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

NCT ID: NCT06800001

Last Updated: 2025-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-21

Study Completion Date

2024-12-30

Brief Summary

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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

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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.

Conditions

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Autism Spectrum Disorder (ASD) Stereotyped Behavior Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators
Double

Study Groups

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Who receives intervention i.e Physical Activity Intervention

Group Type EXPERIMENTAL

Physical Activity

Intervention Type 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 would receive intervention after study completion

Group Type ACTIVE_COMPARATOR

Physical Activity

Intervention Type 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.

Interventions

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Physical Activity

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fatima Jinnah Women University

OTHER

Sponsor Role lead

Responsible Party

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Saba Rashid

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Saba Rashid, MPhil Scholar

Role: PRINCIPAL_INVESTIGATOR

Fatima Jinnah Women University, Rawalpindi, Pakistan

Locations

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Vive Pricinipal ASEA

Rawalpindi, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 31615098 (View on PubMed)

Related Links

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Other Identifiers

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FJWU/EC/2024/97

Identifier Type: -

Identifier Source: org_study_id

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