Intervention protocol for 6 â€“ 12 years children with Autism Spectrum Disorder

Not yet recruiting

Conditions: Autistic disorder,

Registration Number: CTRI/2023/05/052869

Lead Sponsor: Dr Monica Juneja

Brief Summary: Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by persistent deficits in social communication and social interaction and the presence of restricted, repetitive patterns of behavior, interests, or activities which impacts an individual across lifespan. Early diagnosis and timely initiation of evidence based therapies have shown to optimize developmental outcomes. Children with autism spectrum disorder above 6 years of age require a different skill set than toddlers and pre-schoolers to deal with the socializing element of life and to better adapt to the forthcoming academic demands. However, studies on interventions in children with ASD have largely focused on early intervention in toddlers and preschool age children and only few have evaluated the interventions for children with ASD beyond 6 years of life.

As established by research, children with ASD are educable and outcomes depend on timely institution of early interventions. As these children transition from toddler and preschool ages to childhood, they face differing challenges and difficulties, requiring a change in intervention strategies. Involvement of families and caregivers is vital for enabling continuation of therapies especially in a resource limited country like India, where there is a shortage of trained therapists. Since there is a paucity of studies evaluating interventions and their outcomes specifically for children aged 6-12 years, this study was planned. We intend to develop a caregiver mediated intervention protocol for children with Autism Spectrum Disorder of age 6-12 years and compare its efficacy with standard care.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 68

Inclusion Criteria

Children aged 6 to 12 years diagnosed with Autism Spectrum Disorder by DSM-V criteria having a mental age more than or equal to 3 years and functional speech of at least 3-word sentences with i)The primary caregiver willing to attend training sessions on specified dates, during the study period.
ii)Primary caregiver willing to spend at least 3 hours daily with their child for therapy related activities, during the study period.

Exclusion Criteria

1.Children with co-morbid neurodevelopmental disabilities, namely cerebral palsy, significant hearing impairment, significant visual impairment, poorly controlled seizures or neuro degenerative disorders.
2.Children with chronic systemic illnesses like chronic lung disease, chronic liver disease, congenital heart disease etc.
3.Children with syndromic ASD 4.Primary caregiver doesnâ€™t understand either Hindi or English.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference between mean change in SRS-2 score between the two groups	Baseline, and after 1 year of intervention

Secondary Outcome Measures

Name	Time	Method
1.Difference between mean change in CARS-2 score	2.Difference between mean change in VABS-3 score

Trial Locations

Locations (1): Centre of Excellence â€“ Early Intervention Centre
🇮🇳
Central, DELHI, India
Centre of Excellence â€“ Early Intervention Centre
🇮🇳Central, DELHI, India
Dr Monica Juneja
Principal investigator
9968604311
drmonicajuneja@gmail.com