Efficacy of Physical Activity for the Management of Stereotyped Behavior and Anxiety in Children with Autism Spectrum Disorder: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Childhood Autism Rating Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Double (Participant, Investigator)
Masking Description
Double
Eligibility Criteria
- Ages
- 8 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Who receives intervention i.e Physical Activity Intervention
Intervention: Physical Activity (Other)
Who would receive intervention after study completion
Intervention: Physical Activity (Other)
Outcomes
Primary Outcomes
Childhood Autism Rating Scale
Time Frame: 3 months
CARS consists of 15 items that assess various aspects of a child's behavior, including social interaction, communication, repetitive behaviors on the autism spectrum. CARS scored on a scale of 15-60, with higher scores indicating more severe autism. The Scoring following: 15-29.5: Non-autistic 30-36.5: Mild to moderate autism 37-60: Severe autism
Secondary Outcomes
No secondary outcomes reported
Investigators
Saba Rashid
Principal Investigator
Fatima Jinnah Women University