Autistic DisorderNCT01400269
An Evaluation of a Developmentally-Based Parent Training Program for Children With Autism
A study testing Pacific Autism Center for Education (PACE ) developmentally based parent delivered intervention in people with Autistic Disorder, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to assess the efficacy of a parent training program in the treatment of social and communication deficits in children with autism. Specifically, this study will evaluate a developmentally based parent delivered intervention in the community developed by Pacific Autism Center for Education… Read more about this study
- Who is it for?
- Ages 18 months to 6 years
- Conditions the study is for
- Autistic Disorder
- What is being tested?
- Pacific Autism Center for Education (PACE ) developmentally based parent delivered intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jan 2014
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- meets DSM-IV-TR criteria for an autism spectrum disorder (pervasive developmental disorder) on the basis of clinical evaluation and the research diagnostic methods
- age range between 18 months and 6.11 years
- male or female in good medical health
- will be starting PACE parent training program
- intends on continuing PACE program for a minimum of 12 weeks
Who cannot join
- medically unstable (e.g., more than one seizure a month)
- a medical diagnosis that causes autism like symptomology (e.g., Fragile X, Down syndrome, Angelman's syndrome, tuberous sclerosis, Rett's disorder)
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
The purpose of this study is to assess the efficacy of a parent training program in the treatment of social and communication deficits in children with autism. Specifically, this study will evaluate a developmentally based parent delivered intervention in the community developed by Pacific Autism Center for Education (PACE).
Read the detailed description
There are many treatments that claim to be effective for children with autism; however many of these treatments have not been investigated using scientifically rigorous methodology. A variety of developmentally based parent delivered interventions are gaining popularity as a type of treatment parents utilize to improve symptoms related to their child's diagnosis of autism. Pacific Autism Center for Education (PACE)is a agency that provides a developmentally based parent delivered intervention in the community. Currently, this parent training program has not been evaluated using scientific methodology. Investigation into this community delivered treatment and its effectiveness to improve social and communication deficits will aid clinicians in providing better care for children with autism.
- Conditions
- Autistic Disorder
- Being tested
- Pacific Autism Center for Education (PACE ) developmentally based parent delivered intervention
- Keywords
- PACE
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacific Autism Center for Education (PACE ) developmentally based parent delivered interventionBehavioural
Pacific Autism Center for Education (PACE ) developmentally based parent delivered intervention
| Study group | Role | What they receive |
|---|---|---|
| Pacific Autism Center for Education (PACE) | Experimental | Behavioral: Pacific Autism Center for Education (PACE) developmentally based parent delivered intervention Receives: Behavioral: Pacific Autism Center for Education (PACE ) developmentally based parent delivered intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Responsiveness Scale
Outcome measure is the change from week 12 relative to baseline.
Measured: Baseline and Week 12
Secondary outcomes (5)
Repetitive Behavior Scale
Outcome measure is the change from week 12 relative to baseline.
Measured: Baseline and Week 12
Family Empowerment Scale
Outcome measure is the change from week 12 relative to baseline.
Measured: Baseline and Week 12
Caregiver Strain questionnaire
Outcome measure is the change from week 12 relative to baseline.
Measured: Baseline and Week 12
Pediatric Quality of Life Inventory
Outcome measure is the change from week 12 relative to baseline.
Measured: Baseline and Week 12
Sensory Profile Questionnaire
Outcome measure is the change from week 12 relative to baseline.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startSep 2010
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 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, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400269
- Sponsor's protocol ID
- SU-11022010-7169
- Status last verified
- Feb 2022
- First submitted
- 31 May 2011
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Gengoux GW, Schapp S, Burton S, Ardel CM, Libove RA, Baldi G, Berquist KL, Phillips JM, Hardan AY. Effects of a parent-implemented Developmental Reciprocity Treatment Program for children with autism spectrum disorder. Autism. 2019 Apr;23(3):713-725. doi: 10.1177/1362361318775538. Epub 2018 May 18.
PubMed 29775078
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of a Developmentally-Based Parent Training Program for Children With Autism
- ClinicalTrials.gov ID
- NCT01400269
- Acronym / sponsor ID
- SU-11022010-7169
- Conditions
- Autistic Disorder
- Keywords
- PACE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 22 Jul 2011 (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 study is to assess the efficacy of a parent training program in the treatment of social and communication deficits in children with autism. Specifically, this study will evaluate a developmentally based parent delivered intervention in the community developed by Pacific Autism Center for Education (PACE).
Detailed description
There are many treatments that claim to be effective for children with autism; however many of these treatments have not been investigated using scientifically rigorous methodology. A variety of developmentally based parent delivered interventions are gaining popularity as a type of treatment parents utilize to improve symptoms related to their child's diagnosis of autism. Pacific Autism Center for Education (PACE)is a agency that provides a developmentally based parent delivered intervention in the community. Currently, this parent training program has not been evaluated using scientific methodology. Investigation into this community delivered treatment and its effectiveness to improve social and communication deficits will aid clinicians in providing better care for children with autism.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pacific Autism Center for Education (PACE) | Experimental | Behavioral: Pacific Autism Center for Education (PACE ) developmentally based parent delivered interventionBehavioral: Pacific Autism Center for Education (PACE) developmentally based parent delivered intervention |
Who may qualify
- Ages
- 18 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- meets DSM-IV-TR criteria for an autism spectrum disorder (pervasive developmental disorder) on the basis of clinical evaluation and the research diagnostic methods
- age range between 18 months and 6.11 years
- male or female in good medical health
- will be starting PACE parent training program
- intends on continuing PACE program for a minimum of 12 weeks
Key exclusion criteria (2 listed)
- medically unstable (e.g., more than one seizure a month)
- a medical diagnosis that causes autism like symptomology (e.g., Fragile X, Down syndrome, Angelman's syndrome, tuberous sclerosis, Rett's disorder)
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 |
|---|---|---|
| Pacific Autism Center for Education (PACE ) developmentally based parent delivered interventionPacific Autism Center for Education (PACE ) developmentally based parent delivered intervention | Behavioural | Pacific Autism Center for Education (PACE) |
Primary outcome
Social Responsiveness Scale
Time frame: Baseline and Week 12
Outcome measure is the change from week 12 relative to baseline.
5 secondary outcomes
Repetitive Behavior Scale
Time frame: Baseline and Week 12
Family Empowerment Scale
Time frame: Baseline and Week 12
Caregiver Strain questionnaire
Time frame: Baseline and Week 12
Pediatric Quality of Life Inventory
Time frame: Baseline and Week 12
Sensory Profile Questionnaire
Time frame: Baseline and 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 16 Feb 2022.
- Results publication: PubMed 29775078Gengoux GW, Schapp S, Burton S, Ardel CM, Libove RA, Baldi G, Berquist KL, Phillips JM, Hardan AY. Effects of a parent-implemented Developmental Reciprocity Treatment Program for children with autism spectrum disorder. Autism. 2019 Apr;23(3):713-725. doi: 10.1177/1362361318775538. Epub 2018 May 18.
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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, MD 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 Pacific Autism Center for Education (PACE ) developmentally based parent delivered intervention in people with Autistic Disorder, 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 5 inclusion and 2 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 16 Feb 2022. 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?
Social Responsiveness Scale (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01400269, which also lists 1 linked publication.
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 16 Feb 2022.