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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Pakistan
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Who receives intervention i.e Physical Activity Intervention
Other: 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.
Active Comparator: Who would receive intervention after study completion
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fatima Jinnah Women University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 21, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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