Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06609122
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Impact of AAI Dogs on Performance and Behavior of Children with Autism
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of Animal-Assisted Intervention Dogs on the Performance Behaviors of Special Needs
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AAI
Brief 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 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 ASDampampampampamp39s 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
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 ASDampampampampamp39s 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
1 To evaluate the effectiveness of AAI on speech and language training and quality of life in children with autism
2 To identify any problems of AAI carried out based on this protocol
3 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 childs 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 dogs 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
1 To evaluate the effectiveness of AAI on speech and language training and quality of life in children with autism
2 To identify any problems of AAI carried out based on this protocol
3 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 childs 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 dogs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None