Combination Treatment for Augmenting Language in Children With ASD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Augmenting Language Interventions in ASD: A Translational Approach (ACE Project 3)

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: Behavioral Therapy
* Drug: Aripiprazole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aripiprazole<br>Aripiprazole oral solution (1mg/mL) for 12 weeks. dosages range from 2-10mg per day. | Behavioral: Behavioral Therapy<br>* Thrice-weekly individually based language JAE-EMT intervention will be provided by a trained therapist and taught to the child and their caregivers. A total of 36 sessions will be provided over 12 weeks, with 2 per week at UCLA, and one session per week in the home.<br>* Other names: language intervention;Drug: Aripiprazole<br>* 50% of the subjects will be randomized to aripiprazole (active study medication)<br>* Other names: abilify;|
| Active Comparator: Placebo<br>50% will be randomized to placebo. | Behavioral: Behavioral Therapy<br>* Thrice-weekly individually based language JAE-EMT intervention will be provided by a trained therapist and taught to the child and their caregivers. A total of 36 sessions will be provided over 12 weeks, with 2 per week at UCLA, and one session per week in the home.<br>* Other names: language intervention;Drug: Placebo<br>* 50% of the subjects will be randomized to placebo (inactive study medication).<br>* Other names: inactive study medication;|
| Active Comparator: Behavioral Intervention<br>All subjects will receive behavioral therapy, in addition to either active study drug (aripiprazole) or placebo. | Behavioral: Behavioral Therapy<br>* Thrice-weekly individually based language JAE-EMT intervention will be provided by a trained therapist and taught to the child and their caregivers. A total of 36 sessions will be provided over 12 weeks, with 2 per week at UCLA, and one session per week in the home.<br>* Other names: language intervention;Drug: Aripiprazole<br>* 50% of the subjects will be randomized to aripiprazole (active study medication)<br>* Other names: abilify;Drug: Placebo<br>* 50% of the subjects will be randomized to placebo (inactive study medication).<br>* Other names: inactive study medication;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of words as assessed in a naturalistic language assessment | word usage coded as assessed by a clinician-administered assessment | 12 weeks post baseline |