| CTRI Number |
CTRI/2017/11/010337 [Registered on: 02/11/2017] Trial Registered Prospectively |
| Last Modified On: |
01/11/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing behavior of parents of children with autism in Kannada. |
|
Scientific Title of Study
|
Adaptation and Validation of Parental Behavioral Scale-short version for parents of children with Autism in Kannada |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gayathri K S |
| Designation |
PG Student |
| Affiliation |
School of allied health sciences |
| Address |
Department of speech and hearing
School of allied health sciences
Manipal University
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8129369155 |
| Fax |
|
| Email |
gayuzzgayu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivani Tiwari |
| Designation |
Associate professor |
| Affiliation |
School of allied health sciences |
| Address |
Department of speech and hearing
School of allied health science
Manipal University
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9986448718 |
| Fax |
|
| Email |
shivani.tiwari@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Tiwari |
| Designation |
Associate professor |
| Affiliation |
School of allied health sciences |
| Address |
Department of speech and hearing
School of allied health science
Manipal University
Manipal
KARNATAKA
576104
India |
| Phone |
9986448718 |
| Fax |
|
| Email |
shivani.tiwari@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Speech and Hearing, School of Allied Health Sciences,Manipal |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [no sponsor for the study] |
|
|
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 |
| Gayathri K S |
Kasturba medical college, manipal |
Department of speech and hearing
Room no.28
School of allied health sciences
Kasturba Medical College
Manipal University
Manipal
Udupi
KARNATAKA |
8129369155
gayuzzgayu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Hospital, Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Parents of children with Autism |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Children between 4 to 16 years with a formal diagnosis of ASD as per DSM-V will be included in the study.
Age range of parents of the children with autism will fall approximately between 25 to 45 years.
Marital status (both parents, divorced, widow/widower) and education level will be taken into consideration for the study.
|
|
| ExclusionCriteria |
| Details |
Children with intellectual disability (IQ<70) will be excluded from this study.
Illiterate parents who are not able to read and write (both of them) will be excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To translate, adapt and validate Parental Behavior Scale- Short version in parents of children with autism in Kannada. |
08/11/2017 to 07/03/2018 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To translate, adapt and validate Parental Behavior Scale- Short version in parents of children with autism in Kannada. |
08/11/2017 to 07/03/2018 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
10/11/2017 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Bromley, J., Hare, D. J., Davison, K., & Emerson, E. (2004). Mothers supporting children with autistic spectrum disorders: Social support, mental health status and satisfaction with services. Autism, 8, 409-423.
Dabrowska, A., & Pisula, E. (2010). Parenting stress and coping styles in mothers and fathers of pre-school children with autism and Down syndrome. Journal of Intellectual Disability Research, 54, 266-280.
Davis, N. O., & Carter, A. S. (2008). Parenting stress in mothers and fathers of toddlers with autism spectrum disorders: Associations with child characteristics. Journal of Autism and Developmental Disorders, 38, 1278-1291.
Duarte, C. S., Bordin, I. A., Yazigi, L., & Mooney, J. (2005). Factors associated with stress in mothers of children with autism. Autism, 9, 416-427.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Autism is defined as a complex neurobehavioral condition that includes impairments in social interaction and developmental language and communication skills along with repetitive behaviors and has difficulty understanding what other people think and feel. A research on parental behavior assessment concluded that parents of a child with ASD experience high levels of parenting stress and psychological distress (Bromley et al.,2004; Dabrowska & Pisula, 2010; Davis & Carter, 2008; Duarte et al., 2005; Estes et al., 2009; Montes & Halterman, 2007). Meirsschaut, Roeyers, and Warreyn (2010) investigated mothers’ perceptions of the impact of having a child with ASD on both personal and family life and the study concluded that inorder to maximize the intervention outcome, the parenting experiences should be considered and should become aware of parental feelings. Currently, there is only little research focusing on concrete parenting behavior in families of a child with ASD. In particular, there is no such study done in the Indian context and hence this becomes the need for the study. |