Autism Spectrum DisorderPhase 2PIIINCT02574741
Combination Treatment for Augmenting Language in Children With ASD
A Phase 2 study testing Behavioral Therapy and Aripiprazole in people with Autism Spectrum Disorder, run by University of California, Los Angeles at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Behavioral Therapy and Aripiprazole
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California
Los Angeles, California, 90095
About this study
Official title: 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.
Read the 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
- Being tested
- Behavioral Therapy, Aripiprazole, Placebo
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral TherapyBehavioural
Also called language intervention
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.
AripiprazoleDrug
Also called abilify
50% of the subjects will be randomized to aripiprazole (active study medication)
PlaceboDrug
Also called inactive study medication
50% of the subjects will be randomized to placebo (inactive study medication).
| Study group | Role | What they receive |
|---|---|---|
| Aripiprazole | Active comparator | Aripiprazole oral solution (1mg/mL) for 12 weeks. dosages range from 2-10mg per day. Receives: Behavioral: Behavioral Therapy; Drug: Aripiprazole |
| Placebo | Active comparator | 50% will be randomized to placebo. Receives: 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. Receives: Behavioral: Behavioral Therapy; Drug: Aripiprazole; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of words as assessed in a naturalistic language assessment
word usage coded as assessed by a clinician-administered assessment
Measured: 12 weeks post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startJun 2012
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James McCracken, University of California, Los Angeles
- Investigators
- James McCracken, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574741
- Sponsor's protocol ID
- 12-000726
- Acronym
- PIII
- Status last verified
- Apr 2020
- First submitted
- 6 Oct 2015
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting Language Interventions in ASD: A Translational Approach (ACE Project 3)
- ClinicalTrials.gov ID
- NCT02574741
- Acronym / sponsor ID
- PIII / 12-000726
- Conditions
- Autism Spectrum Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 14 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aripiprazole | Active comparator | Behavioral: Behavioral Therapy, Drug: AripiprazoleAripiprazole oral solution (1mg/mL) for 12 weeks. dosages range from 2-10mg per day. |
| Placebo | Active comparator | Behavioral: Behavioral Therapy, Drug: Placebo50% will be randomized to placebo. |
| Behavioral Intervention | Active comparator | Behavioral: Behavioral Therapy, Drug: Aripiprazole, Drug: PlaceboAll subjects will receive behavioral therapy, in addition to either active study drug (aripiprazole) or placebo. |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral TherapyAlso: language interventionThrice-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. | Behavioural | Aripiprazole, Behavioral Intervention, Placebo |
| AripiprazoleAlso: abilify50% of the subjects will be randomized to aripiprazole (active study medication) | Drug | Aripiprazole, Behavioral Intervention |
| PlaceboAlso: inactive study medication50% of the subjects will be randomized to placebo (inactive study medication). | Drug | Behavioral Intervention, Placebo |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James McCracken, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Behavioral Therapy and Aripiprazole in people with Autism Spectrum Disorder, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of words as assessed in a naturalistic language assessment (time frame: 12 weeks post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020; AzTrials last refreshed its copy on 2 Nov 2026.