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NCT Number: NCT07747129

Promoting Physical Activity Among Young Children With Autism

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.

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Key information

Conditions

Autism Spectrum Disorder (ASD) Autism Spectrum Disorder Autistic Disorder Behavior Child Development Disorders, Pervasive Mental Disorders Motor Activity Neurodevelopmental Disorders

Age range

33 month–71 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northeastern University, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Wellness Enhancing Physical Activity for Young Children (WE PLAY)

Behavioral

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 Training

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica A. Hoffman, PhD

CONTACT

[email protected]

617-373-5257

Sponsors and collaborators

Lead sponsor

Northeastern University

Other

Collaborators

  • Penn State University
  • Tufts Medical Center

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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