| CTRI Number |
CTRI/2022/07/044152 [Registered on: 19/07/2022] Trial Registered Prospectively |
| Last Modified On: |
19/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Animal-Assisted Therapy] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Animal-Assisted Therapy for Children with Attention-Deficit/Hyperactivity Disorder |
|
Scientific Title of Study
|
Animal-Assisted Therapy for Social Competence of Children with Attention-Deficit/Hyperactivity Disorder |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hemangi Narayan Narvekar |
| Designation |
PhD (Psychology) Scholar |
| Affiliation |
CHRIST (Deemed to be University) |
| Address |
Room No. 790
Department of Psychology
Bangalore
KARNATAKA
560029
India |
| Phone |
9325517030 |
| Fax |
|
| Email |
narvekar.narayan@res.christuniversity.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarah Ghani |
| Designation |
Assistant Professor |
| Affiliation |
CHRIST (Deemed to be University) |
| Address |
Room No. 790
Department of Psychology
Bangalore
KARNATAKA
560029
India |
| Phone |
9325517030 |
| Fax |
|
| Email |
sarah.ghani@christuniversity.in |
|
Details of Contact Person
Public Query
|
| Name |
Hemangi Narayan Narvekar |
| Designation |
PhD (Psychology) Scholar |
| Affiliation |
CHRIST (Deemed to be University) |
| Address |
Room No. 790
Department of Psychology
Bangalore
KARNATAKA
560029
India |
| Phone |
9325517030 |
| Fax |
|
| Email |
narvekar.narayan@res.christuniversity.in |
|
|
Source of Monetary or Material Support
|
| CHRIST (Deemed to be University), Bangalore - 560029 |
| The DogSide, Bangalore - 560022 |
|
|
Primary Sponsor
|
| Name |
Hemangi Narayan Narvekar |
| Address |
Department of Psychology, CHRIST (Deemed to be University), Bangalore - Karnataka |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Hemangi Narayan Narvekar |
Petcart |
Survey No. 136, 18, Sarjapur Main road
Bangalore
KARNATAKA |
9325517030
narvekar.narayan@res.christuniversity.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| CHRIST University Institutional Review Board |
Approved |
| Petcartnest |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F90||Attention-deficit hyperactivity disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Animal-Assisted Therapy |
Structured intervention incorporating therapy animal for a duration of 4 weeks. Sessions would be for 45 to 60 minutes. |
| Comparator Agent |
Treatment as usual |
Usual treatment with no Animal-Assisted Therapy |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. ICD-10/DSM-V diagnosis of ADHD
2. IQ range of 50 and above
3. Mild severity
|
|
| ExclusionCriteria |
| Details |
1. Psychiatric conditions such as depression or anxiety
2. Fear/phobia of dogs
3. Allergies to dogs
4. History of cruelty to animals
5. Religious concerns about working with animals
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Social Competence as measured by VSMS |
Week 0, week 4, week 16 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Process evaluation of AAT |
Week 4 |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is proposed to explore the efficacy of Animal-Assisted Therapy on children with attention-deficit/hyperactivity disorder by utilizing a non-randomized clinical trial with two arms - parallel groups. The study hypothesizes that children will exhibit an increase in social competence after animal-assisted therapy. |