| CTRI Number |
CTRI/2024/03/063821 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
07/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A study to find out the effect of a Parent led activities on the change in the symptoms of a child with Autism Spectrum Disorder |
|
Scientific Title of Study
|
Effectiveness of a Parent-Mediated Intervention Program for Children with Autism
Spectrum Disorder
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pinky Chetia |
| Designation |
Ph.D. Scholar |
| Affiliation |
Lokapriya Gopinath Bordoloi Regional Institute of Mental Health |
| Address |
Department of Psychiatric Nursing, 3rd Floor, Academic Building, Gopinath Bordoloi Regional Institute of Mental Health,Tezpur
Department of Psychiatric Nursing, 3rd Floor, Academic Building, Gopinath Bordoloi Regional Institute of Mental Health,Tezpur
Sonitpur
ASSAM
784001
India |
| Phone |
8135980434 |
| Fax |
|
| Email |
pcpinky15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arunjyoti Baruah |
| Designation |
Professor and Head of Department, Department of Psychiatric Nursing , LGBRIMH |
| Affiliation |
Lokapriya Gopinath Bordoloi Regional Institute of Mental Health,Tezpur |
| Address |
Department of Psychiatric Nursing, 3rd Floor, Academic Building, Lokapriya Gopinath Bordoloi Regional Institute of Mental Health,Tezpur, Assam
Department of Psychiatric Nursing, 3rd Floor, Academic Building,Lokapriya Gopinath Bordoloi Regional Institute of Mental Health,Tezpur,Assam
Sonitpur
ASSAM
784001
India |
| Phone |
6901255064 |
| Fax |
|
| Email |
arunjyotibaruah@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyadarshee Abhishek |
| Designation |
Assistant Professor,Department of Clinical Psychology, LGBRIMH |
| Affiliation |
Lokapriya Gopinath Bordoloi Regional Institute of Mental Health |
| Address |
Department of Clinical Psychology, 5th Floor, Academic Building, Lokapriya Gopinath Bordoloi Regional Institute of Mental Health,Tezpur, Assam
Department of Clinical Psychology, 5th Floor, Academic Building, Lokapriya Gopinath Bordoloi Regional Institute of Mental Health,Tezpur, Assam
Sonitpur
ASSAM
784001
India |
| Phone |
9476916081 |
| Fax |
|
| Email |
psy.pabhishek@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lokapriya Gopinath Bordoloi Regional Institute of Mental Health |
|
|
Primary Sponsor
|
| Name |
Pinky Chetia |
| Address |
Staff Hostel, LGBRIMH,Tezpur, Assam-784001 |
| 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 |
| Dr Pinky Chetia |
Lokapriya Gopinath Regional Institute of Mental Health , Tezpur, Assam |
Department of Child and Adolescent Psychiatry Unit , Lokapriya Gopinath Regional Institute of Mental Health , Tezpur, Assam, Room no :9
Sonitpur
ASSAM |
8135980434
pcpinky15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee ,LGBRIMH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F840||Autistic disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Parent Mediated Intervention |
The parent mediated intervention program will consists of a prescribed set of naturalistic behavioral teaching strategies to facilitate child communication and pre-linguistic skills. Parent mediated Interventions will be delivered on one to one basis , over 16 sessions in two months period over 45-60 minutes of two session per week. Parents will be provided with homework assignments and list of activities to practice use of the intervention strategies and involvement with the child throughout their child’s daily routine and activities at home. Target behaviors or skills for parent-Mediated intervention emphasizes on capturing child attention, following child lead, improving joint attention and imitation, maintaining eye contact, turn taking, increasing child’s smiles and laughter during face-to-face social games, songs, and social exchanges and through other play based activities which will be embedded into the daily routines and natural environment of the child.
Total Duration of the intervention : 2 months |
| Comparator Agent |
Treatment As Usual Group |
Routine Behavioral intervention and other treatment carried out routinely on outpatient department basis |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
(a) Children had a diagnosis of ASD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) or ICD 10
(b) Children aged 3–6 years
(c) Parents aged 18–60 years
(e) Parents living with the diagnosed children during the intervention period
(f) Children’s who have not yet received any early behavioural interventions
|
|
| ExclusionCriteria |
| Details |
(a) Parents were diagnosed with other mental diseases that may affect their participation
(b) Parents had more than one child diagnosed with ASD
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.A low cost , culturally appropriate ,naturalistic behavioral intervention parent mediated module which will be tested for test its .
Impact on Pre-linguistic skills of the child
If the intervention is found out to be effective, the module will be translated to local language and made available for use in the public domain free of cost
2.Impact on Parental stress
3.Impact on Parental Self-efficacy |
Baseline , 8 weeks & 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.A low cost , culturally appropriate ,naturalistic
behavioral intervention parent mediated module
which will be tested for test its .
Impact on Pre-linguistic skills of the child
If the intervention is found out to be effective, the
module will be translated to local language & made available for use in the public domain free
of cost
2.Impact on Parental stress
3.Impact on Parental Self-efficacy |
Baseline , 8 weeks & 12 weeks |
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
15/03/2024 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Background : Autism Spectrum Disorder is a lifelong Neurodevelopmental disability characterized by impairment in social communication and interactions as well as the presence of restricted interest and stereotyped behavior. The prevalence of ASD in India is between 0.4-1.2% which roughly translates into approximately 1.7 million individuals with ASD in the country. The difficulties and challenges that accompany the child"s impairment can lead to considerable parenting stress and caregiving burden , further disrupts the parental psychological wellbeing and quality of life. In such a scenario for parent -mediated early intervention programs is amplified. Parent mediated intervention is a cost effective model to fill the existing gap . These are tecnique -focused intervention where the parent is the agent of change and the child is the direct beneficiary of the treatment . Parent mediated intervention can enhance social communication , adaptive behavior , cognition and language. Thus the researcher felt the need of conceptualizing the present study to highlight the implementation of a manualized evidenced - based parent intervention adapted to the cultural context of a clinical setting in India and test the effectiveness on child and parent outcome. The present study aims to develop a module on parent mediated intervention and to assess the effectiveness of the module on child and parent outcome
At the end of the study , the final results will be published at the indexed journal of UGC Care List as per Ph.D requirement |