Autism Spectrum Disorder (ASD)AAINCT06609122
Impact of AAI Dogs on Performance and Behavior of Children with Autism
A study testing Animal Assisted Intervention in people with Autism Spectrum Disorder (ASD), run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Autism Spectrum Disorder (ASD) is a lifelong neurodevelopmental disorder usually diagnosed in early childhood. Children with ASD exhibit social communication and interaction problems, which may cause deficits in social-emotional reciprocity, problems with developing, maintaining, and understanding relationships, and… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder (ASD)
- What is being tested?
- Animal Assisted Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Apr 2019to 31 Dec 2025
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- -Either gender aged 6 to 18 years old; have mild to moderate autism
Who cannot join
- -Who are not interested in the intervention and/or afraid of animals; who are allergic to animals; with severe mental/cognitive issues that might lead to injuries/ inconvenience to the animals and increase the likelihood of undersired events
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Special Schools in Hong Kong
Hong Kong, 0000
Dr Wilfred Wong, 85222554945
Hing-sang Wilfred Wong, p.hD. In Public Health
About this study
Official title: Impact of Animal-Assisted Intervention Dogs on the Performance Behaviors of Special Needs
Autism Spectrum Disorder (ASD) is a lifelong neurodevelopmental disorder usually diagnosed in early childhood. Children with ASD exhibit social communication and interaction problems, which may cause deficits in social-emotional reciprocity, problems with developing, maintaining, and understanding relationships, and abnormal nonverbal communicative behaviors such as impaired eye contact and body language. Some children with ASD have severe behavioral problems, such as stereotyped or repetitive motor movements, and extreme distress at small changes. ASD is a complex and individualized disorder, which creates challenges in treatment.
Animal-assisted education (AAE) programmes have been introduced for children with special needs in other countries such as the United States and Australia. PAALS (Palmetto Animal Assisted Life Services) in the United States have introduced the Pet a PAALS Dog programme, which assists stressed students at USC (University of South Carolina). Assistance Dogs Australia has provided an Educational Support Dog Echo to Kalinda Support School, for children with a wide range of disabilities. Existing literature indicate the benefit of animal-assisted therapy on physical, behavioral, and cognitive disabilities, especially in social and communication disorders. Formally trained human-dog teams in animal-assisted interventions (AAI) can play a unique role in social and communicative development that schools, and caregivers may not be able to provide. Interacting with animal-assisted intervention dogs can increase children with ASD\'s social interaction, communication, and effective connection. Dogs can also provide emotional support in stressful situations such as calming the child down when they have a tantrum. Moreover, animal-assisted therapy has shown to decrease stress levels, anxiety, and restrictive and repetitive behavior patterns. Dogs as pets can also bring significant improvements to caregivers of children with ASD and improve conflict management.
Based on a successful pilot trial in 2019 with 8 children showed that AAI program has a positive effect on the performance of children with ASD, The investigator proposed an observational study that tracks the effectiveness of an animal-assisted intervention programme in a local school for children with ASD and developmental disabilities.
Read the detailed description
This is an observational study that tracks the effectiveness of an AAI dog program in a local school for children with ASD and developmental disabilities.
- To evaluate the effectiveness of AAI on speech and language training, and quality of life in children with autism.
- To identify any problems of AAI carried out based on this protocol.
- To evaluate the cost of implementing AAI in Hong Kong.
For the pilot study, two to four students with mild to moderate autism which diagnosed by paediatrician will be selected through the following procedure. The pilot study of the animal-assisted intervention programme consists of two 15-min sessions per week, and a total of 8 sessions will be conducted at the chosen intervention centre from April 2019 to May 2019. The main study will be one year from April 2019 to April 2020. The intervention will occur in both individual and group settings. 2 to 4 students will be allocated to each individual session, and others will attend the group sessions. The project team will be made up of many professional including a qualified AAI dog, qualified AAI dog handler, occupational therapist, pediatrician, clinical psychologist, speech therapist, school teacher or school social worker. For the pilot study, two to four students with mild to moderate autism which diagnosed by paediatrician will be selected through the following procedure. The pilot study of the animal-assisted intervention programme consists of two 15-min sessions per week, and a total of 8 sessions will be conducted at the chosen intervention centre from April 2019 to May 2019. The main study will be one year from April 2019 to April 2020. The intervention will occur in both individual and group settings. 2 to 4 students will be allocated to each individual session, and others will attend the group sessions. The project team will be made up of many professional including a qualified AAI dog, qualified AAI dog handler, occupational therapist, pediatrician, clinical psychologist, speech therapist, school teacher or school social worker. The pediatrician, clinical psychologist and speech therapist will conduct a pre- and post-evaluation by assessing the child's condition before and after the programme. The speech therapist will supervise the therapy session in place of the occupational therapist if there is a speech impediment in the participant. The activities carried out during the intervention were previously planned by the project team members, who chose among the following per appropriateness for each session and depending on the interests of the subject: 1) sensorial and upper limb stimulation (brush, pet, and play fetch with the dog); 2) training on activities of daily living (give water and food to the dog) and gait (walking with the dog); 3) socialization and recreation (dog show; playing with the dog's supplies; dog drawing; agility courses-guide the dog through obstacles such as cones and ropes; dog clothes-form words that express feelings and attach them to the dog clothes with Velcro; stories about the dog-daily routine, origin). Before the start of the first session, the participants and their caregivers will complete the instruments described below with the help of a member of the research team trained for this purpose. At the end of the programme, the participants and their caregivers will fill out the same instruments again, and the physiological parameters will be re-measured. Outcome measuresments include problem identification, effectiveness of AAI, changes in quality of life, benefits and limitations of this intervention, and cost and feasibility of implementing the Animal Assisted Intervention Dog Traing Programme in Hong Kong which includes the cost of transport, and the cost of AAI dog and dog handler training.
- Conditions
- Autism Spectrum Disorder (ASD)
- Being tested
- Animal Assisted Intervention
- Keywords
- Animal Assisted Intervention, Animal Assisted Education, Animal Assisted Therapy, Therapy Dog, Animal Assisted Education Dog, Autism
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal Assisted InterventionOther
Animal-assisted intervention (AAI) is a therapeutic approach that involves animals as part of a treatment plan to improve physical, social, emotional, or cognitive functioning in individuals. Animals such as dogs, cats, horses, and even dolphins are commonly used in AAI due to their ability to provide comfort, companionship, and motivation.
AAI can take many forms, including animal-assisted therapy (AAT), where a trained therapy animal works with a licensed healthcare professional to achieve specific treatment goals. Animal-assisted activities (AAA) involve interactions with animals in a more casual and recreational setting, such as visits to hospitals or nursing homes to provide companionship and emotional support.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Students join the standard class at the same time slot |
| Intervention Group | Experimental | The teacher will work on the training goals with incorporation of the dog in the activity. For example, in the training of comprehension of commands, participant would be asked to take one item out of a few items, and then to pass to the dog. If correction of articulation errors is indicated (e.g. misarticulated /k/), training items would be picked under consideration of linkage to dogs. Words like '狗' /kɐu2/ and '教' /kau3/ would be used as stimuli during training. Receives: Other: Animal Assisted Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strengths and Difficulties Questionnaire (SDQ)
The Strengths and Difficulties Questionnaire (SDQ) is a common tool used to screen behavior in children and teenagers aged 3-16 years. It looks at emotional and behavioral challenges in five areas: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. Parents, teachers, or the young person themselves usually complete the 25-question survey. The responses help identify strengths and difficulties in different aspects. The SDQ is employed in clinics, research, and schools to spot children at risk of emotional or behavioral issues and track progress in intervention programs. Based on the scoring of SDQ, 80% of children scored normal, 10% borderline, and 10% abnormal.
Measured: within two weeks Pre-treatment and within two weeks Post-treatment
Pediatric Quality of Life Inventory (PedsQL) 4.0 Core
The Pediatric Quality of Life Inventory (PedsQL) 4.0 Core is a questionnaire used to assess the well-being of children and teenagers. It looks at their physical, emotional, social, and school functioning. Kids aged 2-18 years can fill it out, as well as their parents or caregivers. The results give a detailed picture of the child\'s quality of life. This tool is valuable in clinics, research, and schools to understand how health issues or treatments affect a child\'s overall happiness and health. The PedsQLTM 4.0 Generic Core Scales use a scale from 0-100, where higher scores mean better Health-Related Quality of Life. To calculate scores, reverse score the items on a 0-4 scale to a 0-100 scale: 0=100, 1=75, 2=50, 3=25, 4=0.
Measured: within two weeks Pre-treatment and within two weeks Post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 Apr 2019
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum Disorder (ASD)Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wilfred Hing-sang WONG, The University of Hong Kong
- Investigators
- Dr. Wilfred Wong, p.hD. In Public Health, Principal investigator, Department of Paediatrics & Adolescent Medicine, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609122
- Sponsor's protocol ID
- UW19-131
- Other IDs
- MHIFS, HKU/HA HKW IRB
- Acronym
- AAI
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
First MB. Diagnostic and statistical manual of mental disorders, 5th edition, and clinical utility. J Nerv Ment Dis. 2013 Sep;201(9):727-9. doi: 10.1097/NMD.0b013e3182a2168a. No abstract available.
PubMed 23995026Winkle M, Crowe TK, Hendrix I. Service dogs and people with physical disabilities partnerships: a systematic review. Occup Ther Int. 2012 Mar;19(1):54-66. doi: 10.1002/oti.323. Epub 2011 Aug 19.
PubMed 21858889Hall SS, Wright HF, Mills DS. What Factors Are Associated with Positive Effects of Dog Ownership in Families with Children with Autism Spectrum Disorder? The Development of the Lincoln Autism Pet Dog Impact Scale. PLoS One. 2016 Feb 19;11(2):e0149736. doi: 10.1371/journal.pone.0149736. eCollection 2016.
PubMed 26894820Wong WHS, Chen C, Tso A, So HK, Wong JPY, Tinsley H, Chung CHY, Luk RKW, Ip P. Dog-assisted therapy on Hong Kong children with autism spectrum disorder: an exploratory randomized controlled trial. Eur J Pediatr. 2026 Jan 9;185(1):64. doi: 10.1007/s00431-025-06720-6.
PubMed 41511681
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Animal-Assisted Intervention Dogs on the Performance Behaviors of Special Needs
- ClinicalTrials.gov ID
- NCT06609122
- Acronym / sponsor ID
- AAI / UW19-131
- Conditions
- Autism Spectrum Disorder (ASD)
- Keywords
- Animal Assisted Intervention, Animal Assisted Education, Animal Assisted Therapy, Therapy Dog, Animal Assisted Education Dog, Autism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Sep 2024 (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.
Autism Spectrum Disorder (ASD) is a lifelong neurodevelopmental disorder usually diagnosed in early childhood. Children with ASD exhibit social communication and interaction problems, which may cause deficits in social-emotional reciprocity, problems with developing, maintaining, and understanding relationships, and abnormal nonverbal communicative behaviors such as impaired eye contact and body language. Some children with ASD have severe behavioral problems, such as stereotyped or repetitive motor movements, and extreme distress at small changes. ASD is a complex and individualized disorder, which creates challenges in treatment.
Animal-assisted education (AAE) programmes have been introduced for children with special needs in other countries such as the United States and Australia. PAALS (Palmetto Animal Assisted Life Services) in the United States have introduced the Pet a PAALS Dog programme, which assists stressed students at USC (University of South Carolina). Assistance Dogs Australia has provided an Educational Support Dog Echo to Kalinda Support School, for children with a wide range of disabilities. Existing literature indicate the benefit of animal-assisted therapy on physical, behavioral, and cognitive disabilities, especially in social and communication disorders. Formally trained human-dog teams in animal-assisted interventions (AAI) can play a unique role in social and communicative development that schools, and caregivers may not be able to provide. Interacting with animal-assisted intervention dogs can increase children with ASD\'s social interaction, communication, and effective connection. Dogs can also provide emotional support in stressful situations such as calming the child down when they have a tantrum. Moreover, animal-assisted therapy has shown to decrease stress levels, anxiety, and restrictive and repetitive behavior patterns. Dogs as pets can also bring significant improvements to caregivers of children with ASD and improve conflict management.
Based on a successful pilot trial in 2019 with 8 children showed that AAI program has a positive effect on the performance of children with ASD, The investigator proposed an observational study that tracks the effectiveness of an animal-assisted intervention programme in a local school for children with ASD and developmental disabilities.
Detailed description
This is an observational study that tracks the effectiveness of an AAI dog program in a local school for children with ASD and developmental disabilities.
- To evaluate the effectiveness of AAI on speech and language training, and quality of life in children with autism.
- To identify any problems of AAI carried out based on this protocol.
- To evaluate the cost of implementing AAI in Hong Kong.
For the pilot study, two to four students with mild to moderate autism which diagnosed by paediatrician will be selected through the following procedure. The pilot study of the animal-assisted intervention programme consists of two 15-min sessions per week, and a total of 8 sessions will be conducted at the chosen intervention centre from April 2019 to May 2019. The main study will be one year from April 2019 to April 2020. The intervention will occur in both individual and group settings. 2 to 4 students will be allocated to each individual session, and others will attend the group sessions. The project team will be made up of many professional including a qualified AAI dog, qualified AAI dog handler, occupational therapist, pediatrician, clinical psychologist, speech therapist, school teacher or school social worker. For the pilot study, two to four students with mild to moderate autism which diagnosed by paediatrician will be selected through the following procedure. The pilot study of the animal-assisted intervention programme consists of two 15-min sessions per week, and a total of 8 sessions will be conducted at the chosen intervention centre from April 2019 to May 2019. The main study will be one year from April 2019 to April 2020. The intervention will occur in both individual and group settings. 2 to 4 students will be allocated to each individual session, and others will attend the group sessions. The project team will be made up of many professional including a qualified AAI dog, qualified AAI dog handler, occupational therapist, pediatrician, clinical psychologist, speech therapist, school teacher or school social worker. The pediatrician, clinical psychologist and speech therapist will conduct a pre- and post-evaluation by assessing the child's condition before and after the programme. The speech therapist will supervise the therapy session in place of the occupational therapist if there is a speech impediment in the participant. The activities carried out during the intervention were previously planned by the project team members, who chose among the following per appropriateness for each session and depending on the interests of the subject: 1) sensorial and upper limb stimulation (brush, pet, and play fetch with the dog); 2) training on activities of daily living (give water and food to the dog) and gait (walking with the dog); 3) socialization and recreation (dog show; playing with the dog's supplies; dog drawing; agility courses-guide the dog through obstacles such as cones and ropes; dog clothes-form words that express feelings and attach them to the dog clothes with Velcro; stories about the dog-daily routine, origin). Before the start of the first session, the participants and their caregivers will complete the instruments described below with the help of a member of the research team trained for this purpose. At the end of the programme, the participants and their caregivers will fill out the same instruments again, and the physiological parameters will be re-measured. Outcome measuresments include problem identification, effectiveness of AAI, changes in quality of life, benefits and limitations of this intervention, and cost and feasibility of implementing the Animal Assisted Intervention Dog Traing Programme in Hong Kong which includes the cost of transport, and the cost of AAI dog and dog handler training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Students join the standard class at the same time slot |
| Intervention Group | Experimental | Other: Animal Assisted InterventionThe teacher will work on the training goals with incorporation of the dog in the activity. For example, in the training of comprehension of commands, participant would be asked to take one item out of a few items, and then to pass to the dog. If correction of articulation errors is indicated (e.g. misarticulated /k/), training items would be picked under consideration of linkage to dogs. Words like '狗' /kɐu2/ and '教' /kau3/ would be used as stimuli during training. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- -Either gender aged 6 to 18 years old; have mild to moderate autism
Key exclusion criteria (1 listed)
- -Who are not interested in the intervention and/or afraid of animals; who are allergic to animals; with severe mental/cognitive issues that might lead to injuries/ inconvenience to the animals and increase the likelihood of undersired events
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 |
|---|---|---|
| Animal Assisted InterventionAnimal-assisted intervention (AAI) is a therapeutic approach that involves animals as part of a treatment plan to improve physical, social, emotional, or cognitive functioning in individuals. Animals such as dogs, cats, horses, and even dolphins are commonly used in AAI due to their ability to provide comfort, companionship, and motivation. AAI can take many forms, including animal-assisted therapy (AAT), where a trained therapy animal works with a licensed healthcare professional to achieve specific treatment goals. Animal-assisted activities (AAA) involve interactions with animals in a more casual and recreational setting, such as visits to hospitals or nursing homes to provide companionship and emotional support. | Other | Intervention Group |
Primary outcome
Strengths and Difficulties Questionnaire (SDQ)
Time frame: within two weeks Pre-treatment and within two weeks Post-treatment
The Strengths and Difficulties Questionnaire (SDQ) is a common tool used to screen behavior in children and teenagers aged 3-16 years. It looks at emotional and behavioral challenges in five areas: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. Parents, teachers, or the young person themselves usually complete the 25-question survey. The responses help identify strengths and difficulties in different aspects. The SDQ is employed in clinics, research, and schools to spot children at risk of emotional or behavioral issues and track progress in intervention programs. Based on the scoring of SDQ, 80% of children scored normal, 10% borderline, and 10% abnormal.
Pediatric Quality of Life Inventory (PedsQL) 4.0 Core
Time frame: within two weeks Pre-treatment and within two weeks Post-treatment
The Pediatric Quality of Life Inventory (PedsQL) 4.0 Core is a questionnaire used to assess the well-being of children and teenagers. It looks at their physical, emotional, social, and school functioning. Kids aged 2-18 years can fill it out, as well as their parents or caregivers. The results give a detailed picture of the child\'s quality of life. This tool is valuable in clinics, research, and schools to understand how health issues or treatments affect a child\'s overall happiness and health. The PedsQLTM 4.0 Generic Core Scales use a scale from 0-100, where higher scores mean better Health-Related Quality of Life. To calculate scores, reverse score the items on a 0-4 scale to a 0-100 scale: 0=100, 1=75, 2=50, 3=25, 4=0.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Background: PubMed 23995026First MB. Diagnostic and statistical manual of mental disorders, 5th edition, and clinical utility. J Nerv Ment Dis. 2013 Sep;201(9):727-9. doi: 10.1097/NMD.0b013e3182a2168a. No abstract available.
- Background: PubMed 21858889Winkle M, Crowe TK, Hendrix I. Service dogs and people with physical disabilities partnerships: a systematic review. Occup Ther Int. 2012 Mar;19(1):54-66. doi: 10.1002/oti.323. Epub 2011 Aug 19.
- Background: PubMed 26894820Hall SS, Wright HF, Mills DS. What Factors Are Associated with Positive Effects of Dog Ownership in Families with Children with Autism Spectrum Disorder? The Development of the Lincoln Autism Pet Dog Impact Scale. PLoS One. 2016 Feb 19;11(2):e0149736. doi: 10.1371/journal.pone.0149736. eCollection 2016.
- Derived from this study: PubMed 41511681Wong WHS, Chen C, Tso A, So HK, Wong JPY, Tinsley H, Chung CHY, Luk RKW, Ip P. Dog-assisted therapy on Hong Kong children with autism spectrum disorder: an exploratory randomized controlled trial. Eur J Pediatr. 2026 Jan 9;185(1):64. doi: 10.1007/s00431-025-06720-6.
- Individual participant dataSharing planned: Undecided
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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.
Dr. Wilfred Wong, p.hD. In Public Health principal investigator
Department of Paediatrics & Adolescent Medicine, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animal Assisted Intervention in people with Autism Spectrum Disorder (ASD), run by The University of Hong Kong at 1 site in Hong Kong.
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: status not confirmed, as of the sponsor's last update on 25 Sep 2024. 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 Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Wilfred Wong (85222554945, whswong@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strengths and Difficulties Questionnaire (SDQ) (time frame: within two weeks Pre-treatment and within two weeks Post-treatment). The study lists 2 primary outcomes in all. 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 NCT06609122, which also lists 4 linked publications.
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 25 Sep 2024.