Autistic DisorderNCT01258465
Research in Autism: Parent Intervention
A study testing Pivotal Response Training and Picture Exchange Communication System in people with Autistic Disorder, run by University of California, San Diego at 2 sites in United States.
Trial summary
The purpose of this research project was to systematically compare two widely used types of intervention programs for children with autism within a parent training model. In one condition, randomly assigned children were provided with an intervention that typically results in acquisition of expressive words in a large… Read more about this study
- Who is it for?
- Ages 24 to 47 months
- Conditions the study is for
- Autistic Disorder
- What is being tested?
- Pivotal Response Training and Picture Exchange Communication System
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2005to Dec 2009
- Phase
- Interventional
- 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 24 to 47 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of Autistic Disorder or At Risk of Autistic Disorder
- Age 2-0 to 3-11 years of age
- Use of fewer than 10 functional words at intake
Who cannot join
- Primary diagnosis of mental retardation
- Neurologic pathology (e.g., PKU, encephalitis, brain trauma)
- Major sensory impairment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, San Diego Psychology Department
La Jolla, California, 92093-0109
University of California, Santa Barbara, School of Education, Department of Clinical, Counseling, and School Psychology
Santa Barbara, California, 93108
About this study
The purpose of this research project was to systematically compare two widely used types of intervention programs for children with autism within a parent training model. In one condition, randomly assigned children were provided with an intervention that typically results in acquisition of expressive words in a large percentage of children diagnosed as having autism, using a well-documented manualized intervention focused on verbal expressive communication only (Pivotal Response Training, PRT). In the other condi¬tion, randomly assigned children received a widely used intervention on the same social communication functions using a well-documented manualized augmentative system of intervention (Picture Exchange Communica¬tion System, PECS) that has been reported to produce verbal and nonverbal communication in large percentages of children diagnosed with autism. Children in the two conditions were compared for development of verbal and nonverbal communication, changes in disruptive behavior, changes in symptoms of autism, and general adaptive behavior gains. In addition, parent satisfaction and stress measures were gathered in order to assess the effects of each intervention on family functioning.
- Conditions
- Autistic Disorder
- Being tested
- Pivotal Response Training, Picture Exchange Communication System
- Keywords
- Communication, Pivotal Response Training, Picture Exchange Communication System
- Medical subject headings
- Autistic Disorder, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pivotal Response TrainingBehavioural
Naturalistic behavioral protocol designed to teach vocal communication.
Picture Exchange Communication SystemBehavioural
Pictorially-based behavioral protocol designed to teach communication to nonverbal children via pictures icons.
| Study group | Role | What they receive |
|---|---|---|
| Pivotal Response Training | Active comparator | A naturalistic behavioral intervention designed to facilitate verbal communication. Receives: Behavioral: Pivotal Response Training; Behavioral: Picture Exchange Communication System |
| Picture Exchange Communication System | Active comparator | Pictorially-based behavioral protocol designed to facilitate communication via picture icons. Receives: Behavioral: Picture Exchange Communication System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mullen Scales of Early Learning
Measured: 23 weeks with three months follow-up
Secondary outcomes (1)
Vineland Adaptive Behavior Scales
Measured: 23 weeks and 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2010 (estimated)
- Study startJan 2005
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Investigators
- Laura E Schreibman, Ph.D., Principal investigator, University of California, San DiegoRobert L Koegel, Ph.D., Principal investigator, University of California, Santa Barbara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258465
- Sponsor's protocol ID
- MH39434
- Status last verified
- Dec 2010
- First submitted
- 10 Dec 2010
- Last updated
- 13 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research in Autism: Parent Intervention
- ClinicalTrials.gov ID
- NCT01258465
- Acronym / sponsor ID
- MH39434
- Conditions
- Autistic Disorder
- Keywords
- Communication, Pivotal Response Training, Picture Exchange Communication System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 13 Dec 2010 (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 purpose of this research project was to systematically compare two widely used types of intervention programs for children with autism within a parent training model. In one condition, randomly assigned children were provided with an intervention that typically results in acquisition of expressive words in a large percentage of children diagnosed as having autism, using a well-documented manualized intervention focused on verbal expressive communication only (Pivotal Response Training, PRT). In the other condi¬tion, randomly assigned children received a widely used intervention on the same social communication functions using a well-documented manualized augmentative system of intervention (Picture Exchange Communica¬tion System, PECS) that has been reported to produce verbal and nonverbal communication in large percentages of children diagnosed with autism. Children in the two conditions were compared for development of verbal and nonverbal communication, changes in disruptive behavior, changes in symptoms of autism, and general adaptive behavior gains. In addition, parent satisfaction and stress measures were gathered in order to assess the effects of each intervention on family functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pivotal Response Training | Active comparator | Behavioral: Pivotal Response Training, Behavioral: Picture Exchange Communication SystemA naturalistic behavioral intervention designed to facilitate verbal communication. |
| Picture Exchange Communication System | Active comparator | Behavioral: Picture Exchange Communication SystemPictorially-based behavioral protocol designed to facilitate communication via picture icons. |
Who may qualify
- Ages
- 24 to 47 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosis of Autistic Disorder or At Risk of Autistic Disorder
- Age 2-0 to 3-11 years of age
- Use of fewer than 10 functional words at intake
Key exclusion criteria (3 listed)
- Primary diagnosis of mental retardation
- Neurologic pathology (e.g., PKU, encephalitis, brain trauma)
- Major sensory impairment
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 |
|---|---|---|
| Pivotal Response TrainingNaturalistic behavioral protocol designed to teach vocal communication. | Behavioural | Pivotal Response Training |
| Picture Exchange Communication SystemPictorially-based behavioral protocol designed to teach communication to nonverbal children via pictures icons. | Behavioural | Picture Exchange Communication System, Pivotal Response Training |
Primary outcome
Mullen Scales of Early Learning
Time frame: 23 weeks with three months follow-up
1 secondary outcome
Vineland Adaptive Behavior Scales
Time frame: 23 weeks and 3 month follow up
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 13 Dec 2010.
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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.
Laura E Schreibman, Ph.D. principal investigator
University of California, San Diego
Robert L Koegel, Ph.D. principal investigator
University of California, Santa Barbara
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pivotal Response Training and Picture Exchange Communication System in people with Autistic Disorder, run by University of California, San Diego at 2 sites 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 3 inclusion and 3 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 13 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Mullen Scales of Early Learning (time frame: 23 weeks with three months follow-up). 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 13 Dec 2010.