Efficacy of Physical Activity for the Management of Stereotyped Behavior and Anxiety in Children with Autism Spectrum Disorder
January 24, 2025 updated by: Saba Rashid, Fatima Jinnah Women University
Efficacy of Physical Activity for the Management of Stereotyped Behavior and Anxiety in Children with Autism Spectrum Disorder: a Randomized Controlled Trial
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan, 46000
- Vive Pricinipal ASEA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Who receives intervention i.e Physical Activity Intervention
|
Physical Activity is an 8-week practical intervention for managing the stereotyped behavior & anxiety.
Week 1: Introduction - Build engagement with the help of rapport building.
Learn & practice ball-tapping exercise with warm up & cool down relaxation exercise.
Week 2: Calmness- Practice jumping in trampoline exercise and learn balloon breathing exercise that give calmness.
Week 3: Focus enhancement-Learn skills of jumping exercise to increase focus and improve impulse.
Week 4: Strength, balance, and stress relief -explore the gym ball exercise in different directions that improves emotional regulation.
Week 5: self control - Learn strategies for specific jumping patterns that improves impulse control and focus in children with ASD.
Week 6: Reduce Stereotyped Behaviors - Learn complex trampoline exercises.
Week 7: Skill Reinforcement- Review exercises, increasing speed or direction changes.
Week 8: Integration -Encourage playful interaction to maintain engagement & consolidate skills.
|
|
Active Comparator: Who would receive intervention after study completion
|
Physical Activity is an 8-week practical intervention for managing the stereotyped behavior & anxiety.
Week 1: Introduction - Build engagement with the help of rapport building.
Learn & practice ball-tapping exercise with warm up & cool down relaxation exercise.
Week 2: Calmness- Practice jumping in trampoline exercise and learn balloon breathing exercise that give calmness.
Week 3: Focus enhancement-Learn skills of jumping exercise to increase focus and improve impulse.
Week 4: Strength, balance, and stress relief -explore the gym ball exercise in different directions that improves emotional regulation.
Week 5: self control - Learn strategies for specific jumping patterns that improves impulse control and focus in children with ASD.
Week 6: Reduce Stereotyped Behaviors - Learn complex trampoline exercises.
Week 7: Skill Reinforcement- Review exercises, increasing speed or direction changes.
Week 8: Integration -Encourage playful interaction to maintain engagement & consolidate skills.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 |
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Saba Rashid, MPhil Scholar, Fatima Jinnah Women University, Rawalpindi, Pakistan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 21, 2024
Primary Completion (Actual)
December 30, 2024
Study Completion (Actual)
December 30, 2024
Study Registration Dates
First Submitted
January 24, 2025
First Submitted That Met QC Criteria
January 24, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 24, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FJWU/EC/2024/97
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Due to ethical concerns the data will not be shared.
All research findings will be published in aggregate form maintaining participants anonymity.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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