PIII: Combination Treatment for Augmenting Language in Children With ASD
Study Details
Study Description
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 |
|---|---|---|
|
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 Design
Arms and Interventions
| 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:
Drug: Aripiprazole
50% of the subjects will be randomized to aripiprazole (active study medication)
Other Names:
|
| 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:
Drug: Placebo
50% of the subjects will be randomized to placebo (inactive study medication).
Other Names:
|
| 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:
Drug: Aripiprazole
50% of the subjects will be randomized to aripiprazole (active study medication)
Other Names:
Drug: Placebo
50% of the subjects will be randomized to placebo (inactive study medication).
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of words as assessed in a naturalistic language assessment [12 weeks post baseline]
word usage coded as assessed by a clinician-administered assessment
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California | Los Angeles | California | United States | 90095 |
Sponsors and Collaborators
- University of California, Los Angeles
Investigators
- Principal Investigator: James McCracken, MD, University of California, Los Angeles
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 12-000726