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A study to understand role of early intervention, delivered by parents, to children who may later develop autism or other related conditions.

Parent Mediated Early Intervention for Baby Siblings of Children with Autism Spectrum Disorder who are at High Familial Risk to Develop Autism and Related Disorders

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/043681
Enrollment
30
Registered
2022-07-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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: Parent Mediated Early Intervention for Baby Siblings of Children with Autism Spectrum Disorder: This is a behavioral intervention study. The intervention group will receive parent media

Sponsors

Dr Shoba Sreenath Meera
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Subjects with an older sibling fulfilling criteria for ASD based on Social Communication Questionnaire and/or clinical best estimate diagnosis-DSM 5 guidelines Subjects with atypicalities identified by age appropriate assessments (for example First Year Inventory), or parental concerns or parents wishing to enroll their infant in the intervention Subjects between the ages of 9 to 18 months at least one parent willing to participate in the parent mediate intervention Subjects whose primary language environments are Kannada, Hindi, English Parents who have access to basic technology including a device ( for example laptop or smart phone) and adequate internet connectivity ( wifi, 4G mobile internet) to support video conferencing platforms like zoom.

Exclusion criteria

Exclusion criteria: Subjects with significant medical conditions known to affect brain development like Downs syndrome Diagnosis of sensory impairment like hearing loss Less than 2500 grams of birth weight Perinatal birth injury secondary to birth complications like asphyxia First degree relative with psychosis, schizophrenia or bipolar disorder based on family interview for genetic studies.

Design outcomes

Primary

MeasureTime frame
Score of Sensitive Responsiveness global rating scale - Manchester Assessment for Caregiver-Infant Interaction (MACI-Infant) Timepoint: T1-Baseline T2-12 Weeks after intervention

Secondary

MeasureTime frame
(1) Scores of Caregiver Non-directiveness, Infant attentiveness, Infant positive affect, Mutuality, Engagement intensity global rating scales- Manchester Assessment of Caregiver-Infant Interaction (MACI-Infant). (2)Social Composite Standard Scores - Communication and Symbolic Behavior Scales-Caregiver Questionnaire (CSBS-CGQ) (3) Receptive and Expressive Vocabulary count, early gesture count- MacArthur-Bates Communicative Development Inventory (MCDI) (4) Adaptive Behavior Composite standard scores, Communication standard scores, Socialization standard scores -Vineland Adaptive Behavior Scales-3rd edition. (VABS-3) (5) Receptive and expressive language ability Scores- Receptive- Expressive Emergent Language Test-3rd edition (REEL-3) (6) Total adult word count -Language ENvironment Analysis (LENA) (7) Feasibility and acceptability of delivering the parent mediated intervention - Clinician and parent fidelity formsTimepoint: T1-Baseline T2-12 Weeks after intervention T3- 12 weeks after T2

Countries

India

Contacts

Public ContactDr Shoba Sreenath Meera

National Institute of Mental Health and Neurosciences

ssmeeras@gmail.com9886589656

Outcome results

None listed

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