Multicentre, randomized controlled trial of the Frankfurt Early Intervention Program for tod-dlers and preschool children with Autism Spectrum Disorder – A-FFIP
Phase 3
- Conditions
- DSM-5: 299.0 Autism Spectrum DisorderF84.0F84.5Childhood autismAsperger syndrome
- Registration Number
- DRKS00016330
- Lead Sponsor
- Goethe Universität Frankfurt am Main
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 134
Inclusion Criteria
Autism Spectrum Disorder according to DSM-5
Exclusion Criteria
Key exclusion criteria: non-verbal IQ/DQ <= 30, non-verbal mental age < =12 months, sensory impairments, cerebral palsy, chronic neurological disorder, unstable epilepsy, neurodegenerative disorder, Rett / Angelman Syndrome, severe psychosocial deprivation, insufficient care by parents, attachment disorder, institutional upbringing, parents not verbally fluent in German and/or unable to read German. Amendment from October 16, 2018: A correction of the key exclusion criteria from non-verbal IQ/DQ <40, non-verbal mental age < 15 months to non-verbal IQ/DQ <= 30, non-verbal mental age < =12 months was submitted. The ethics commission accepted this on January 24, 2019.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method