Combination Treatment for Augmenting Language in Children With ASD

NCT02574741 | Completed Phase 2 DMC

• 1 other identifier: 12-000726
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Number of words as assessed in a naturalistic language assessment

  word usage coded as assessed by a clinician-administered assessment

  12 weeks post baseline

Study Arms (3)

Aripiprazole

ACTIVE COMPARATOR

Aripiprazole oral solution (1mg/mL) for 12 weeks. dosages range from 2-10mg per day.

Behavioral: Behavioral Therapy; Drug: Aripiprazole

Placebo

ACTIVE COMPARATOR

50% will be randomized to placebo.

Behavioral: Behavioral Therapy; Drug: Placebo

Behavioral Intervention

ACTIVE COMPARATOR

All subjects will receive behavioral therapy, in addition to either active study drug (aripiprazole) or placebo.

Behavioral: Behavioral Therapy; Drug: Aripiprazole; Drug: Placebo

Interventions

Behavioral Therapy BEHAVIORAL

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.

Also known as: language intervention

Aripiprazole; Behavioral Intervention; Placebo

Aripiprazole DRUG

50% of the subjects will be randomized to aripiprazole (active study medication)

Also known as: abilify

Aripiprazole; Behavioral Intervention

Placebo DRUG

50% of the subjects will be randomized to placebo (inactive study medication).

Also known as: inactive study medication

Behavioral Intervention; Placebo

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Behavior Therapy; Aripiprazole

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• James McCracken, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director/Vice Chair

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 14, 2015
• Study Start: June 1, 2012
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 29, 2020

Record last verified: 2020-04

Locations

US (1)