Clinical trial NCT06800001: Efficacy of Physical Activity for the Management of Stereotyped Behavior and Anxiety in Children With Autism Spectrum Disorder
Official title: Efficacy of Physical Activity for the Management of Stereotyped Behavior and Anxiety in Children With Autism Spectrum Disorder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder (ASD)
Stereotyped Behavior
Anxiety
Lead sponsor: Fatima Jinnah Women University
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary purpose of the study is to investigate whether physical activity can significantly manage stereotyped behavior and anxiety in children diagnosed with Autism Spectrum Disorder (ASD). The study aims to contribute to the existing literature by providing robust evidence on the efficacy of Physical Activity intervention for ASD, which could inform clinical practices and improve treatment outcomes.

Detailed description: The current quantitative study will be carried out in two phases. A cross-sectional survey will assess the autism category (mild, moderate and severe), stereotyped behavior and anxiety in autistic children during the first phase. A randomized controlled trial (RCT) will be done during the second phase where children with Autism Spectrum Disorder who are identified with moderate category of autism, stereotyped behavior and anxiety will be categorized into two groups i.e. waitlist control group and intervention group through the process of randomization. Then physical activity intervention would be applied to participants in the intervention group. The control group is the waitlist control group so initially no intervention will be given to participants in the control group but the intervention will be given to the control group participants once the study is completed. The physical activity intervention would be implemented on participants using individual and in-person modes. The pre-and post-assessment will be done at Times 1 and 2 within and between control and interventional groups. After doing post assessment the difference between pre and post-assessment will be compared to explore the efficacy of physical activity intervention in children with Autism Spectrum Disorder.

Eligibility criteria: Inclusion Criteria:

Autistic children who are students of special education school. Only autistic children age 8 to 12 are part of the study. The participants who completed the informed consent will be part of the study. Participants who were showing symptoms of mild to moderate level of autistic symptoms as assessed by childhood autism rating scale. Participants should not have any physical or other mental health condition that would Prevent them from engaging in physical activity sessions safely were part of this study.

Exclusion Criteria:

Adults students are not part of the study. Autistic children who are not part of special education school. The participants who are severe autism category not part of the study. The participants who are under serious clinical condition will not be part of study.

Primary outcomes:
measure: Childhood Autism Rating Scale
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Vive Pricinipal ASEA
state: Punjab
Study officials:
affiliation: Fatima Jinnah Women University, Rawalpindi, Pakistan
name: Saba Rashid, MPhil Scholar
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferreira JP, Ghiarone T, Junior CRC, Furtado GE, Carvalho HM, Rodrigues AM, Toscano CVA. Effects of Physical Exercise on the Stereotyped Behavior of Children with Autism Spectrum Disorders. Medicina (Kaunas). 2019 Oct 14;55(10):685. doi: 10.3390/medicina55100685.