Combination Treatment for Augmenting Language in Children With ASD
- Conditions
- Autism Spectrum Disorder
- Interventions
- Registration Number
- NCT02574741
- Lead Sponsor
- University of California, Los Angeles
- Brief 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.
- Detailed Description
Following screening for eligibility and baseline, study visits will be scheduled three times per week, with 2 sessions on-site at UCLA and one at home for parent training (allowing flexibility, as needed); study physician visits will occur once weekly for 6 weeks, then biweekly. Screening procedures may be completed in one or two visits, and measures obtained in other UCLA clinical or research setting may be used if assessments were done within one month of screening. Major outcome assessments will occur at baseline (Week 0), mid-point (Week 6), and final week (Week 12) by study personnel blind to visit number and drug group assignment; minor assessments will occur weekly along with study physician assessments occurring weekly for side effect and compliance checks. EEG will occur at or prior to baseline and at Visit 36 (Wk12). Arrangements will be made to transfer participants to standard clinical care following visit 36. Six months after visit 36, families will be seen for final follow-up assessments of language usage, social communication, overall functioning, health and ongoing treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aripiprazole Behavioral Therapy Aripiprazole oral solution (1mg/mL) for 12 weeks. dosages range from 2-10mg per day. Placebo Placebo 50% will be randomized to placebo. Behavioral Intervention Behavioral Therapy All subjects will receive behavioral therapy, in addition to either active study drug (aripiprazole) or placebo. Behavioral Intervention Placebo All subjects will receive behavioral therapy, in addition to either active study drug (aripiprazole) or placebo. Aripiprazole Aripiprazole Aripiprazole oral solution (1mg/mL) for 12 weeks. dosages range from 2-10mg per day. Placebo Behavioral Therapy 50% will be randomized to placebo. Behavioral Intervention Aripiprazole All subjects will receive behavioral therapy, in addition to either active study drug (aripiprazole) or placebo.
- Primary Outcome Measures
Name Time Method Number of words as assessed in a naturalistic language assessment 12 weeks post baseline word usage coded as assessed by a clinician-administered assessment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of California
🇺🇸Los Angeles, California, United States