NCT07421830

Brief Summary

The goal of this clinical trial is to learn if WE PLAY for Parents can improve caregivers' knowledge, attitudes, confidence, and skills promoting physical activity with their young child with autism. The main questions it aims to answer are: (1) Do participants who complete WE PLAY for Parents improve their knowledge, behavior intentions, perceived behavior control, self-efficacy, and parenting practices related to physical activity promotion with their child (Primary Hypotheses); and (2) Do participants view WE PLAY for Parents as acceptable, understandable, and feasible \[secondary hypothesis)? Researchers will compare the WE PLAY for Parents group \[experimental arm\] to a Waitlist Control group to see if there are differences in the variables listed in the primary hypothesis. Participants will: (1) Complete a set of questionnaires at three timepoints: pre-training, post-training, and 3-month follow-up that each take between 10-15 minutes; (2) be randomly assigned to take the training over the next two weeks or be offered the training after 3 months. The online training takes about 90 minutes. It includes watching informational videos, viewing video clips of adults helping children be active, reading handouts on behavior management tips and social stories, participating in an anonymous discussion board with other parents, and completing a self-assessment.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Feb 2026

Shorter than P25 for not_applicable

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 Progress37%
Feb 2026Dec 2026

First Submitted

Initial submission to the registry

February 5, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

February 20, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

February 5, 2026

Last Update Submit

April 6, 2026

Conditions

Keywords

parentsautismphysical activitypreschoolershealth promotionactive playcaregivers

Outcome Measures

Primary Outcomes (4)

  • Change from Pre-Training in Parental Confidence in Promoting Physical Activity for their Children on the Preschool Parent Confidence Questionnaire (PPCQ) at Week 2

    The PPCQ is a 17-item, self-report instrument measuring parental confidence in promoting physical activity for their children (Coleman, 2010). The 17 items are rated 0 (not confident)-10 (totally confident), yielding a total score (0-170) with higher scores indicating higher parental self-efficacy. The PPCQ demonstrates strong reliability (α = 0.92-0.94).

    Pre-training (Week 0), Post-training (Week 2)

  • Change from Pre-Training in Parental Physical Activity Knowledge at Week 2

    The physical activity knowledge test measures parental knowledge of physical activity promotion among young children with autism. The measure contains 10 multiple-choice items that were developed based on content from the WE PLAY for Parents online intervention. Scores range from 0-10 with higher scores indicating stronger knowledge.

    Pre-training (Week 0), Post-training (Week 2)

  • Change from Pre-Training in Parental Behavioral Intention and Perceived Behavioral Control on the Adapted Early Childhood Educator Movement Behavioral Intention and Perceived Control Questionnaire (ECE-MBIPC) at Week 2

    An adapted version of the validated ECE-MBIPC assesses behavior intentions and perceived behavior control over five physical activity-related behaviors. The 10 items are rated using a 7-point, Likert-type scale, and generate composite scores for behavioral intention (5 items) and perceived control (5 items), with higher scores indicating greater likelihood of engagement. Composite scores range from 0-35 for behavioral intention and perceived control. The ECE-MBIPC questionnaire shows high internal consistency (Cronbach's alpha \> 0.85 across subscales) (Bruijns et al., 2023).

    Pre-training (Week 0), Post-training (Week 2)

  • Change from Pre-Training in Parental Physical Activity Promotion Practices on the Preschooler Physical Activity Parenting Practices (PPAPP) at Week 14

    The Engagement subscale of the PPAPP measures parental encouragement of physical activity. This subscale includes 15 items that are rated using a 5-point scale. Scores range from 0-75 and higher scores indicate more frequent PA-promoting practices. Cronbach's α values= 0.87-0.92 (O'Connor et al., 2014).

    Pre-training (week 0), 3-month Follow-Up (week 14).

Secondary Outcomes (1)

  • Describe Acceptability, Understanding, and Feasibility of the WE PLAY for Parents Intervention with the Usage Rating Profile-Intervention Revised (URP-IR) at Post-Training

    Post-training (Week 2)

Study Arms (2)

WE PLAY for Parents Group

EXPERIMENTAL

Participants in the WE PLAY for Parents Group will be asked to complete the intervention in the first two weeks of the study period.

Behavioral: Wellness Enhancing Physical Activity for Young Children: Parent Version (WE PLAY for Parents)

Control Group

NO INTERVENTION

Participants in the Waitlist Control group will be given access to the WE PLAY for Parents training after their study data collection is complete. This group will not receive any intervention during the data collection period.

Interventions

WE PLAY for Parents is an online intervention that includes an asynchronous online training with written material about physical activity promotion. Users view video clips of adults promoting active play with young children, review handouts with behavior management tips and social stories, participate in an anonymized discussion board with other parent participants, and complete a self-assessment. Intervention completion is takes between 1.5 to 2 hours.

WE PLAY for Parents Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parents or caregivers (who are at least 18 years of age) of children with a diagnosis of autism.
  • The autism diagnosis for the child can be from a school or medical setting.
  • The parent or caregiver's child with autism must be between 2 years 11 months and 5 years, 11 months of age.
  • Parent or caregivers must be able to read and write in English.

You may not qualify if:

  • Parents or caregivers who do not have a child with autism.
  • Adults who do not have children.
  • Parents or caregivers who cannot read and write in English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northeastern University

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (21)

  • Enders, C. K. (2010). Applied missing data analysis. Guilford Press.

    BACKGROUND
  • Ajzen, I. (1991). The theory of planned behavior. Organizational Behavior and Human Decision Processes, 50(2), 179-211. https://doi.org/10.1016/0749-5978(91)90020-T

    RESULT
  • Agard B, Zeng N, McCloskey ML, Johnson SL, Bellows LL. Moving Together: Understanding Parent Perceptions Related to Physical Activity and Motor Skill Development in Preschool Children. Int J Environ Res Public Health. 2021 Aug 31;18(17):9196. doi: 10.3390/ijerph18179196.

  • Barry A, Ku B, Swarup G, Christensen LA, Columna L. Psychological factors of parental physical activity support among parents of children with disabilities: a meta-analysis. Disabil Rehabil. 2025 May;47(10):2503-2511. doi: 10.1080/09638288.2024.2399222. Epub 2024 Sep 11.

  • Briesch AM, Chafouleas SM, Neugebauer SR, Riley-Tillman TC. Assessing influences on intervention implementation: revision of the usage rating profile-intervention. J Sch Psychol. 2013 Feb;51(1):81-96. doi: 10.1016/j.jsp.2012.08.006. Epub 2012 Sep 20.

  • Bruijns, B. A., Johnson, A. M., Burke, S. M., & Tucker, P. (2023). Validation of a physical activity, sedentary behavior, and outdoor play behavioral intention and perceived behavioral control tool for early childhood educators. Early Childhood Education Journal, 51(3), 559-567. https://doi.org/10.1007/s10643-022-01314-5

    RESULT
  • Carson V, Lee EY, Hewitt L, Jennings C, Hunter S, Kuzik N, Stearns JA, Unrau SP, Poitras VJ, Gray C, Adamo KB, Janssen I, Okely AD, Spence JC, Timmons BW, Sampson M, Tremblay MS. Systematic review of the relationships between physical activity and health indicators in the early years (0-4 years). BMC Public Health. 2017 Nov 20;17(Suppl 5):854. doi: 10.1186/s12889-017-4860-0.

  • Coleman, M. B. (2010). Development and validation of the Preschool Parent Confidence Questionnaire (PPCQ): A parental self-efficacy instrument (Unpublished master's thesis). Northern Illinois University, IL.

    RESULT
  • Columna L, Meera B, Prieto LA, Haegele JA. The perceived influence of a physical activity intervention on the intentions of parents of autistic children towards physical activities. Disabil Health J. 2024 Oct;17(4):101637. doi: 10.1016/j.dhjo.2024.101637. Epub 2024 Apr 30.

  • Finch M, Jones J, Yoong S, Wiggers J, Wolfenden L. Effectiveness of centre-based childcare interventions in increasing child physical activity: a systematic review and meta-analysis for policymakers and practitioners. Obes Rev. 2016 May;17(5):412-28. doi: 10.1111/obr.12392. Epub 2016 Mar 23.

  • Goldstein NE, Kemp KA, Leff SS, Lochman JE. Guidelines for Adapting Manualized Interventions for New Target Populations: A Step-Wise Approach Using Anger Management as a Model. Clin Psychol (New York). 2012 Dec 1;19(4):385-401. doi: 10.1111/cpsp.12011.

  • Ha AS, He Q, Lubans DR, Chan CH, Ng JYY. Parent-focused online intervention to promote parents' physical literacy and support children's physical activity: results from a quasi-experimental trial. BMC Public Health. 2022 Jul 12;22(1):1330. doi: 10.1186/s12889-022-13739-z.

  • He, Q., Ha, A. S. C., Ng, J. Y. Y., Cairney, J., & Bedard, C. (2022). Associations between parent perceived social cognitive factors and child objectively measured physical activity behaviors among preschool-aged children. Psychology of Sport and Exercise, 61, 102200. https://doi.org/10.1016/j.psychsport.2022.102200

    RESULT
  • Hnatiuk JA, Brown HE, Downing KL, Hinkley T, Salmon J, Hesketh KD. Interventions to increase physical activity in children 0-5 years old: a systematic review, meta-analysis and realist synthesis. Obes Rev. 2019 Jan;20(1):75-87. doi: 10.1111/obr.12763. Epub 2018 Sep 26.

  • Hyman SL, Levy SE, Myers SM; COUNCIL ON CHILDREN WITH DISABILITIES, SECTION ON DEVELOPMENTAL AND BEHAVIORAL PEDIATRICS. Identification, Evaluation, and Management of Children With Autism Spectrum Disorder. Pediatrics. 2020 Jan;145(1):e20193447. doi: 10.1542/peds.2019-3447. Epub 2019 Dec 16.

  • Ku B, MacDonald M, Hatfield B, Gunter K. Parental Influence on the Physical Activity Behaviors of Young Children With Developmental Disabilities. Adapt Phys Activ Q. 2020 Sep 24;37(4):441-460. doi: 10.1123/apaq.2019-0120. Print 2020 Oct 1.

  • O'Connor TM, Cerin E, Hughes SO, Robles J, Thompson DI, Mendoza JA, Baranowski T, Lee RE. Psychometrics of the preschooler physical activity parenting practices instrument among a Latino sample. Int J Behav Nutr Phys Act. 2014 Jan 15;11:3. doi: 10.1186/1479-5868-11-3.

  • Schmidt, E., Hoffman, J., Mulé, C., & Briesch, A. (2023). Adapting a preschool physical activity intervention to be inclusive of children on the autism spectrum. International Journal of Disability, Development and Education, 1-19. https://doi.org/10.1080/1034912X.2023.2291575

    RESULT
  • Schmidt EM, Hoffman JA, Mule C, Briesch A. Effects of a teacher training program to promote physically active play among preschoolers with autism spectrum disorders. J Sch Psychol. 2021 Apr;85:57-79. doi: 10.1016/j.jsp.2021.01.003. Epub 2021 Feb 13.

  • Hoffman JA, Schmidt EM, Castaneda-Sceppa C, Hillman CH. The theoretical foundation, fidelity, feasibility, and acceptability of a teacher training to promote physical activity among preschoolers in child care: A pilot study. Prev Med Rep. 2019 Jan 9;13:214-217. doi: 10.1016/j.pmedr.2019.01.003. eCollection 2019 Mar.

  • Hoffman JA, Schmidt EM, Arguello DJ, Eyllon MN, Castaneda-Sceppa C, Cloutier G, Hillman CH. Online preschool teacher training to promote physical activity in young children: A pilot cluster randomized controlled trial. Sch Psychol. 2020 Mar;35(2):118-127. doi: 10.1037/spq0000349. Epub 2020 Jan 9.

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic DisorderMotor Activity

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersBehavior

Study Officials

  • Jessica Hoffman, PhD, NCSP

    Northeastern University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haley V Medeiros, M.S./CAGs

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a waitlist control RCT design. The waitlist group will receive access to the intervention (WE PLAY for Parents) at the end of their study participation (after the final data point is collected at the 3-month follow-up survey).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2026

First Posted

February 19, 2026

Study Start

February 20, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Only fully-anonymized data will be used for future research or shared with other researchers for their own studies.

Locations