Combination Treatment for Augmenting Language in Children With ASD (PIII)

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

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: Behavioral Therapy; Drug: Aripiprazole; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aripiprazole; Aripiprazole oral solution (1mg/mL) for 12 weeks. dosages range from 2-10mg per day.	Behavioral: Behavioral Therapy; 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.; Other Names: language intervention; Drug: Aripiprazole; 50% of the subjects will be randomized to aripiprazole (active study medication); Other Names: abilify
Active Comparator: Placebo; 50% will be randomized to placebo.	Behavioral: Behavioral Therapy; 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.; Other Names: language intervention; Drug: Placebo; 50% of the subjects will be randomized to placebo (inactive study medication).; Other Names: inactive study medication
Active Comparator: Behavioral Intervention; All subjects will receive behavioral therapy, in addition to either active study drug (aripiprazole) or placebo.	Behavioral: Behavioral Therapy; 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.; Other Names: language intervention; Drug: Aripiprazole; 50% of the subjects will be randomized to aripiprazole (active study medication); Other Names: abilify; Drug: Placebo; 50% of the subjects will be randomized to placebo (inactive study medication).; Other Names: inactive study medication

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: James McCracken, MD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: October 6, 2015
• First Submitted That Met QC Criteria: October 9, 2015
• First Posted (Estimate): October 14, 2015

Study Record Updates

• Last Update Posted (Actual): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole
• Other Study ID Numbers: 12-000726