Combination Treatment for Augmenting Language in Children With ASD
Completed · Phase 2 · Has a placebo group
Conditions studied: Autism Spectrum Disorder
In brief
The study will consist of two main elements: the enrollment of 72 children aged 6-11 years with ASD and low language competency to receive a thrice-weekly one hour language intervention for 12 weeks; and, beginning at the same time, subjects will be equally randomized to receive either aripiprazole (Abilify) (flexibly dosed from 2-10 mg per day) or placebo for 12 weeks.
Key facts
- Study ID
- NCT02574741
- Run by
- University of California, Los Angeles
- People needed
- 58
- Starts
- 2012-06-01
- Expected to finish
- 2019-12-01
- Last updated by the study team
- 2020-04-29
Who can join
Age: 5 and older, up to 11. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- boys and girls ages 5-11 years;
- criteria for autistic disorder or PDD-NOS as defined by DSM-IV-TR and confirmed by clinical examination and ADI-R, ADOS;
- low language usage as defined by <30 functional words obtained from a natural language sample, parent report, and standardized tests;
- present placement in a comprehensive educational/intervention setting.
You may not qualify if…
- any medical condition that would interfere with intervention outcomes during a 12 week study period (eg., active seizures within 3 months);
- genetic disorders such as Fragile X, Down syndrome, or tuberous sclerosis;
- sensory impairments such as deafness or blindness;
- existing or anticipated need for concomitant psychotropic medication (specifically stimulants, atomoxetine) during study participation( allowed medication include: antidepressants, anticonvulsants, guanfacine, clonidine, supplements, melatonin, diphenhydramine);
- severe aggression or self-injurious behavior;
- DQ <18 months as assessed by the Leiter-Revised or Mullen.
Where it is running
- University of California — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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