A Multisystem, Multimodal Intervention for Children With ASD
Phase: NA
Conditions: Autism Spectrum Disorder
Sponsor: University of Delaware

 
 
 
 
 
Study Title: The Effect of Play on Social and Motor Skills of Children With ASD 
NCT #: NCT04258254 
Date: 06/01/2020 

Study Protocol 
Participants 
45 children with ASD aged between 5 and 15 years were recruited through fliers distributed to local schools, 
ASD services, advocacy groups, as well as Simons Powering Autism Research (SPARK) participant-
research matching service (https://www.sfari.org/resource/spark/). We interviewed the potential 
participants to gather their demographic information (i.e., age, sex, ethnicity), and to confirm their 
eligibility for participation. Children were included in the study if they had formal ASD diagnoses that were 
confirmed through a school record (e.g., school psychologist record confirming an ASD diagnosis) and/or 
an Individualized Education Plan for ASD-related services or a medical or neuropsychological record from 
a psychiatrist or clinical psychologist using the Autism Diagnostic Observation Schedule (ADOS) and/or 
Autism Diagnostic Interview-Revised (ADI-R) measures. We additionally used the Social Communication 
Questionnaire (SCQ) as a screener for ASD symptoms (Rutter et al., 2003). Children were excluded if they 
have limited comprehension of one-step simple instruction and/or could not complete the pretests due to 
behavioral issues. Parents of the children completed the Vineland Adaptive Behavioral Scales-2nd edition 
(VABS; Sparrow et al., 2005), and the Social Responsive Scale questionnaire (SRS; Constantino et al., 
2000) to assess the child’s adaptive functions and social responsiveness. Following enrollment, children 
were matched on age, sex, and level of functioning then randomly allocated to the 3 intervention arms.  
The study procedures were carried out according to the Declaration of Helsinki and were approved by the 
University of Delaware Institutional Review Board (UD IRB, Study Approval #: 1539736-5). Written 
informed consent of study participation was obtained from the parent, and a written/verbal assent was 
obtained from the participating children.  
Experimental Procedures 
This study includes 3 pretests, 3 posttests, and 16 training sessions conducted over 10 weeks. Eight weeks 
later a follow-up test was also completed. Specifically, the pretests and posttests were conducted during the 
first and the last week of the study, while the training sessions were provided during the intermediate 8 

weeks (2 sessions per week). After pretests, the children were matched age, sex, and level of functioning 
and then randomized into the 3 groups. A parent orientation was conducted in-person/ through zoom before 
the training period to introduce the training activities and intervention strategies. Each training session 
lasted about one hour. All sessions were video recorded for further behavioral coding. The current study 
was conducted in the midst of the COVID-19 pandemic (between 2019 and 2022). Due to the initial close 
down and the later restriction of face-to-face (F2F) interaction, we decided to be more pragmatic and used 
a hybrid clinical trial delivery model (Bhat et al., 2021; Cleffi et al., 2022; Srinivasan et al., 2021; Su et al., 
2021). The participating families chose between an F2F or a Telehealth (TH) training delivery method 
based on their convenience and comfort level of social interactions during the pandemic.  
Training Protocols 
For each intervention arm, Applied Behavior Analysis (ABA), Picture Exchange Communication System 
(PECS), TEACCH, and motor learning principles were used to provide structure, reinforcement, and free 
time for exploration. Specifically, visual, verbal, manual prompts/assistance, positive reinforcements were 
given throughout the intervention, and the child was encouraged to choose from a set of actions or improvise 
their own movement patterns. We also used a picture schedule to explain the order of tasks and to provide 
more structure to the session. During the training session, people sat/stood in a triad involving the child, 
expert trainer, and an adult model/parent was used. The expert trainer guided the child through the training-
specific activities, while the model/parent assisted and acted as a buddy to provide visual model/assistance 
for the children. For the F2F intervention delivery format, a trained undergraduate student acted as the 
model, while for the TH format, the parents were trained to aid during the intervention. Both, undergraduate 
students and parents were provided in-person/Zoom trainings to explain the training goals, intervention 
principles, and the main activities according to the intervention types. The key ingredients for the 
multimodal group included engaging in interpersonal synchrony and multi-limb, whole-body movements 
performed to music, while the general movement group received multi-limb, whole-body movements based 
in exercise and games; whereas the seated play, control group focused on reading and fine motor activities.  

To ensure training fidelity, a student coder randomly chose and coded one early (session 1-5) and one late 
session (session 12-16) for each child using a behavior checklist assessing trainer’s and the model’s 
behaviors. Specifically, the coder evaluated: A) the accuracy of completing the critical components of the 
training activities B) Trainer and model’s behaviors including instructions, prompts, positive 
reinforcement/praise, body movements (clarity, energy), voice, affect (smile and expressivity), scored on a 
5-point Likert score (1 indicates poor quality and 5 indicates high quality), and C) child’s compliance with 
the training activities, also scored on a 5-point Likert score.  
Testing Protocol 
Trained testers assessed the training-related changes in motor performance using standardized during each 
test visit. For the standardized tests, we used the Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) 
to assess children’s gross and fine motor proficiency (Bruininks et al., 2005), a 2-Minute Walk Test 
(2MWT) to assess their endurance (Bohannon et al., 2018), and the bilateral motor coordination subtests of 
the Sensory Integration and Praxis Tests (SIPT) to access their praxis performance (Ayres, 1988). Parents 
also completed the Developmental Coordination Disorder Questionnaire (DCD-Q; Schoemaker et al., 
2006) at each test visit, and both parents and the children filled out exit questionnaires to provide feedback 
on the feasibility, acceptability, and benefits of the interventions 
Standardized Tests 
Bruininks-Oseretsky Test of Motor Proficiency (BOT-2): BOT-2 is a valid and reliable assessment that 
targets 4 motor area composites with 8 subscales, including a) Fine Manual Control area, consisting of Fine 
Motor Precision, Fine Motor Integration subscales; b) Manual Coordination, consisting of Manual 
Dexterity and Upper-limb Coordination subscales; c) Body Coordination, consisting of Bilateral 
Coordination and Balance Subscales; and d) Strength and Agility, consisting of Running Speed and Agility 
and Strength subscales. The standard scores of the four motor areas were used to assess the training-related 
changes in motor performance. 

Two Minute Walk Test (2MWT)  
2MWT is a standardized measure of endurance. The child was asked to walk as fast as they can (without 
running) around 2 cones placed 50-feet apart for 2 minutes. The total distance the child walked in the 2-
minute period was used to assess the training-related changes in endurance. 
Sensory Integration and Praxis Tests (SIPT): We used the postural praxis and bilateral motor 
coordination subtests of the Sensory Integration and Praxis Tests (SIPT-PP and SIPT-BMC) to evaluate the 
praxis and sensory integration performance in children with ASD (Ayres, 1988). During the SIPT-PP, the 
tester sat across the children and performed 17 novel postures that involved fingers and upper/lower limb 
movements. An error was counted if the children posed with insufficient/exaggerated joint angles, incorrect 
joint and hand orientation, or using the wrong side of the body. Similarly, during the SIPT-BMC test, the 
tester sat across the children and performed 22 rhythmic action sequences involving hand-tapping, foot-
stomping, and foot-tapping. The children were asked to repeat the movement sequences back to the tester. 
An error was counted if the child paused in between the movement sequence, couldn’t pick up the rhythm, 
moved too fast or too slow, or failed to perform the right movement sequences. The number of errors the 
children made during the SIPT-PP and SIPT-BMC tests were used to monitor the training-related changes 
in praxis performance. 
Executive functioning (EF) Task 
During the EF task, we will use e-versions of variations of the Flanker test to assess the inhibition control 
and cognitive shifting elements of EF. There will be 2 conditions in the Flanker task, including: a) 
Congruent: Five fishes facing in the same direction (left or right) will be presented, and the child will be 
asked to raise the left or right index finger depending on the direction in which all the fishes are facing, b) 
Incongruent: the child will be presented with 4 fishes facing the same direction while the center fish will 
be facing in the opposite direction. Children will be asked to point to the left or right index finger depending 
on the direction of the center fish.  

Drumming Synchrony Task 
During the drumming synchrony task, children will be seated with a drum placed on the table in front of 
them. There will be 3 conditions: a) Music: the child will be asked to drum in order to match up to rhythmic 
beats played aloud in the background, b) Social: the child will sit face to face with an adult and be asked to 
match up to the movements of the adult. C) Virtual Social: the child will be seated facing a laptop screen 
and drum with a virtual partner through zoom conferencing. Both the child and the virtual partner will drum 
to rhythmic beats played aloud in the background. 
Parent reported motor outcome using the Developmental Coordination Disorder Questionnaire 
(DCD-Q) 
DCD-Q is a parent questionnaire to screen for developmental coordination disorder in children. 
Specifically, it screens for the child’s performance in three components, Control during movement (motor 
control while the child is moving or the target object is in motion, ex: catching, throwing), Fine 
motor/Handwriting (fine motor skills, ex: writing fast and legibly), and General coordination (motor 
planning/learning, ex: like sports and learn new skills).  
Children’s survey feedback 
Upon finishing all training sessions, each child answered 3 questions to provide feedback on their training 
experience. The questions include: A) Did you enjoy the activities we did? B) Did you find the activities 
easy or hard, C) Will you practice similar activities on your own or with mom/dad? Each question was 
answered with a picture-assisted 5-point Likert score (5- definitely yes/ very easy
; 4- yes/easy
; 3- 
maybe, neither too easy nor too hard
; 2- not so much/hard
; 1- not at all/very hard
).