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CTRI Number  CTRI/2024/10/075490 [Registered on: 18/10/2024] Trial Registered Prospectively
Last Modified On: 29/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Role of animals in helping a child with Autism spectrum disorder - A case study 
Scientific Title of Study   Impact of animal assisted therapy on a child with Autism spectrum disorder- A case study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  aditi pramod deore 
Designation  PG student 
Affiliation  Dr.A.P.J Abdul Kalam College of Physiotherapy 
Address  Pravara Institute of Medical Sciences, Dr. A.P.J Abdul Kalam College of Physiotherapy ,Department of pediatric physiotherapy, Loni, 413736

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  09075755334  
Fax    
Email  aditideore01@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tejas Borkar PT 
Designation  Associate Professor 
Affiliation  Dr.A.P.J Abdul Kalam College of Physiotherapy 
Address  504, Department of Paediatric physiotherapy, Dr.A.P.J Abdul Kalam College of Physiotherapy ,Pravara Institute of Medical Sciences, Loni, 413736 Ahmadnagar MAHARASHTRA 413736 India

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  09371271752  
Fax    
Email  tejasborkar57@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Tejas Borkar PT 
Designation  Associate Professor 
Affiliation  Dr.A.P.J Abdul Kalam College of Physiotherapy 
Address  504, Department of Paediatric physiotherapy, Dr.A.P.J Abdul Kalam College of Physiotherapy ,Pravara Institute of Medical Sciences, Loni, 413736 Ahmadnagar MAHARASHTRA 413736 India


MAHARASHTRA
413736
India 
Phone  09371271752  
Fax    
Email  tejasborkar57@gmail.com  
 
Source of Monetary or Material Support  
Dr. APJ Abdul Kalam College of Physiotherapy, Pravara Institute of Medical Sciences, Loni,413736 
 
Primary Sponsor  
Name  Dr. A.P.J Abdul Kalam College of Physiotherapy, PIMS , Loni 
Address  Pravara Institute of Medical Sciences, Dr. A.P.J Abdul Kalam College of Physiotherapy , Loni, 413736 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tejas Borkar PT  Dr. A.P.J Abdul Kalam College of Physiotherapy  Pravara Institute of Medical Sciences, Dr. A.P.J Abdul Kalam College of Physiotherapy, Department of pediatric physiotherapy, room no 504 , Loni, 413736
Ahmadnagar
MAHARASHTRA 
9371271752

tejasborkar57@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F90-F98||Behavioral and emotional disorders with onset usually occurring in childhood and adolescence, (2) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Animal assissted intervention  Animal Assisted Therapy for child with Autism Spectrum Disorder for each animal therapy session for 45 mins. 3 animals that is cow , dog, goat will be used to assess the interaction of the child with each animal.Total 3 weeks of intervention will be given. The response will be recorded on Indian scale for assessment of autism on the basis of behaviour during the session. The difference in the social behaviour and interaction will be desbribed in the results 
Comparator Agent  None  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  7.00 Year(s)
Gender  Male 
Details  Child prediagnosed with Autism Spectrum Disorder
Participant whose parent are willing to give written informed consent
 
 
ExclusionCriteria 
Details  Child with other neurological conditions
Child with history of allergy to animals
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Indian scale for assessment of autism

Pediatric balance scale 
pre and post intervention 
 
Secondary Outcome     
Target Sample Size   Total Sample Size="1"
Sample Size from India="1" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/10/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

PRAVARA INSTITUTE OF MEDICAL SCIENCES LONI, 413 736.

Annexure – II

PROFORMA FOR REGISTRATION OF SUBJECTS

FOR DISSERTATION

 

 

1

 

Name of the Candidate

And Address

Miss. Aditi Pramod Deore.

 Dr. APJ Abdul Kalam College of Physiotherapy

Pravara Institute of Medical Sciences

Loni – 413736 Maharashtra.

 

2

 

Name of the Institution

 

Dr. APJ Abdul Kalam College of Physiotherapy,

Pravara Institute of Medical Sciences

Loni – 413736 Maharashtra.

 

 

3  

 

Course of Study and

Subject

 

MASTER OF PEDIATRIC PHYSIOTHERAPY

 

 

4

 

Date of Admission to the

Course

 

 

4 SEPTEMBER 2023

 

5

 

 

 

Title of the Topic

 

IMPACT OF ANIMAL-ASSISTED THERAPY ON A CHILD WITH AUTISM SPECTRUM DISORDER - A CASE STUDY

6

BRIEF RESUME OF THE INTENDED WORK:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

INTRODUCTION:

 

A neurological congenital condition known as autism spectrum disorder (ASD) can cause mild to severe difficulties with regulation, social interaction, communication, and repetitive or restrictive behaviors. (1) Autism Spectrum Disorder is a heterogeneous disorder, diagnosed on the basis of behavioural symptoms during the second year of life or later. High-risk infant sibling’s studies have demonstrated that the defining behavioural features of ASD emerge during the latter part of the first and second years of life. Because ASD is behaviourally and not biologically defined, a formal diagnosis of ASD before three years of age remains challenging and a diagnosis until the preschool years or later is difficult. Milder forms of ASD are particularly difficult to detect early, in part because a broad range of neurodevelopmental symptoms are common to several diagnoses, including ASD. Even in cases of diagnostic uncertainty, reliable biomarkers that detect emerging ASD symptoms might be useful for developing appropriate early interventions (2). Autism spectrum disorders includes Autistic disorder (autism) (both low and high functioning), Asperger’s syndrome, Rett disorder, Pervasive developmental disorder–not otherwise Specified (PDD-NOS), Childhood disintegrative disorder (3)

The prevalence of ASD has increased in a highly populated and demographically “young” country like India (4). Today, ASDs have a prevalence of 62/10,000 globally, 1 in every 150 children in the U.S (5) .In northwest India, the prevalence rate is 0.09/100 while it is 9.4% in Pondicherry, South India (6)  The prevalence of ASD in Belagavi was 0.19% in 16-30 months children belonging to upper‑middle SES (5)

Animal-Assisted Therapy (AAT) is characterized by a professional therapist incorporating an animal in an intervention to achieve predetermined goals(7 ) It has been suggested that individuals benefit from the therapeutic qualities of the animal as intuitive, nonjudgmental, non-verbal communicators (1). Reviews of the literature have found preliminary support for AAT for children with Autism Spectrum Disorder (ASD) and positive outcomes in symptom reduction have been reported (8) Preliminary research findings suggest that animal assisted interventions involving either dogs, horses or llamas, may promote positive verbal and non-verbal social behavior in children and adolescents with ASD, while simultaneously lessening the expression of isolating and aggressive behavior(9) Overall, this evidence suggests that interacting with pets, owning a pet as well as animal-based humane education programs have a great potentiality for counteracting child behavioral problems (e.g. learning disabilities, aggressiveness and attention deficit) and for aiding social integration, although further research and long-term studies are required to confirm that animals are positive casual agents in children social and cognitive development(10)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Need for the study:

Autism Spectrum Disorder (ASD) is a complex neurodevelopmental disorder characterized by challenges in social communication and repetitive behaviors. While traditional therapeutic interventions have been effective to varying degrees, there is a growing interest in exploring alternative and complementary approaches to address the unique needs of individuals with ASD. One such promising avenue is animal-assisted therapy, which involves the incorporation of animals into therapeutic interventions to enhance emotional, social, and cognitive functioning.

The existing literature on animal-assisted therapy for individuals with ASD primarily focuses on the general benefits of interaction with animals. However, there is a significant gap in research that specifically investigates the differential effects of therapy involving various types of animals on a single individual with ASD. This dissertation aims to bridge this gap by conducting a comprehensive case study exploring the impact of animal therapy using different animals on a child diagnosed with ASD. Understanding the influence of various animals in the therapeutic process is essential for tailoring interventions to meet the specific needs of each child with ASD. The heterogeneous nature of the disorder necessitates personalized approaches that consider individual preferences, sensitivities, and responses. This research seeks to provide valuable insights into the potential benefits of animal therapy and contribute to the development of more targeted and effective interventions for children with ASD.

 

 

 

 

 

 

 

Research Question?                

What is the impact of animal therapy, on the social, emotional, and cognitive well-being of child with Autism Spectrum Disorder?

 

6.2 Aim and Objectives of the study:

Aim:

To investigate the impact of animal-assisted therapy, involving various animals, on the social, emotional, and cognitive well-being of a child with Autism Spectrum Disorder (ASD)

 

Objective:

 

1.     To examine the specific therapeutic effects of interactions with different animals on the social communication skills of the child with ASD.

2.     To assess the emotional responses and regulation of the child when engaging in animal-assisted therapy with various animals.

3.     To explore the cognitive benefits, including attention, focus, and problem-solving skills, derived from interactions with different animals during therapy sessions.

4.     To identify individual preferences, sensitivities, and unique responses that may influence the outcomes of animal-assisted therapy for the child with ASD.

Research Question?                

What is the impact of animal therapy, on the social, emotional, and cognitive well-being of child with Autism Spectrum Disorder?

 

6.2 Aim and Objectives of the study:

Aim:

To investigate the impact of animal-assisted therapy, involving various animals, on the social, emotional, and cognitive well-being of a child with Autism Spectrum Disorder (ASD)

 

Objective:

 

1.     To examine the specific therapeutic effects of interactions with different animals on the social communication skills of the child with ASD.

2.     To assess the emotional responses and regulation of the child when engaging in animal-assisted therapy with various animals.

3.     To explore the cognitive benefits, including attention, focus, and problem-solving skills, derived from interactions with different animals during therapy sessions.

4.     To identify individual preferences, sensitivities, and unique responses that may influence the outcomes of animal-assisted therapy for the child with ASD.

 

    

a.     REVIEW OF LITERATURE:

1.  Raina SK, Chander V et al (2018) conducted a study titled ‘Prevalence of autism spectrum disorder among rural, urban, and tribal children (1–10 years of age).’ The study aimed at finding prevalence of autism spectrum disorder which concluded that 43 children out of a total of 28,070 children in rural, urban, and tribal area in the age group of 1–10 years were diagnosed as cases of ASD yielding a prevalence of 0.15% (95% confidence interval [CI] =0.15–0.25). Logistic regression analysis showed a two times significantly higher risk of diagnosing ASD in rural area as compared to tribal (odds ratio [OR]; 95% CI = 2.17 [1.04–4.52], P = 0.04). Male sex and upper socioeconomic group of head of family/father had a higher risk of getting diagnosed as autism as compared to lower socioeconomic group (OR; 95% CI ‑ 3.23; 0.24–44.28, P = 0.38).

2.     Kodak T, Bergmann S. (2020) conducted a study titled ‘Autism Spectrum Disorder: Characteristics, Associated Behaviors, and Early Intervention’ in which Interventions based on applied behavior analysis have the most empirical support; several strategies to teach social skills, communication, and adaptive skills are discussed.

3.     Maeve Doyle London1, Lynette Mackenzie et al (2020) conducted a study that explored parent perspectives of the impact of five Animal Assisted Therapy sessions involving trained dogs with their children with ASD. Seventeen parents reported that the presence of the dogs facilitated their children’s engagement, enjoyment, and motivation. Parents also reported that this contributed to gains in the child’s communication with others and the dog (n=11, 64.7%), behavioral regulation (n=12, 70.6%), and community participation (n=14, 82.3%). These findings indicated that parents supported the use of AAT and that dogs facilitated therapeutic gains.

4.     François Martin Jennifer Farnum (2002) evaluated the effects of supervised interaction with dogs on children with Pervasive Developmental Disorders (PDD), examining both behavioral and verbal dimensions. This interaction with dogs was compared to interactions in two other conditions: (a) a ball and (b) a stuffed dog. This study concluded that interaction with dogs may have a positive effect on the behaviors of children with PDD.

5.     Francesca Cirulli, Marta Borgi et al (2011) conducted a review in which they analyzed the evidence underlying the potential influence of interaction with animals, especially dogs, for human health and concluded that animals tend to focus and absorb people’s attention in non-threatening ways and by and large, domesticated animals should be used as they are those that have been selected for their ability to interact socially (and emotionally) with humans.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

MATERIAL AND METHODOLOGY:

Source of Data:  Pediatric Physiotherapy OPD, Dr. A.P.J. Abdul Kalam college of Physiotherapy.

Method of collection of data: (Including sampling procedure if any)

Study Design: Case Study.

Study Setting- Loni, Ahmednagar.

Sample size:1

Participant: Autism Spectrum Disorder.

 

 

 

Material to be used:

1. Consent form

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SELECTION CRITERIA:

Inclusion criteria:

Child prediagnosed with Autism Spectrum Disorder

Participant whose parent are willing to give written informed consent

 

Exclusion criteria:

Child with other neurological conditions

Child with history of allergy to animals

 

Outcome Measures:

 

1.     Indian Scale for Assessment of Autism (ISAA) (r = 0.83)

2. Pediatric Balance Scale( r=0.99)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Procedure

-The caregiver of the subject will be explained about the study and written inform consent form will be signed by them.

Ethical approval from IEC

 

Selection of Participant according to Inclusion and Exclusion criteria

 

 

 

 

 


 

Assessment of social responsiveness and gross motor difficulties of child using Indian scale for assessment of autism and pediatric balance scale at the end of 45 mins of sessions

Results and Analysis will be Done.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


Intervention               

Animal Assisted Therapy for child with Autism Spectrum Disorder for each animal therapy session for 45 mins with various animals.

 

 

Statistical Analysis:

7.3 Does the study require any interventions or investigations to be conducted on patients or other human or animals? If so, please describe briefly?

     NA

 7.4 Has ethical clearance been obtained from your institution in case of 7.3?

 Referred for ethical clearance

   NA

 

 

 

 

 

 

 

 

 

 

 

 

 

 

REFERENCES:

1.    Grandin, T., Fine, A., & Bowers, C. (2010). The roles of animals for individuals with Autism Spectrum Disorder. In A. Fine (Ed.), Handbook on animal-assisted therapy (3rd ed., pp. 247–264). Boston: Elsevier Inc.

2.     Bosl WJ, Tager-Flusberg H, Nelson CA. EEG analytics for early detection of autism spectrum disorder: a data-driven approach. Scientific reports. 2018 May 1;8(1):1-20.

3.     Carol Turkington, Ruth Anan, Ph.D. The Encyclopedia of Autism Spectrum Disorder,2007;

4.     Dalwai SH, Modak DK, Bondre AP, Gajria D. Analysis of tools for diagnosing autism spectrum disorder in the Indian context. Acad J Pediatr Neonatol 2016;1:555‑62

5.     Metgud DC, Paulose S. Screening of children for autism spectrum disorders using Modified Checklist for Autism Spectrum Disorders (MCHAT) in toddlers in the age group 16-30 months: An observational study. Indian Journal of Physical Therapy and Research. 2019 Jul 1;1(2):110.

6.     Raina SK, Chander V, Bhardwaj AK, Kumar D, Sharma S, Kashyap V, et al. Prevalence of autism spectrum disorder among rural, urban, and tribal children (1‑10 years of age). J Neurosci Rural Pract 2017;8:368‑74.

7.     Friedmann, E., Son, H., & Saleem, M. (2010). The animal−human bond: Health and wellness. In A. Fine (Ed.), Handbook on animalassisted therapy (3rd ed., pp. 85–100). Boston: Elsevier Inc

8.     Berry, A., Borgi, M., Francia, N., Alleva, E., & Cirulli, F. (2013). Use of assistance and therapy dogs for children with Autism Spectrum Disorders: A critical review of the current evidence. Journal of Alternative and Complementary Medicine, 19(2), 73–80.

9.     O’Haire, M. (2013). Animal-assisted intervention for Autism Spectrum Disorder: A systematic literature review. Journal of Autism and Developmental Disorders, 43(7), 1606–1622.

10.  Prothmann A, Albrecht K, Dietrich S, Hornfeck U, Stieber S, Ettrich C. Analysis of child-dog play behavior in child psychiatry. Anthrozoös 2005;18:43-58.

 

 


 
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