Early Treatment of Language Impairment in Young Children With Autism Spectrum Disorder With Leuco… (NCT04060017) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Early Treatment of Language Impairment in Young Children With Autism Spectrum Disorder With Leucovorin Calcium
United States80 participantsStarted 2020-09-22
Plain-language summary
The primary objective of this study is to evaluate the cognitive and behavioral effects of liquid leucovorin calcium on young children with autism spectrum disorder (ASD) and determine whether it improves language as well as the core and associated symptoms of ASD. The investigators will enroll 80 children across two sites, between the ages of 2.5 and 5 years, with confirmed ASD and known language delays or impairments. Participation will last approximately 26 weeks from screening to end of treatment.
Who can participate
Age range30 Months – 60 Months
SexALL
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Inclusion criteria
✓. Autism Spectrum Disorder (as defined below).
✓. Between 2 years 6 months and 5 years 2 months of age at baseline
✓. Language impairment (Ages and Stage Questionnaire between -1 and -3 SD for Language)
✓. Has at least 4 month old expressive language ability as assessed by the MSEL Expressive Language Scale (i.e., Parent answers "yes" to " Voluntary babbling (such as 'bu, bu, bu")" Question #7 on the MSEL Expressive Language Scale.
✓. English included in the languages in which the child is being raised
✓. Autism severity of moderate or higher (≥4) under the 7-item clinical global impression-severity scale. Moderate level of autism severity (4) is defined by the diagnosis of ASD with language impairment, so fulfilling #1 and #4 fulfills this requirement.
Exclusion criteria
✕. Known FRAA status by clinically validated test performed outside of research studies.
✕. Mineral or vitamin supplementation that exceeds the Tolerable Upper Daily Intake Levels set by the Institute of Medicine (See Table 5 below)
What they're measuring
1
Evaluate the change in measures of expressive language
Timeframe: Screening, Week 12, Week 24
Trial details
NCT IDNCT04060017
SponsorSouthwest Autism Research & Resource Center