Autism Spectrum Disorder (ASD)NCT06800001
Efficacy of Physical Activity for the Management of Stereotyped Behavior and Anxiety in Children With Autism Spectrum Disorder
A study testing Physical Activity in people with Autism Spectrum Disorder (ASD) and Stereotyped Behavior, run by Fatima Jinnah Women University at 1 site in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder (ASD), Stereotyped Behavior, Anxiety
- What is being tested?
- Physical Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 21 Aug 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Physical Activity
- Medical subject headings
- Autism Spectrum Disorder, Stereotyped Behavior, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Who receives intervention i.e Physical Activity Intervention | Experimental | Not described Receives: Other: Physical Activity |
| Who would receive intervention after study completion | Active comparator | Not described Receives: Other: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start21 Aug 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum Disorder (ASD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatima Jinnah Women University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saba Rashid, Fatima Jinnah Women University
- Investigators
- Saba Rashid, MPhil Scholar, Principal investigator, Fatima Jinnah Women University, Rawalpindi, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800001
- Sponsor's protocol ID
- FJWU/EC/2024/97
- Status last verified
- Jan 2025
- First submitted
- 24 Jan 2025
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to ethical concerns the data will not be shared. All research findings will be published in aggregate form maintaining participants anonymity.
Publications
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.
PubMed 31615098
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Physical Activity for the Management of Stereotyped Behavior and Anxiety in Children With Autism Spectrum Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06800001
- Acronym / sponsor ID
- FJWU/EC/2024/97
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fatima Jinnah Women UniversityUniversity, hospital or other
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Who receives intervention i.e Physical Activity Intervention | Experimental | Other: Physical Activity |
| Who would receive intervention after study completion | Active comparator | Other: Physical Activity |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ActivityPhysical 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. | Other | Who receives intervention i.e Physical Activity Intervention, Who would receive intervention after study completion |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Background: PubMed 31615098Ferreira 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Due to ethical concerns the data will not be shared. All research findings will be published in aggregate form maintaining participants anonymity.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saba Rashid, MPhil Scholar principal investigator
Fatima Jinnah Women University, Rawalpindi, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity in people with Autism Spectrum Disorder (ASD) and Stereotyped Behavior, run by Fatima Jinnah Women University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childhood Autism Rating Scale (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06800001, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.