NCT07747129

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
44mo left

Started Sep 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
not yet 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 Progress2%
Sep 2026May 2030

First Submitted

Initial submission to the registry

July 30, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 5, 2026

Completed
27 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2030

Last Updated

August 5, 2026

Status Verified

July 1, 2026

Enrollment Period

3.7 years

First QC Date

July 30, 2026

Last Update Submit

July 30, 2026

Conditions

Keywords

preschoolphysical activityteacherchildautismprofessional developmentonlineearly childhood education

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    Pre-Training (Week 0), Post-Training (Week 4), Follow-Up (Week 20)

Study Arms (2)

WE PLAY Group

EXPERIMENTAL
Behavioral: Wellness Enhancing Physical Activity for Young Children (WE PLAY)

Control Group

OTHER
Behavioral: Non-Physical Activity Online Training

Interventions

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.

WE PLAY Group

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.

Control Group

Eligibility Criteria

Age33 Months - 71 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Northeastern University

Boston, Massachusetts, 02115, United States

Location

Tufts University/Tufts Medical Center

Boston, Massachusetts, 02115, United States

Location

Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Autism Spectrum DisorderMotor ActivityAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersBehavior

Central Study Contacts

Jessica A. Hoffman, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2026

First Posted

August 5, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

May 1, 2030

Last Updated

August 5, 2026

Record last verified: 2026-07

Locations