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Development of an early screening instrument for Autism Spectrum Disorder.

Development and validation of an early screening instrument for Autism Spectrum Disorder.

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/04/041686
Enrollment
1195
Registered
2022-04-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F840- Autistic disorder

Interventions

Intervention1: NIL: NIL Intervention2: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

C A Ashitha Sreelakshmi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Babies coming for immunization or general check-up at the study centre. 2. Babies with normal and atypical speech-language/motor development. 3. Babies with relevant family, birth, and medical history.

Exclusion criteria

Exclusion criteria: 1. Babies of parents who do not consent to participate in the study. 2. Babies with obvious hearing & vision impairment and cerebral palsy.

Design outcomes

Primary

MeasureTime frame
Initial assessment: Results from the assessment using the new screening tool developed. First follow up assessment: Results from assessment using M-CHAT-R/F (Modified Checklist for Autism in Toddlers - Revised with Follow Up). Second follow up assessment: Results from assessment using DSM 5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition).Timepoint: Between 9 to 12 months (Initial assessment), 18 months (First follow up assessment), 24 months (Second follow up assessment).

Secondary

MeasureTime frame
Results from Modified Checklist for Autism in Toddlers, Revised with Follow-Up(M-CHAT-R/F)Timepoint: 18 months (1 1/2 years);Results from Diagnostic and Statistical Manual of Mental Disorders , 5th Edition (DSM-5)Timepoint: 24 months (2 years)

Countries

India

Contacts

Public ContactDr Veena K D

Manipal College of Health Professions, Manipal Academy of Higher Education

r.veena@manipal.edu9448824346

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026