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CTRI Number  CTRI/2021/02/031159 [Registered on: 09/02/2021] Trial Registered Prospectively
Last Modified On: 25/01/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Joint Attention Intervention for Parents of Children with Autism Spectrum Disorder 
Scientific Title of Study   Efficacy of a Parent-mediated Joint Attention Intervention for Children with Autism Spectrum Disorder 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Calida Frieda Pinto 
Designation  Research Associate 
Affiliation  Manipal College of Health Professions 
Address  Room no. 101 Department of Speech and Hearing Manipal College of Health Professions Manipal Academy of Higher Education Manipal-576104

Udupi
KARNATAKA
576104
India 
Phone  9986996848  
Fax    
Email  calida.pinto@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shivani Tiwari 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professions 
Address  Room no.409 Department of Speech and Hearing Manipal College of Health Professions Manipal Academy of Higher Education Manipal-576104

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  Manipal College of Health Professions 
Address  Room no.409 Department of Speech and Hearing Manipal College of Health Professions Manipal Academy of Higher Education Manipal-576104

Udupi
KARNATAKA
576104
India 
Phone  9986448718  
Fax    
Email  shivani.tiwari@manipal.edu  
 
Source of Monetary or Material Support  
Department of Speech and Hearing Manipal College of Health Professions, Manipal University and Kasturba Hospital, Manipal 
 
Primary Sponsor  
Name  Ms Calida Pinto 
Address  Department of Speech and Hearing Manipal College of Health Professions Manipal University 
Type of Sponsor  Other [Self] 
 
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 
Calida Pinto  Kasturba Hospital  Department of Speech and Hearing Room number 311, Third Floor CTC Building Kasturba Hospital Madhav Nagar, Manipal, Karnataka - 576104
Udupi
KARNATAKA 
9986996848

calida.pinto@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F840||Autistic disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Parent-mediated joint attention intervention  The present study will use a non-concurrent multiple baseline design across participants to examine the effectiveness of a parent-mediated joint attention training for CwASD. Parents of CwASD and their child with ASD who meet the eligibility criteria and who are willing to participate in the study will be recruited after taking a written informed consent. During the baseline phase, parent- child play sessions will be recorded for 10 minutes once a week without any coaching/feedback. The researcher will assess Responding Joint Attention in CwASD using Early Social Communication Scale. The parent training will also be carried out twice per week and each session will last for 1-hour duration. The time difference between the completion of baseline assessment and initiation of intervention will not exceed one week. The Joint Attention behaviours that will be used as a target during the intervention are focusing on faces (i.e., looking at any part of the face), and responding to joint attention. Additionally, strategies such as reinforcement, modelling, and prompting will be also introduced to the parents. Parent-mediated intervention will also be concurrently conducted by the parent in the child’s home daily for half an hour/day for 5 days/week. Parent training will involve a one-to-one session which will last for 1 hour/week including a 30-min PowerPoint presentation covering the information pertaining to the session. The parents will undergo training session every week where a live coaching model will be used to teach different activities and interaction styles for encouraging the child’s mastery of responding joint attention. The parents will also be instructed when and how to provide the needed support to encourage the child’s continued involvement in the activities. Prompting and reinforcement will be discussed in a detailed manner to all the parents. A parent-training manual will be provided to all parents for reference wherein all the JA activities will be mentioned that needs to be implemented at home. Likewise, the parent-training manual will comprise of all the strategies to promote joint attention. Modelling will be carried out of all the strategies with the parent and the child for a better understanding of the implementation of the strategies. Further, discussion regarding the activities will be carried out with parents and additional instances of potential strategy use across various routines.  
 
Inclusion Criteria  
Age From  22.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1) Parents of CwASD who are willing to participate in all assessment and intervention sessions on a regular basis
2) Parents who agree to implement therapy techniques at home for a minimum of half an hour/day
3) Parents who are fluent in English will be selected based on the Language Experience and Proficiency Questionnaire (LEAP-Q)
4) Parents will be selected based on the interview questions to assess factors like the home environment, socio-economic status, family type, time/nature of interaction with the child etc.
 
 
ExclusionCriteria 
Details  1) Parents who have known chronic psychiatric or locomotor disability
2) Parents with other child(ren) with disabilities
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1)Parent implementation of strategies
2)Responding joint attention in Children with Autism Spectrum Disorder 
Baseline
Weekly once during intervention
1-week follow-up post intervention
1-month follow up post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Language skills
Social skills
Cognitive skills 
Baseline
1-week follow up post intervention
1-month follow-up post intervention
 
 
Target Sample Size   Total Sample Size="9"
Sample Size from India="9" 
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 2 
Date of First Enrollment (India)   01/07/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   The researchers plan to publish results from the trial in peer reviewed journals 
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 (ASD) is a neurodevelopmental disorder characterized by core deficits in areas such as social interaction, non-verbal communication and 

restricted/repetitive behaviours (American Psychiatric Association, 2013). In Children with ASD (CwASD), decreased attention to the social world leads to deficits in 

social and cognitive development (Murray et al., 2008). Deficits in social communication includes impairment in using nonverbal communicative behaviours, deficits in 

establishing and managing appropriate relationships, and deficits in social emotion reciprocity (Soto, Gisserman-Kiss, & Carter, 2016). A large proportion of CwASD 

have limited pre-linguistic skills, such as eye-contact and joint attention (JA), which are foundational for the development of verbal language (Bakeman & Adamson, 1984).

Parent-mediated joint attention training

      Parents are children’s first communication partners, who also facilitate children’s intent to communicate. Despite varying in the way, they teach a  new 

language,  almost all parents build up their child’s speech and language skills. As children spend a lot of their time at home with parents, 

learning  skills  in  such  natural  environments  has been shown to be more effective, and facilitates generalization of learning. Hence, using a Parent Mediated 

Intervention  (PMI)  might  actually benefit the parents by  strengthening parental skills, and by providing greater opportunities for learning in CwASD. In fact, research 

over the last  decade  has  focussed on parent-implemented  interventions as a means of increasing social communication and reducing behavioural problems into the 

home   environment.  Researchers have also been  trying to  develop programs to teach joint attention skills to young children using various types of approaches. One 

such  approach is  facilitating joint attention in  CwASD using PMI. 

    A recent study in India suggests that despite having lack of resources in multiple settings, having parent’s involvement leads to noticeable changes during the 

behavioural intervention (Harshini & Preeti, 2017). A parent-child training program called Action for Autism (AFA) was adapted to the Indian context which was found 

to empower parents, enhance acceptance, knowledge and ability to guide their children. The findings of this study indicated that child’s functioning improved along with 

reduction in parental stress levels (Joseph & Muralidhar, 2018).  Despite the strong evidence about the positive effects of parent-mediated intervention for both 

parent  and child, there are no studies which has looked into parent- mediated joint attention intervention for CwASD in the Indian context. Effective parent-mediated 

interventions targeting joint attention for CwASD have been developed  in high-income settings, but there is a dearth of literature in developing countries like India.

Need for the study

Based on the intervention studies that have been implemented in the Indian context, there is a need to develop and train parents using a parent-mediated joint attention 


intervention to enhance joint attention skills in CwASD. Similarly, there is a need to explore if parent-mediated joint attention intervention can also facilitate language, 


social and cognitive abilities in CwASD. The sociocultural differences in parenting style and resources related to JA intervention also needs to be specific to the Indian 


context while evaluating a parent-mediated JA training in CwASD.


Aim 

To evaluate the efficacy of a parent-mediated joint attention intervention in terms of joint attention and language skills in CwASD

Objectives

1) To develop and validate a parent-mediated joint attention intervention manual

2)  To examine the influence of the parent-mediated joint attention intervention in children with ASD in terms of  

    • Parents’ implementation of strategies, 
    • RJA in CwASD
    • Child’s language (receptive and expressive), cognition and social skills

 
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