Autism Spectrum Disorder (ASD)NCT07747129
Promoting Physical Activity Among Young Children With Autism
A study testing Wellness Enhancing Physical Activity for Young Children (WE PLAY) and Non-Physical Activity Online Training in people with Autism Spectrum Disorder (ASD), run by Northeastern University at 3 sites in United States.
Trial summary
Higher amounts of physical activity are linked to multiple health benefits including improved cognition, academic success, and classroom behavior for children. These relationships start in early childhood during the preschool years. Read more about this study
- Who is it for?
- Ages 33 to 71 months
- Conditions the study is for
- Autism Spectrum Disorder (ASD)
- What is being tested?
- Wellness Enhancing Physical Activity for Young Children (WE PLAY) and Non-Physical Activity Online Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2026to May 2030
- Phase
- Interventional
- 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 33 to 71 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Only 1 teacher-child dyad per early childhood education program/school will be enrolled in the study.
- Teachers are eligible to participate if: they are a lead teacher in a classroom with at least one child with autism; the autistic child's parent/guardian consented for their child to participate; and the teacher has not previously completed WE PLAY.
- Children are eligible to participate if: they are between the ages of 2.9 - 5.11 years at the pre-training assessment, they have a previous diagnosis of autism, and their teacher is participating.
Who cannot join
- Children who do not have a diagnosis of autism, or whose family plans to move away from the area before the study ends will be excluded from the study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Northeastern University
Boston, Massachusetts, 02115
Jessica A. Hoffman, PhD, 617-373-5257, j.hoffman@northeastern.edu
Tufts University/Tufts Medical Center
Boston, Massachusetts, 02115
Angie M. Rodday, PhD, 617-636-7193, angie.rodday@tufts.edu
Pennsylvania State University
University Park, Pennsylvania, 16802
Benjamin Bayly, PhD, 800-452-9108, blb339@psu.edu
About this study
Higher amounts of physical activity are linked to multiple health benefits including improved cognition, academic success, and classroom behavior for children. These relationships start in early childhood during the preschool years. Additional research is needed to determine the rates of physical activity among children with autism spectrum disorder. However, research suggests that compared to their typically developing peers, children with autism participate in fewer types of physical activities, often have delays in a range of motor skills, and face physical activity barriers including behavior problems, social communication challenges, and adults' uncertainty about how to modify physically active games to include them. Young children need adult guidance, support, and opportunities to be more active, and early care and education programs are a critical setting for physical activity promotion.
Faculty at Northeastern University developed and pilot tested WE PLAY (Wellness Enhancing Physical Activity for Young Children), a teacher training, that is accessed online at no cost. WE PLAY was designed to promote physical activity at the child-level, to promote knowledge, confidence, and skills to lead active play at the teacher-level, and to impact social and environmental challenges at the program-level. Three three pilot studies demonstrated that WE PLAY was efficacious in increasing physical activity when implemented with preschoolers with and without autism and it was viewed as feasible, understandable, and acceptable by early childhood educators.
Read more
This clinical trial will test the efficacy of WE PLAY in children with autism spectrum disorder and their teachers. The researchers hypothesized that at post-training and follow-up, children in the WE PLAY group will engage in higher levels of physical activity in school relative to children in the control group. Further, the researchers hypothesized that at post-training and follow-up teachers in the WE PLAY group will demonstrate increased behavior intentions, perceived behavior control to perform physical activity facilitating behaviors relative to control group teachers. Additionally, this study will explore the effects of malleable teacher and system-level factors between the intervention and child physical activity. The researchers hypothesized that malleable teacher and system variables including behavior intentions, perceived behavior control, physical activity promotion practices, teachers' perceived physical activity promotion role, teacher autonomy, and supervisor support will mediate or moderate the relationship between study group and child physical activity levels.
A national sample of 150 teacher-child dyads from early childhood education programs across the United States will be randomized into two conditions (WE PLAY vs. Control). Data will be collected across three periods over 20 weeks (pre-training = 0 weeks, post-training = 4 weeks, follow-up = 20 weeks). WE PLAY teachers will be asked to complete the WE PLAY training. Control group teachers will complete another online training on a topic that is not related to physical activity. Children with autism (ages 2.9 to 5.11) will wear accelerometers during waking hours for five consecutive days at each of the three data collection periods and their teachers will complete online surveys at each of the three data collection periods.
The proposed study addresses a critical need for young children with autism. If WE PLAY is determined to be efficacious on a large scale it would lead to interventions that could be integrated in a variety of settings, including early care and education programs and community settings, which could improve physical activity levels in young children, setting them up for greater success throughout their lives.
- Conditions
- Autism Spectrum Disorder (ASD)
- Being tested
- Wellness Enhancing Physical Activity for Young Children (WE PLAY), Non-Physical Activity Online Training
- Keywords
- preschool, physical activity, teacher, child, autism, professional development, online, early childhood education
- Medical subject headings
- Autism Spectrum Disorder, Motor Activity, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellness Enhancing Physical Activity for Young Children (WE PLAY)Behavioural
WE PLAY Is an online training for early childhood educators. The training includes online educational modules, a video library of active games, game sheets, a teacher self-assessment, a supervisor/peer observation form, and other resources/tools designed to include autistic preschoolers in active play with their peers.
Non-Physical Activity Online TrainingBehavioural
Participants in this group will complete an online training from a list of options on the Better Kid Care website that are not on the topic of physical activity.
| Study group | Role | What they receive |
|---|---|---|
| WE PLAY Group | Experimental | Not described Receives: Behavioral: Wellness Enhancing Physical Activity for Young Children (WE PLAY) |
| Control Group | Other | Not described Receives: Behavioral: Non-Physical Activity Online Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Pre-Training in Children's Physical Activity Assessed by Accelerometry at Post-training and Follow-Up
Accelerometry will be used to assess children's physical activity. ActiGraph wGT3X-BT accelerometers will be used to collect data for 5 school days at each data collection period. Data will be analyzed using validated accelerometer count cut-points for preschoolers (sedentary < 200 counts per 15 seconds; light physical activity (PA) = 200-419 counts per 15 seconds; moderate-to-vigorous physical activity (MVPA) ≥420 counts per 15 seconds). The 5 days of accelerometry data will be averaged together. Data on children with <3 days of data will be excluded from the time period. The dependent variable will be total PA minutes per hour wear time.
Measured: Pre-Training (Week 0), Post-Training (Week 4), Follow-Up (Week 20)
Change from Pre-Training in Teachers' Behavioral Intentions as Assessed by an abbreviated version of the Early Childhood Education Movement Behavioral Intention and Perceived Control (ECE-MBIPC) Questionnaire at Post-Training and Follow-Up
Ten items from the ECE-MBIPC will be used to measure participants' intentions to perform five behaviors related to physical activity. Intentions to perform each behavior are measured using two items per behavior which participants rate using a 7-point scale (ranging from 1=extremely unlikely to 7=extremely likely). A behavioral intention composite score for each behavior is calculated by computing a mean for the two items. Five behavior intention composite scores (1 score per behavior) will be computed with higher scores indicating stronger intentions to perform the behavior.
Measured: Pre-Training (Week 0), Post-Training (Week 4), Follow-Up (Week 20)
Change from Pre-Training in Teachers' Perceived Behavioral Control as Assessed by the ECE-MBIPC at Post-Training and Follow-Up
Twenty items from the ECE-MBIPC will be used to measure participants' perceived control to perform five behaviors related to physical activity. Control over performing each behavior is measured using four items per behavior which participants rate using a 7-point scale (ranging from 1=extremely unlikely to 7=extremely likely). A perceived behavioral control composite score for each behavior is calculated by computing a mean for the four items. Five perceived behavior control composite scores (1 score per behavior) will be computed with high scores indicating higher levels of perceived control over performing the behavior.
Measured: Pre-Training (Week 0), Post-Training (Week 4), Follow-Up (Week 20)
Change from Pre-Training in Teachers' Practices to Promote Physical Activity as Assessed by the Child-Care Food and Activity Practices Questionnaire (CFAPQ) at Post-Training and Follow-Up
Two subscales from the CFAPQ (Modeling and Teaching/Autonomy Support) will be used to measure participants' physical activity promotion practices. The Modeling subscale includes seven items and the Teaching/Autonomy Support subscale includes five items. Items are rated using a 5-point scale (1-never to 5 = always). Mean subscale scores will be computed with higher scores indicating more frequent use of physical activity promotion practices.
Measured: Pre-Training (Week 0), Post Training (Week 4), Follow Up (Week 20)
Change from Pre-Training in Teachers' Practices to Promote Physical Activity as Assessed by the Environment and Policy Assessment and Observation Self-Report Staff General Survey (EPAO-SR) at Post-Training and Follow-Up
Eleven physical activity best practices from the EPAO-SR will be rated on a 6-point scale (ranging from 1=never to 6=always). A mean score will be computed with higher scores indicating more frequent use of physical activity promotion practices.
Measured: Pre-Training (Week 0), Post-Training (Week 4), Follow-Up (Week 20)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Disorder (ASD)Studies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University, Tufts Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747129
- Sponsor's protocol ID
- 24-08-02
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Physical Activity Among Young Children With Autism
- ClinicalTrials.gov ID
- NCT07747129
- Acronym / sponsor ID
- 24-08-02
- Conditions
- Autism Spectrum Disorder (ASD)
- Keywords
- preschool, physical activity, teacher, child, autism, professional development, online, early childhood education
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Northeastern UniversityUniversity, hospital or other
- Collaborators
- Penn State University, Tufts Medical Center
- Study start
- Sep 2026 (estimated)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 5 Aug 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.
Higher amounts of physical activity are linked to multiple health benefits including improved cognition, academic success, and classroom behavior for children. These relationships start in early childhood during the preschool years. Additional research is needed to determine the rates of physical activity among children with autism spectrum disorder. However, research suggests that compared to their typically developing peers, children with autism participate in fewer types of physical activities, often have delays in a range of motor skills, and face physical activity barriers including behavior problems, social communication challenges, and adults' uncertainty about how to modify physically active games to include them. Young children need adult guidance, support, and opportunities to be more active, and early care and education programs are a critical setting for physical activity promotion.
Faculty at Northeastern University developed and pilot tested WE PLAY (Wellness Enhancing Physical Activity for Young Children), a teacher training, that is accessed online at no cost. WE PLAY was designed to promote physical activity at the child-level, to promote knowledge, confidence, and skills to lead active play at the teacher-level, and to impact social and environmental challenges at the program-level. Three three pilot studies demonstrated that WE PLAY was efficacious in increasing physical activity when implemented with preschoolers with and without autism and it was viewed as feasible, understandable, and acceptable by early childhood educators.
This clinical trial will test the efficacy of WE PLAY in children with autism spectrum disorder and their teachers. The researchers hypothesized that at post-training and follow-up, children in the WE PLAY group will engage in higher levels of physical activity in school relative to children in the control group. Further, the researchers hypothesized that at post-training and follow-up teachers in the WE PLAY group will demonstrate increased behavior intentions, perceived behavior control to perform physical activity facilitating behaviors relative to control group teachers. Additionally, this study will explore the effects of malleable teacher and system-level factors between the intervention and child physical activity. The researchers hypothesized that malleable teacher and system variables including behavior intentions, perceived behavior control, physical activity promotion practices, teachers' perceived physical activity promotion role, teacher autonomy, and supervisor support will mediate or moderate the relationship between study group and child physical activity levels.
A national sample of 150 teacher-child dyads from early childhood education programs across the United States will be randomized into two conditions (WE PLAY vs. Control). Data will be collected across three periods over 20 weeks (pre-training = 0 weeks, post-training = 4 weeks, follow-up = 20 weeks). WE PLAY teachers will be asked to complete the WE PLAY training. Control group teachers will complete another online training on a topic that is not related to physical activity. Children with autism (ages 2.9 to 5.11) will wear accelerometers during waking hours for five consecutive days at each of the three data collection periods and their teachers will complete online surveys at each of the three data collection periods.
The proposed study addresses a critical need for young children with autism. If WE PLAY is determined to be efficacious on a large scale it would lead to interventions that could be integrated in a variety of settings, including early care and education programs and community settings, which could improve physical activity levels in young children, setting them up for greater success throughout their lives.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WE PLAY Group | Experimental | Behavioral: Wellness Enhancing Physical Activity for Young Children (WE PLAY) |
| Control Group | Other | Behavioral: Non-Physical Activity Online Training |
Who may qualify
- Ages
- 33 to 71 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Only 1 teacher-child dyad per early childhood education program/school will be enrolled in the study.
- Teachers are eligible to participate if: they are a lead teacher in a classroom with at least one child with autism; the autistic child's parent/guardian consented for their child to participate; and the teacher has not previously completed WE PLAY.
- Children are eligible to participate if: they are between the ages of 2.9 - 5.11 years at the pre-training assessment, they have a previous diagnosis of autism, and their teacher is participating.
Key exclusion criteria (1 listed)
- Children who do not have a diagnosis of autism, or whose family plans to move away from the area before the study ends will be excluded from the study.
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 |
|---|---|---|
| Wellness Enhancing Physical Activity for Young Children (WE PLAY)WE PLAY Is an online training for early childhood educators. The training includes online educational modules, a video library of active games, game sheets, a teacher self-assessment, a supervisor/peer observation form, and other resources/tools designed to include autistic preschoolers in active play with their peers. | Behavioural | WE PLAY Group |
| Non-Physical Activity Online TrainingParticipants in this group will complete an online training from a list of options on the Better Kid Care website that are not on the topic of physical activity. | Behavioural | Control Group |
Primary outcome
Change from Pre-Training in Children's Physical Activity Assessed by Accelerometry at Post-training and Follow-Up
Time frame: Pre-Training (Week 0), Post-Training (Week 4), Follow-Up (Week 20)
Accelerometry will be used to assess children's physical activity. ActiGraph wGT3X-BT accelerometers will be used to collect data for 5 school days at each data collection period. Data will be analyzed using validated accelerometer count cut-points for preschoolers (sedentary < 200 counts per 15 seconds; light physical activity (PA) = 200-419 counts per 15 seconds; moderate-to-vigorous physical activity (MVPA) ≥420 counts per 15 seconds). The 5 days of accelerometry data will be averaged together. Data on children with <3 days of data will be excluded from the time period. The dependent variable will be total PA minutes per hour wear time.
Change from Pre-Training in Teachers' Behavioral Intentions as Assessed by an abbreviated version of the Early Childhood Education Movement Behavioral Intention and Perceived Control (ECE-MBIPC) Questionnaire at Post-Training and Follow-Up
Time frame: Pre-Training (Week 0), Post-Training (Week 4), Follow-Up (Week 20)
Ten items from the ECE-MBIPC will be used to measure participants' intentions to perform five behaviors related to physical activity. Intentions to perform each behavior are measured using two items per behavior which participants rate using a 7-point scale (ranging from 1=extremely unlikely to 7=extremely likely). A behavioral intention composite score for each behavior is calculated by computing a mean for the two items. Five behavior intention composite scores (1 score per behavior) will be computed with higher scores indicating stronger intentions to perform the behavior.
Change from Pre-Training in Teachers' Perceived Behavioral Control as Assessed by the ECE-MBIPC at Post-Training and Follow-Up
Time frame: Pre-Training (Week 0), Post-Training (Week 4), Follow-Up (Week 20)
Twenty items from the ECE-MBIPC will be used to measure participants' perceived control to perform five behaviors related to physical activity. Control over performing each behavior is measured using four items per behavior which participants rate using a 7-point scale (ranging from 1=extremely unlikely to 7=extremely likely). A perceived behavioral control composite score for each behavior is calculated by computing a mean for the four items. Five perceived behavior control composite scores (1 score per behavior) will be computed with high scores indicating higher levels of perceived control over performing the behavior.
Change from Pre-Training in Teachers' Practices to Promote Physical Activity as Assessed by the Child-Care Food and Activity Practices Questionnaire (CFAPQ) at Post-Training and Follow-Up
Time frame: Pre-Training (Week 0), Post Training (Week 4), Follow Up (Week 20)
Two subscales from the CFAPQ (Modeling and Teaching/Autonomy Support) will be used to measure participants' physical activity promotion practices. The Modeling subscale includes seven items and the Teaching/Autonomy Support subscale includes five items. Items are rated using a 5-point scale (1-never to 5 = always). Mean subscale scores will be computed with higher scores indicating more frequent use of physical activity promotion practices.
Change from Pre-Training in Teachers' Practices to Promote Physical Activity as Assessed by the Environment and Policy Assessment and Observation Self-Report Staff General Survey (EPAO-SR) at Post-Training and Follow-Up
Time frame: Pre-Training (Week 0), Post-Training (Week 4), Follow-Up (Week 20)
Eleven physical activity best practices from the EPAO-SR will be rated on a 6-point scale (ranging from 1=never to 6=always). A mean score will be computed with higher scores indicating more frequent use of physical activity promotion practices.
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 5 Aug 2026.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wellness Enhancing Physical Activity for Young Children (WE PLAY) and Non-Physical Activity Online Training in people with Autism Spectrum Disorder (ASD), run by Northeastern University at 3 sites 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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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?
Contact Jessica A. Hoffman, PhD (617-373-5257, j.hoffman@northeastern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Pre-Training in Children's Physical Activity Assessed by Accelerometry at Post-training and Follow-Up (time frame: Pre-Training (Week 0), Post-Training (Week 4), Follow-Up (Week 20)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2026.