NCT07432776

Brief 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. The main questions it aims to answer are:

  • 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1

Timeline
1mo left

Started Feb 2026

Shorter than P25 for early_phase_1

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 Progress68%
Feb 2026Jul 2026

Study Start

First participant enrolled

February 2, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

February 7, 2026

Last Update Submit

February 18, 2026

Conditions

Keywords

Autism Spectrum DisorderASDAutismAdultPickleballSensory-MotorSensorimotor

Outcome Measures

Primary Outcomes (2)

  • Sensory-Motor Function (HaptiKart task outcomes)

    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)

    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 Outcomes (4)

  • Depression Symptoms (PROMIS Depression)

    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

    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

    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)

    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 Outcomes (2)

  • Pickleball Skill Performance

    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)

    During selected pickleball sessions throughout the 8-week intervention period (Weeks 2, 4, 6, and 8 of the intervention).

Study Arms (2)

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.

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.

Behavioral: Pickleball Program (Community-Based)

Interventions

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.

Delayed Start (Waitlist/Usual Activity Control)Early Start Pickleball (Intervention)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Harrisburg

Middletown, Pennsylvania, 17011, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40531815BACKGROUND

Related Links

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Chris Sciammana, MD

    Penn State College of Medicine

    PRINCIPAL INVESTIGATOR
  • Daniel E Lidstone, Ph.D.

    Penn State Harrisburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 7, 2026

First Posted

February 25, 2026

Study Start

February 2, 2026

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

July 15, 2026

Last Updated

February 25, 2026

Record last verified: 2026-02

Locations