Efficacy of Physical Activity for the Management of Stereotyped Behavior and Anxiety in Children With Autism Spectrum Disorder

NCT06800001 | Completed DMC

• 1 other identifier: FJWU/EC/2024/97
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder (ASD); Stereotyped Behavior; Anxiety

Outcome Measures

Primary Outcomes (1)

• Childhood Autism Rating Scale

  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

Study Arms (2)

Who receives intervention i.e Physical Activity Intervention

EXPERIMENTAL

Other: Physical Activity

Who would receive intervention after study completion

ACTIVE COMPARATOR

Other: Physical Activity

Interventions

Physical Activity OTHER

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.

Who receives intervention i.e Physical Activity Intervention; Who would receive intervention after study completion

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fatima Jinnah Women University: lead

Study Sites (1)

Vive Pricinipal ASEA

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 31615098 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Autism Spectrum Disorder; Stereotyped Behavior; Anxiety Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Saba Rashid, MPhil Scholar

  Fatima Jinnah Women University, Rawalpindi, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 29, 2025
• Study Start: August 21, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)