Combination Treatment for Augmenting Language in Children With ASD

NCT ID: NCT02574741

Last Updated: 2020-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2019-12-31

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.

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.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Aripiprazole

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

Group Type: ACTIVE_COMPARATOR

Behavioral Therapy

Intervention Type: 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.

Aripiprazole

Intervention Type: DRUG

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

Placebo

50% will be randomized to placebo.

Group Type: ACTIVE_COMPARATOR

Behavioral Therapy

Intervention Type: 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.

Placebo

Intervention Type: DRUG

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

Behavioral Intervention

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

Group Type: ACTIVE_COMPARATOR

Behavioral Therapy

Intervention Type: 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.

Aripiprazole

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: BEHAVIORAL

Aripiprazole

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

language intervention; abilify; inactive study medication

Eligibility 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

James McCracken

Director/Vice Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James McCracken, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

University of California

Los Angeles, California, United States

Countries

United States

Other Identifiers

12-000726

Identifier Type: -

Identifier Source: org_study_id