- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07432776
Effect of an 8-Week Pickleball Program for Adults With Autism: A Feasibility Trial With a Delayed-Control Design
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:
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Middletown, Pennsylvania, United States, 17011
- Recruiting
- Penn State Harrisburg
-
Contact:
- Daniel E Lidstone, Ph.D.
- Phone Number: 828-719-7002
- Email: dbl5689@psu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Early Start Pickleball (Intervention)
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.
|
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.
|
|
Other: Delayed Start (Waitlist/Usual Activity Control)
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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)
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
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.
|
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).
|
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.
|
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).
|
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.
|
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).
|
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.
|
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).
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pickleball Skill Performance
Time Frame: At the first attended pickleball session (initiation of the 8-week intervention) and at the final pickleball session (completion of the 8-week intervention; approximately Week 8).
|
Pickleball performance measured using a structured ball-return assessment with coach fed-ball trials and scored for accuracy and paddle contact quality.
|
At the first attended pickleball session (initiation of the 8-week intervention) and at the final pickleball session (completion of the 8-week intervention; approximately Week 8).
|
|
Physical Activity During Sessions (ActiGraph)
Time Frame: During selected pickleball sessions throughout the 8-week intervention period (Weeks 2, 4, 6, and 8 of the intervention).
|
Physical activity level during pickleball sessions measured using wearable accelerometry (ActiGraph).
|
During selected pickleball sessions throughout the 8-week intervention period (Weeks 2, 4, 6, and 8 of the intervention).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chris Sciammana, MD, Penn State College of Medicine
- Principal Investigator: Daniel E Lidstone, Ph.D., Penn State Harrisburg
Publications and helpful links
General Publications
- Lidstone DE,Singhala M,Wang LJ,Brown JD,Mostofsky SH
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00027574
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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