Combination Treatment for Augmenting Language in Children With ASD

• Status: Completed
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Treatments: Aripiprazole

Criteria

Inclusion criteria:

• 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.

Exclusion criteria:

• 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.