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Effect of Family Mediated Intervention (FMI) vs Early Intensive Behavioral Intervention (EIBI) in children with Autism spectrum disorder

Comparative Efficacy of Family Mediated Intervention (FMI) vs Early Intensive Behavioral Intervention (EIBI) in children with Autism spectrum disorder: A randomized, open label, active controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027099
Enrollment
50
Registered
2020-08-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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: Family mediated intervention (FMI): FMI (Family mediated intervention) will comprise of sessions of 3-4 hours every fortnightly with family members or parents who cannot come regularly

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All children clinically diagnosed ASD according to DSM 5 2. Children with ASD with age range 2-6 years 3. Parents willing to give informed consent for therapeutic intervention for ASD and to participate in the study

Exclusion criteria

Exclusion criteria: 1. Previous experience with any kind of therapy with significant improvement in clinical symptoms 2. Significant medical or sensory/motor impairments such as a blindness or deafness 3. A traumatic head injury; genetic/neurological condition or disease 4. Significant cognitive impairment 5. Family history of genetic/neurological condition

Design outcomes

Primary

MeasureTime frame
ISAA (Indian Scale for Assessment of Autism )Timepoint: baseline, after 3 months and 6 months

Secondary

MeasureTime frame
developmental domains (measured by Communication DEALL Developmental Checklist)Timepoint: baseline, after 3 months and 6 months;oromotor and sensory deficits (measured by oromotor and sensory profile)Timepoint: baseline, after 3 months and 6 months

Countries

India

Contacts

Public ContactDr Rajeev Ranjan

All India Institute of Medical Sciences, Patna

rajeevranjan0087@gmail.com9717531800

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 8, 2026