beyond the initial intervention period.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Lidstone, Penn State University
- Investigators
- Chris Sciammana, MD, Principal investigator, Penn State College of MedicineDaniel E Lidstone, Ph.D., Principal investigator, Penn State Harrisburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432776
- Sponsor's protocol ID
- STUDY00027574
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lidstone DE, Singhala M, Wang LJ, Brown JD, Mostofsky SH. HaptiKart: An engaging videogame reveals elevated proprioceptive bias in individuals with autism spectrum disorder. PLOS Digit Health. 2025 Jun 18;4(6):e0000879. doi: 10.1371/journal.pdig.0000879. eCollection 2025 Jun.
PubMed 40531815
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an 8-Week Pickleball Intervention on Sensorimotor Function, Sleep, Depressive Symptoms, and Core Autism Features in Adults With Autism Spectrum Disorder: A Feasibility Trial With a Delayed-Control Design
- ClinicalTrials.gov ID
- NCT07432776
- Acronym / sponsor ID
- STUDY00027574
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, ASD, Autism, Adult, Pickleball, Sensory-Motor, Sensorimotor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if an 8-week, community-based pickleball program can improve sensory-motor function and reduce the severity of core autism symptoms in adults ages 18-45 with autism spectrum disorder (ASD) who can participate independently without a caregiver.
The main questions it aims to answer are:
- Does participating in the pickleball program improve sensory-motor function (including visual-motor integration and proprioceptive bias), measured using the HaptiKart task and a pickleball skill assessment?
- Does participating in the pickleball program reduce core autism symptom severity, measured by the Social Responsiveness Scale, 2nd edition (SRS-2)?
Researchers will compare an early-start pickleball group to a delayed-start control group (who continues usual activities at first) to see if the pickleball program leads to greater improvements in sensory-motor outcomes and ASD symptom severity.
Participants will:
- Complete an in-person baseline visit at a local public library to provide written consent, complete surveys (SRS-2, PROMIS Depression and Sleep measures, and WHOQOL-BREF), and complete a video game-based sensory-motor assessment (HaptiKart).
- Be randomly assigned to either start pickleball classes immediately or after an initial delay period.
- Attend pickleball classes twice per week for 8 weeks (90 minutes per class; 16 sessions total), led by trained instructors at community indoor court facilities.
- Continue their usual activities during periods when they are not assigned to pickleball classes.
- Complete a brief pickleball skill assessment during the intervention period at their first and last class.
- Complete follow-up assessments after each phase of the study to repeat surveys and sensory-motor testing.
- Participants will also wear a small activity monitor (ActiGraph) during pickleball sessions to measure in-class physical activity levels, and complete brief online check-ins about safety/injury and program feedback during the intervention period.
Detailed description
Autism spectrum disorder (ASD) is associated with sensory-motor impairments that can impact everyday functioning. Prior research suggests that disrupted visual-motor integration and altered sensory weighting (e.g., greater reliance on proprioceptive input relative to visual input) may relate to the severity of core autism symptoms. The current study evaluates whether a structured, community-based pickleball program can serve as a practical and scalable behavioral intervention to modify these sensory-motor mechanisms and improve outcomes in autistic adults.
Study Design
This study is a two-arm, parallel-group, delayed controlled trial (DCT) evaluating the effects of an 8-week pickleball intervention delivered in a community setting. Participants complete baseline testing and are randomized 1:1 to either:
- Early Start Group: completes pickleball classes during Phase 1
- Delayed Start Group: continues usual activity during Phase 1 and completes pickleball during Phase 2
Phase 1 is structured as the randomized comparison period. All participants complete post-testing at the end of Phase 1. The delayed group then receives the intervention during Phase 2. This design allows both a controlled between-group comparison during Phase 1 and a within-subject evaluation of change across all participants once they receive the intervention.
The study is planned to occur between February and May 2026, with assessments occurring at defined pre- and post-intervention timepoints.
Intervention Overview (Pickleball Program) The intervention consists of twice-weekly pickleball sessions for 8 weeks (16 sessions total). Each session lasts approximately 90 minutes and is delivered at indoor community court facilities with trained instructors. At least one study team member is present, along with undergraduate research assistants, to support implementation and monitoring.
Each session follows a standardized structure:
- Welcome/introduction
- Dynamic warm-up
- Skill-focused drills
- Supervised gameplay
- Cooldown with stretching
The class is designed to be beginner-friendly and self-paced, with built-in opportunities for rest and hydration. Participants may stop or rest as needed.
Testing Visits and Assessments Participants complete a structured series of assessments at baseline and follow-up timepoints. Data collection includes physical measurements, survey measures, and behavioral/motor testing. Testing procedures occur in-person at community-based testing locations selected to reduce access barriers. Written informed consent is obtained at the testing visit before any study procedures occur.
Sensory-Motor Function Assessment (Primary Outcome Domain)
Sensory-motor outcomes are assessed using two primary approaches:
- HaptiKart Task Participants complete HaptiKart, a computerized steering task designed to quantify proprioceptive versus visual feedback bias. The task uses a force-feedback steering wheel and includes brief delays in visual or proprioceptive feedback to assess sensory integration during dynamic control. The task includes familiarization and test blocks and generates quantitative metrics of sensory-motor bias and task performance.
- Pickleball Skill Assessment Pickleball skill is assessed using a structured ball-return task. An instructor feeds a standardized total of 40 balls under multiple conditions corresponding to different court locations and shot types. Trials are scored based on contact quality and accuracy using a standardized scoring approach, producing location-specific totals and an overall performance estimate. Video and audio recordings are collected to support quantitative and qualitative evaluation of paddle stroke mechanics and performance outcomes.
Autism Symptom Severity (Primary Outcome Domain) Core ASD symptom severity is assessed using the Social Responsiveness Scale, 2nd edition (SRS-2), adult self-report form. The primary symptom endpoint is the SRS-2 total score.
Secondary Outcomes
Secondary outcomes include self-reported measures of mental health and quality of life:
- PROMIS Depression subscale
- PROMIS Sleep measures (sleep disturbance and sleep-related impairment)
- WHOQOL-BREF quality of life measure
Physical Activity Monitoring (In-Session) To characterize activity levels during the intervention, wearable actigraphy (ActiGraph) is used to monitor movement intensity during pickleball classes on a bimonthly basis. The device is worn around the waist during class sessions and passively records movement without collecting audio, video, or location information.
Safety and Acceptability Monitoring Participants currently receiving the pickleball intervention complete brief bimonthly online check-ins (via REDCap) to monitor pain/injury and provide structured qualitative feedback.
Study Groups and Assessment Schedule
The delayed-control structure results in different assessment schedules depending on group assignment:
- Both randomized groups complete baseline testing and an immediate post-Phase 1 assessment.
- The delayed group completes a final post-intervention assessment after completing Phase 2.
- The early group completes an additional follow-up assessment after Phase 2 to examine whether changes persist after intervention completion.
In addition, the protocol allows continued enrollment during Phase 1 so that "late enrolled" participants can complete Phase 2 intervention participation and contribute to within-subject pre/post analyses, though not to the randomized Phase 1 comparison.
Sample Size and Accrual The study plans to enroll up to 50 participants to account for screen failures and attrition, with an expected completed sample of approximately 30-35 participants.
Planned Analytic Approach The study is designed to estimate the potential effectiveness of the pickleball program by comparing pre-to-post changes in primary and secondary outcomes. The Phase 1 randomized component supports a between-group comparison of change scores during the controlled period, while the delayed-start design also supports within-subject change analyses across participants who complete the intervention.
Study Setting Testing is conducted in community-based locations near the intervention sites to reduce participation barriers. Pickleball sessions are conducted at indoor community recreation facilities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a two-arm, parallel-group, delayed-start controlled trial design. Participants are randomized in a 1:1 ratio to either an Early Start intervention group or a Delayed Start group. Randomization is performed separately within each location to maintain balanced group allocation at each site. During Phase 1, the Early Start group participates in the 8-week pickleball intervention while the Delayed Start group continues usual activities. After completion of Phase 1 assessments, the Delayed Start group receives the same intervention during Phase 2. The Early Start group resumes usual activities during Phase 2 and completes an additional follow-up assessment to evaluate whether intervention-related changes are maintained beyond the initial intervention period.
| Arm | Type | Receives |
|---|---|---|
| Early Start Pickleball (Intervention) | Experimental | Behavioral: Pickleball Program (Community-Based)Participants assigned to this arm begin the community-based pickleball program immediately after baseline testing. They participate in supervised pickleball classes twice per week for 8 weeks (16 sessions total). Assessments are completed at baseline and after the Phase 1 intervention period. Participants then return to usual activities during Phase 2 and complete a follow-up assessment. |
| Delayed Start (Waitlist/Usual Activity Control) | Other | Behavioral: Pickleball Program (Community-Based)Participants assigned to this arm continue their usual activities during Phase 1 (no pickleball classes during this initial period). They complete baseline and post-Phase 1 assessments, then begin the same community-based pickleball program during Phase 2 (twice per week for 8 weeks; 16 sessions total). A final post-intervention assessment is completed after the Phase 2 intervention period. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Aged 18-45 years
- Clinical diagnosis of autism spectrum disorder (ASD)
- Able to participate in group-based activities without caregiver support
- Able to understand English and independently communicate without assistance
- Available for at least two sessions per week for the intervention dates
Key exclusion criteria (8 listed)
- Clinical diagnosis of intellectual disability (ID)
- Does not have normal or corrected-to-normal vision
- Actively participating in a racquet sport ≥1 time per week
- Use of mobility aids
- Moderate-to-severe joint pain (WOMAC pain subscale)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pickleball Program (Community-Based)Group-based beginner-friendly pickleball classes delivered in community indoor court facilities. Sessions occur twice per week for 8 weeks (16 sessions total), approximately 90 minutes per session, led by trained instructors. | Behavioural | Delayed Start (Waitlist/Usual Activity Control), Early Start Pickleball (Intervention) |
Primary outcome
Sensory-Motor Function (HaptiKart task outcomes)
Time frame: T1 (Week 0, enrollment) may occur up to 4 weeks prior to initiation of pickleball intervention; T2 approximately 10 weeks after baseline (up to 12 weeks); T3 approximately 18 weeks after baseline (up to 20 weeks).
Sensory-motor integration and proprioceptive bias measured using the HaptiKart videogame task.
Autism Symptom Severity (SRS-2 Total Score)
Time frame: T1 (Week 0, enrollment) may occur up to 4 weeks prior to initiation of pickleball intervention; T2 approximately 10 weeks after baseline (up to 12 weeks); T3 approximately 18 weeks after baseline (up to 20 weeks).
Core autism symptom severity measured by the Social Responsiveness Scale, 2nd edition (SRS-2), adult self-report, total score. The SRS-2 consists of 65 items rated on a 4-point Likert scale (1 = not true; 4 = almost always true). Raw total scores range from 0 to 195. Higher scores indicate greater severity of autism-related social impairment.
4 secondary outcomes
Depression Symptoms (PROMIS Depression)
Time frame: T1 (Week 0, enrollment) may occur up to 4 weeks prior to initiation of pickleball intervention; T2 approximately 10 weeks after baseline (up to 12 weeks); T3 approximately 18 weeks after baseline (up to 20 weeks).
Sleep-Related Impairment
Time frame: T1 (Week 0, enrollment) may occur up to 4 weeks prior to initiation of pickleball intervention; T2 approximately 10 weeks after baseline (up to 12 weeks); T3 approximately 18 weeks after baseline (up to 20 weeks).
Sleep Disturbance
Time frame: T1 (Week 0, enrollment) may occur up to 4 weeks prior to initiation of pickleball intervention; T2 approximately 10 weeks after baseline (up to 12 weeks); T3 approximately 18 weeks after baseline (up to 20 weeks).
Quality of Life (WHOQOL-BREF)
Time frame: T1 (Week 0, enrollment) may occur up to 4 weeks prior to initiation of pickleball intervention; T2 approximately 10 weeks after baseline (up to 12 weeks); T3 approximately 18 weeks after baseline (up to 20 weeks).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Background: PubMed 40531815Lidstone DE, Singhala M, Wang LJ, Brown JD, Mostofsky SH. HaptiKart: An engaging videogame reveals elevated proprioceptive bias in individuals with autism spectrum disorder. PLOS Digit Health. 2025 Jun 18;4(6):e0000879. doi: 10.1371/journal.pdig.0000879. eCollection 2025 Jun.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Not yet recruiting
Transdiagnostic Sleep and Circadian Treatment for Autistic Adolescents
Sleep, Autism Spectrum Disorder
RecruitingObservational study
Effectiveness of the Autism Pupil Screen (APS) Detect Pupillometer for Identifying Autism Spectrum Disorder (ASD) in Routine Healthcare
Autism Spectrum Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chris Sciammana, MD principal investigator
Penn State College of Medicine
Daniel E Lidstone, Ph.D. principal investigator
Penn State Harrisburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pickleball Program (Community-Based) in people with Autism Spectrum Disorder, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory-Motor Function (HaptiKart task outcomes) (time frame: T1 (Week 0, enrollment) may occur up to 4 weeks prior to initiation of pickleball intervention; T2 approximately 10 weeks after baseline (up to 12 weeks); T3 approximately 18 weeks after baseline (up to 20 weeks).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07432776, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.