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

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ClinicalTrials.gov Identifier: NCT02574741
Recruitment Status : Recruiting
First Posted : October 14, 2015
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
James McCracken, 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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Behavioral Therapy Drug: Aripiprazole Drug: Placebo Phase 2

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  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Augmenting Language Interventions in ASD: A Translational Approach (ACE Project 3)
Study Start Date : June 2012
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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 Name: language intervention

Drug: Aripiprazole
50% of the subjects will be randomized to aripiprazole (active study medication)
Other Name: 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 Name: language intervention

Drug: Placebo
50% of the subjects will be randomized to placebo (inactive study medication).
Other Name: 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 Name: language intervention

Drug: Aripiprazole
50% of the subjects will be randomized to aripiprazole (active study medication)
Other Name: abilify

Drug: Placebo
50% of the subjects will be randomized to placebo (inactive study medication).
Other Name: inactive study medication




Primary Outcome Measures :
  1. Number of words as assessed in a naturalistic language assessment [ Time Frame: 12 weeks post baseline ]
    word usage coded as assessed by a clinician-administered assessment



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Ages Eligible for Study:   5 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02574741


Contacts
Contact: Jenny Cowen, PhD 310-825-6170 jcowen@mednet.ucla.edu

Locations
United States, California
University of California Recruiting
Los Angeles, California, United States, 90095
Contact: Jennifer Cowen, PhD    310-825-6170    jcowen@mednet.ucla.edu   
Principal Investigator: James T. McCracken, MD         
Principal Investigator: Connie Kasari, PhD         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: James McCracken, MD University of California, Los Angeles

Responsible Party: James McCracken, Director/Vice Chair, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02574741     History of Changes
Other Study ID Numbers: 12-000726
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs