Autistic DisorderNCT01882153
Evaluating Parent Delivered Interventions for Children With Autism
A study testing Pivotal Response Training (PRT), PACE Therapy and PACE and PRT Hybrid in people with Autistic Disorder and Developmental Disabilities, run by Stanford University at 1 site in United States.
Trial summary
The investigators will assess the efficacy of parent delivered interventions in the treatment of social and communication deficits in children with autism. By collecting information about parent and child functioning before and after intervention, the investigators will be able to determine whether the intervention is… Read more about this study
- Who is it for?
- Ages 18 months to 17 years
- Conditions the study is for
- Autistic Disorder, Developmental Disabilities
- What is being tested?
- Pivotal Response Training (PRT), PACE Therapy and PACE and PRT Hybrid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to 18 Feb 2022
- 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 18 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between the ages of 1.6 and 17.11 years of age
- Males and females
- Diagnosis of autism based on DSM-IV-TR criteria, an expert clinical evaluation, and ADOS or ADI-R if needed
- Receiving or will receive a parent delivered intervention to alleviate symptoms related to their diagnosis of autistic disorder
- Have a care provider that will reliably bring subjects to their chosen intervention and clinic visits, and is trustworthy to provide accurate accounts of services provided to the subject
- Inclusion Criteria for developmentally delayed participants:
Show all 12Show fewer
- Will have an age range between 1.6 and 17.11 years of age
- Males or females
- Diagnosis of a developmental delay or disorder based on DSM-IV-TR, ICD-10, and an expert clinical evaluation
- Have historical evidence of significant abnormal developmental milestones as determined by neurological history
- Receiving or will receive a parent delivered intervention
- Have a care provider that will reliably bring subjects to their chosen intervention and clinic visits, and is trustworthy to provide accurate accounts of services provided to the subject
Who cannot join
- Is medically unstable (e.g., more than one seizure a month)
- Have a medical diagnosis that causes autism like symptomology (e.g., Fragile X, Down syndrome, Angelman's syndrome, tuberous sclerosis, Rett's disorder)
- Is medically unstable (e.g., more than one seizure a month)
- Has a diagnosis of ASD
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
The investigators will assess the efficacy of parent delivered interventions in the treatment of social and communication deficits in children with autism. By collecting information about parent and child functioning before and after intervention, the investigators will be able to determine whether the intervention is effective in improving child social communication and reducing parent stress.
- Conditions
- Autistic Disorder, Developmental Disabilities
- Being tested
- Pivotal Response Training (PRT), PACE Therapy, PACE and PRT Hybrid
- Medical subject headings
- Autistic Disorder, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pivotal Response Training (PRT)Behavioural
The behaviorally-based intervention is a treatment model that uses the principles of Applied Behavior Analysis (Koegel, Openden, Fredeen, \& Koegel, 2006) to increase children's adaptive behaviors and decrease maladaptive behaviors.
PACE TherapyBehavioural
The developmentally based intervention is grounded in a development theory, that focuses on child-directed interactions with warm and caring individuals that aid in acquiring missed developmental and functional milestones.
PACE and PRT HybridBehavioural
The hybrid based treatment has an eclectic approach that incorporates both systematic (behaviorally-based) and affect-based learning (developmentally-based)that focuses on increasing children's skill development (http://www.pacificautism.org).
| Study group | Role | What they receive |
|---|---|---|
| Developmentally Based Intervention | Experimental | Not described Receives: Behavioral: PACE Therapy; Behavioral: PACE and PRT Hybrid |
| Behaviorally Based Intervention | Experimental | Not described Receives: Behavioral: Pivotal Response Training (PRT); Behavioral: PACE and PRT Hybrid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CGI-S (Clinical Global Impression - Severity)
Measured: Difference from Baseline to Week 12
Change in SRS (Social Responsiveness Scale)
Measured: Difference from Baseline to Week 12
Change in CDI (Communicative Development Survey) Score
Measured: Difference from Baseline to Week 12
Change in social and communication behaviors as assessed by standardized laboratory observations
Measured: Difference from Baseline to Week 12
Secondary outcomes (6)
Change in VABS (Vineland Adaptive Behavior Scale) Score
Measured: Difference from Baseline to Week 12
Change in social and communication behaviors as assessed from home videos
Measured: Difference from Baseline to Week 12
Change in PSI (Parenting Stress Index) Score
Measured: Difference from Baseline to Week 12
Change in FES (Family Empowerment Scale) Score
Measured: Difference from Baseline to Week 12
Change in frequency and duration of investigation therapy
Measured: Difference from Baseline to Week 12
Change in demographics data
Measured: Difference from Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startFeb 2010
- Primary completion18 Feb 2022
- Study completion18 Feb 2022
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.
- More trials run by Stanford UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Hardan, Stanford University
- Investigators
- Antonio Y Hardan, M.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882153
- Sponsor's protocol ID
- SU-11232011-8727
- Status last verified
- Jul 2023
- First submitted
- 17 Jun 2013
- Last updated
- 14 Jul 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Parent Delivered Interventions for Children With Autism
- ClinicalTrials.gov ID
- NCT01882153
- Acronym / sponsor ID
- SU-11232011-8727
- Conditions
- Autistic Disorder, Developmental Disabilities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Feb 2010 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 18 Feb 2022 (actual)
- First posted
- 20 Jun 2013 (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 investigators will assess the efficacy of parent delivered interventions in the treatment of social and communication deficits in children with autism. By collecting information about parent and child functioning before and after intervention, the investigators will be able to determine whether the intervention is effective in improving child social communication and reducing parent stress.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Developmentally Based Intervention | Experimental | Behavioral: PACE Therapy, Behavioral: PACE and PRT Hybrid |
| Behaviorally Based Intervention | Experimental | Behavioral: Pivotal Response Training (PRT), Behavioral: PACE and PRT Hybrid |
Who may qualify
- Ages
- 18 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Children between the ages of 1.6 and 17.11 years of age
- Males and females
- Diagnosis of autism based on DSM-IV-TR criteria, an expert clinical evaluation, and ADOS or ADI-R if needed
- Receiving or will receive a parent delivered intervention to alleviate symptoms related to their diagnosis of autistic disorder
- Have a care provider that will reliably bring subjects to their chosen intervention and clinic visits, and is trustworthy to provide accurate accounts of services provided to the subject
Key exclusion criteria (4 listed)
- Is medically unstable (e.g., more than one seizure a month)
- Have a medical diagnosis that causes autism like symptomology (e.g., Fragile X, Down syndrome, Angelman's syndrome, tuberous sclerosis, Rett's disorder)
- Is medically unstable (e.g., more than one seizure a month)
- Has a diagnosis of ASD
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 Training (PRT)The behaviorally-based intervention is a treatment model that uses the principles of Applied Behavior Analysis (Koegel, Openden, Fredeen, \& Koegel, 2006) to increase children's adaptive behaviors and decrease maladaptive behaviors. | Behavioural | Behaviorally Based Intervention |
| PACE TherapyThe developmentally based intervention is grounded in a development theory, that focuses on child-directed interactions with warm and caring individuals that aid in acquiring missed developmental and functional milestones. | Behavioural | Developmentally Based Intervention |
| PACE and PRT HybridThe hybrid based treatment has an eclectic approach that incorporates both systematic (behaviorally-based) and affect-based learning (developmentally-based)that focuses on increasing children's skill development (http://www.pacificautism.org). | Behavioural | Behaviorally Based Intervention, Developmentally Based Intervention |
Primary outcome
Change in CGI-S (Clinical Global Impression - Severity)
Time frame: Difference from Baseline to Week 12
Change in SRS (Social Responsiveness Scale)
Time frame: Difference from Baseline to Week 12
Change in CDI (Communicative Development Survey) Score
Time frame: Difference from Baseline to Week 12
Change in social and communication behaviors as assessed by standardized laboratory observations
Time frame: Difference from Baseline to Week 12
6 secondary outcomes
Change in VABS (Vineland Adaptive Behavior Scale) Score
Time frame: Difference from Baseline to Week 12
Change in social and communication behaviors as assessed from home videos
Time frame: Difference from Baseline to Week 12
Change in PSI (Parenting Stress Index) Score
Time frame: Difference from Baseline to Week 12
Change in FES (Family Empowerment Scale) Score
Time frame: Difference from Baseline to Week 12
Change in frequency and duration of investigation therapy
Time frame: Difference from Baseline to Week 12
Change in demographics data
Time frame: Difference from Baseline to Week 12
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 14 Jul 2023.
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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.
Antonio Y Hardan, M.D. principal investigator
Stanford University
1 site 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 (PRT), PACE Therapy and PACE and PRT Hybrid in people with Autistic Disorder and Developmental Disabilities, run by Stanford University 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 12 inclusion and 4 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 14 Jul 2023. 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.
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?
Change in CGI-S (Clinical Global Impression - Severity) (time frame: Difference from Baseline to Week 12). The study lists 4 primary outcomes in all. 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 14 Jul 2023; AzTrials last refreshed its copy on 1 Nov 2026.