- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07421830
An Empowering Parent Training Intervention to Increase Physical Activity in Preschool Aged Children With Autism
An Empowering Parent Training Intervention to Increase Physical Activity in Preschool Aged Children With Autism: A Randomized Control Trial
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Haley V Medeiros, M.S./CAGs
- Phone Number: 5086540724
- Email: medeiros.ha@northeastern.edu
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02115
- Recruiting
- Northeastern University
-
Contact:
- Jessica Hoffman, PhD, NCSP
- Email: j.hoffman@northeastern.edu
-
Principal Investigator:
- Jessica Hoffman, PhD, NCSP
-
Sub-Investigator:
- Haley V Medeiros, MS, CAGs
-
Contact:
- Haley V Medeiros, MS/CAGs
- Phone Number: 617-373-5257
- Email: medeiros.ha@northeastern.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: WE PLAY for Parents Group
Participants in the WE PLAY for Parents Group will be asked to complete the intervention in the first two weeks of the study period.
|
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.
|
|
No Intervention: Control Group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Pre-Training in Parental Confidence in Promoting Physical Activity for their Children on the Preschool Parent Confidence Questionnaire (PPCQ) at Week 2
Time Frame: Pre-training (Week 0), Post-training (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
Time Frame: Pre-training (Week 0), Post-training (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
Time Frame: Pre-training (Week 0), Post-training (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
Time Frame: Pre-training (week 0), 3-month Follow-Up (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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Describe Acceptability, Understanding, and Feasibility of the WE PLAY for Parents Intervention with the Usage Rating Profile-Intervention Revised (URP-IR) at Post-Training
Time Frame: Post-training (Week 2)
|
The URP-IR assesses intervention acceptability (7 items), understanding (3 items), and feasibility (6 items).
Items are rated using a 6-point scale with higher scores reflecting greater likelihood of intervention adoption and use (α = 0.72-0.95)
(Briesch et al., 2013).
|
Post-training (Week 2)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jessica Hoffman, PhD, NCSP, Northeastern University
Publications and helpful links
General Publications
- Enders, C. K. (2010). Applied missing data analysis. Guilford Press.
- 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
- 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
- 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.
- 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
- 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
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB#25-12-22
- 26-C-01055 (Other Identifier: Northeastern University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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