DRKS00016330CompletedPhase 3
Multicentre, randomized controlled trial of the Frankfurt Early Intervention Program for tod-dlers and preschool children with Autism Spectrum Disorder – A-FFIP - A-FFIP
Goethe Universität Frankfurt am Main0 sites134 target enrollmentStarted: January 4, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 134
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 24 Months to 66 Months (—)
- Sex
- All
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.
Investigators
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