Autism Spectrum DisordersNCT00938054
Identification of Characteristics Associated With Symptom Remission in Autism
An observational study of Autism Spectrum Disorders and Autism, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
Autism is defined as a lifelong pervasive developmental disability, as such, symptom recovery is considered rare. Reports by Lovaas and McEachin, Smith \& Lovaas and more recently by Cohen, Amerine-Dickens, \& Smith, Smith Groen et al. Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorders, Autism
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2009to 9 Oct 2012
- Phase
- Observational
- 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 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- STUDY SUBJECTS:
- Remitted Autism (REM-AUT) Group:
- Diagnosis of autism prior to symptom improvement
- valid administration of ADI and/or ADOS with accompanying interpretive report yielding an autism diagnosis
- OR
- clinical/developmental evaluation including a detailed review of the child s history and direct observation of current behavioral functioning resulting in a documented diagnosis of autism by a child developmental specialist experienced with autism spectrum disorders such as a developmental pediatrician, developmental psychologist, child clinical psychologist, or a child psychiatrist
Show all 31Show fewer
- measure of cognitive ability from within 1 year of initial autism diagnosis
- objective measure indicative of prominent autism symptoms using a recognized and standardized assessment of autism symptoms such as the Social Responsiveness Scale (SRS), Childhood Autism Rating Scale (CARS), or the Modified Checklist for Autism in Toddlers (MCHAT) or video tapes of assessments
- initial diagnosis of autism prior to age 6
- AND
- Medical, educational, treatment record review by PDN branch clinicians to confirm diagnostic impressions including a detailed description of child s behaviors that support an autism diagnosis
- The final decision for meeting diagnostic and treatment history inclusion criteria is based on PDN branch staff review of the case
- Treatment history: all participants must have received adequate treatment intervention for their autism symptoms. Participant medical and treatment records will be carefully reviewed to ascertain their treatment history
- Current functioning:
- Parent report and report of at least one professional that child is no longer autistic
- At screening visit (after meeting initial eligibility), will not meet criteria for autism
- Must not meet criteria for autism per overall clinical impression based on information collected from administration of the ADOS, current ADI-R symptoms, and other clinical observations made the assessment.
- Teacher/informant report of autism symptoms (such as results from the SRS) not indicative of autism diagnosis
- Minimum improvement of symptoms required from group assignment: approximately 2 point CGI severity of illness change (or equivalent) based on PDN impression of change in illness severity from initial diagnosis (estimated based on review of past medical records) and current functioning
- OR
- Current assessment of functional impairment due to autism symptoms using a standardized assessment measure such as the Developmental Disability-Children s Global Assessment Scale will reflect adequate functioning in all areas and/or a clinically significant improvement in functioning, consistent with common psychiatric treatment definitions for treatment response
- Able to participate in study procedures.
- AUTISM Group:
- Diagnosis of autism following the same criteria as described above
- Treatment history: all study participants must have received adequate treatment intervention. Treatment history will be matched to treatment provided to children in the REM-AUT group.
- Screening visit (after meeting initial eligibility): will meet criteria for autistic disorder using the same diagnostic process described for the REM-AUT group above
- Matched to REM-AUT group on IQ, age of diagnosis, and treatment history. IQ matching between the AUT and REM-AUT groups will be based on pretreatment estimates of cognitive level obtained from the medical record review.
- Able to participate in study procedures.
- TD Group:
- IQ matched to a sub-sample of children in the REM-AUT group with normal range intellectual functioning. IQ matching between the TD and REM-AUT groups will be based on current intellectual functioning at the time of study participation.
- Able to participate in study procedures.
Who cannot join
- All groups: May not be pregnant or have a known genetic disorder, mitochondrial disease, history of birth trauma, or current uncontrolled seizures
- TD Group:
- Current diagnosis or significant history of pervasive developmental disorder, language delay or disorder (except articulation), attention or learning issues, or major psychiatric condition.
- Prematurity at birth less than 36 weeks gestation); or birth weight significantly below normal for gestational age (SGA- small for gestational age).
- PARENTS OF ALL STUDY PARTICIPANTS:
- As noted parents of all study groups will provide DNA, plasma, and serum samples.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Characterization of Autism Spectrum Disorder in School Aged Children
Autism is defined as a lifelong pervasive developmental disability, as such, symptom recovery is considered rare. Reports by Lovaas and McEachin, Smith \& Lovaas and more recently by Cohen, Amerine-Dickens, \& Smith, Smith Groen et al. and Sutera Pandey et al suggest that intensive behavioral intervention programs during preschool years may result in improvement to the point where some children no longer meet criteria for autism by the time they reach school age. Similarly, there are a large number of anecdotal reports of children with autism who, following intensive biomedical intervention (e.g., gluten/casein free diets, vitamin supplements, chelation), are indistinguishable from their typically developing peers. The goal of the current research is to characterize the behavioral and biological profiles of children with autism who show significant symptom reduction such that they no longer meet criteria for autism (Remitted Autism [REM-AUT]) and to contrast them with a group of children who continue to meet criteria for autism (AUT) and to typically developing (TD) group of children. Examining whether neurobiological and neurobehavioral symptoms commonly reported in autism are as frequent and severe in children who have responded to treatment is an important first step in determining what factors may contribute to symptom remission in autism. In addition, understanding how children with remitted autism compare to typically developing children will help us better understand whether symptom improvement is through remediation (normalization of function) or compensation (achieving the same behavioral/adaptive outcome but through an alternative process).
Read the detailed description
Autism is defined as a lifelong pervasive developmental disability, as such, symptom recovery is considered rare. Reports by Lovaas and McEachin, Smith \& Lovaas and more recently by Cohen, Amerine-Dickens, \& Smith, Smith Groen et al. and Sutera Pandey et al suggest that intensive behavioral intervention programs during preschool years may result in improvement to the point where some children no longer meet criteria for autism by the time they reach school age. Similarly, there are a large number of anecdotal reports of children with autism who, following intensive biomedical intervention (e.g., gluten/casein free diets, vitamin supplements, chelation), are indistinguishable from their typically developing peers. The goal of the current research is to characterize the behavioral and biological profiles of children with autism who show significant symptom reduction such that they no longer meet criteria for autism (Remitted Autism [REM-AUT]) and to contrast them with a group of children who continue to meet criteria for autism (AUT) and to typically developing (TD) group of children. Examining whether neurobiological and neurobehavioral symptoms commonly reported in autism are as frequent and severe in children who have responded to treatment is an important first step in determining what factors may contribute to symptom remission in autism. In addition, understanding how children with remitted autism compare to typically developing children will help us better understand whether symptom improvement is through remediation (normalization of function) or compensation (achieving the same behavioral/adaptive outcome but through an alternative process).
- Conditions
- Autism Spectrum Disorders, Autism
- Keywords
- Outcome, Autism, Pervasive Developmental Disorder
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Child Development Disorders, Pervasive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study start25 Jun 2009
- Study completion9 Oct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The 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
- Observational
- Time perspective
- Other
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Susan E Swedo, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00938054
- Sponsor's protocol ID
- 090171
- Other IDs
- 09-M-0171
- Status last verified
- 9 Oct 2012
- First submitted
- 10 Jul 2009
- Last updated
- 6 Oct 2017
- Results posted
- No
Publications
Abrahams BS, Geschwind DH. Advances in autism genetics: on the threshold of a new neurobiology. Nat Rev Genet. 2008 May;9(5):341-55. doi: 10.1038/nrg2346.
PubMed 18414403Bibby P, Eikeseth S, Martin NT, Mudford OC, Reeves D. Progress and outcomes for children with autism receiving parent-managed intensive interventions. Res Dev Disabil. 2002 Jan-Feb;23(1):81-104. doi: 10.1016/s0891-4222(02)00095-1.
PubMed 12071397Boyd RD, Corley MJ. Outcome survey of early intensive behavioral intervention for young children with autism in a community setting. Autism. 2001 Dec;5(4):430-41. doi: 10.1177/1362361301005004007.
PubMed 11777258
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Autism Spectrum Disorder in School Aged Children
- ClinicalTrials.gov ID
- NCT00938054
- Acronym / sponsor ID
- 090171
- Conditions
- Autism Spectrum Disorders, Autism
- Keywords
- Outcome, Autism, Pervasive Developmental Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 25 Jun 2009
- Study completion
- 9 Oct 2012
- First posted
- 13 Jul 2009 (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.
Autism is defined as a lifelong pervasive developmental disability, as such, symptom recovery is considered rare. Reports by Lovaas and McEachin, Smith \& Lovaas and more recently by Cohen, Amerine-Dickens, \& Smith, Smith Groen et al. and Sutera Pandey et al suggest that intensive behavioral intervention programs during preschool years may result in improvement to the point where some children no longer meet criteria for autism by the time they reach school age. Similarly, there are a large number of anecdotal reports of children with autism who, following intensive biomedical intervention (e.g., gluten/casein free diets, vitamin supplements, chelation), are indistinguishable from their typically developing peers. The goal of the current research is to characterize the behavioral and biological profiles of children with autism who show significant symptom reduction such that they no longer meet criteria for autism (Remitted Autism [REM-AUT]) and to contrast them with a group of children who continue to meet criteria for autism (AUT) and to typically developing (TD) group of children. Examining whether neurobiological and neurobehavioral symptoms commonly reported in autism are as frequent and severe in children who have responded to treatment is an important first step in determining what factors may contribute to symptom remission in autism. In addition, understanding how children with remitted autism compare to typically developing children will help us better understand whether symptom improvement is through remediation (normalization of function) or compensation (achieving the same behavioral/adaptive outcome but through an alternative process).
Detailed description
Autism is defined as a lifelong pervasive developmental disability, as such, symptom recovery is considered rare. Reports by Lovaas and McEachin, Smith \& Lovaas and more recently by Cohen, Amerine-Dickens, \& Smith, Smith Groen et al. and Sutera Pandey et al suggest that intensive behavioral intervention programs during preschool years may result in improvement to the point where some children no longer meet criteria for autism by the time they reach school age. Similarly, there are a large number of anecdotal reports of children with autism who, following intensive biomedical intervention (e.g., gluten/casein free diets, vitamin supplements, chelation), are indistinguishable from their typically developing peers. The goal of the current research is to characterize the behavioral and biological profiles of children with autism who show significant symptom reduction such that they no longer meet criteria for autism (Remitted Autism [REM-AUT]) and to contrast them with a group of children who continue to meet criteria for autism (AUT) and to typically developing (TD) group of children. Examining whether neurobiological and neurobehavioral symptoms commonly reported in autism are as frequent and severe in children who have responded to treatment is an important first step in determining what factors may contribute to symptom remission in autism. In addition, understanding how children with remitted autism compare to typically developing children will help us better understand whether symptom improvement is through remediation (normalization of function) or compensation (achieving the same behavioral/adaptive outcome but through an alternative process).
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (31 listed)
- Diagnosis of autism prior to symptom improvement
- OR
- AND
- Current functioning:
- At screening visit (after meeting initial eligibility), will not meet criteria for autism
Key exclusion criteria (6 listed)
- All groups: May not be pregnant or have a known genetic disorder, mitochondrial disease, history of birth trauma, or current uncontrolled seizures
- Current diagnosis or significant history of pervasive developmental disorder, language delay or disorder (except articulation), attention or learning issues, or major psychiatric condition.
- Prematurity at birth less than 36 weeks gestation); or birth weight significantly below normal for gestational age (SGA- small for gestational age).
- As noted parents of all study groups will provide DNA, plasma, and serum samples.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 6 Oct 2017.
- Background: PubMed 18414403Abrahams BS, Geschwind DH. Advances in autism genetics: on the threshold of a new neurobiology. Nat Rev Genet. 2008 May;9(5):341-55. doi: 10.1038/nrg2346.
- Background: PubMed 12071397Bibby P, Eikeseth S, Martin NT, Mudford OC, Reeves D. Progress and outcomes for children with autism receiving parent-managed intensive interventions. Res Dev Disabil. 2002 Jan-Feb;23(1):81-104. doi: 10.1016/s0891-4222(02)00095-1.
- Background: PubMed 11777258Boyd RD, Corley MJ. Outcome survey of early intensive behavioral intervention for young children with autism in a community setting. Autism. 2001 Dec;5(4):430-41. doi: 10.1177/1362361301005004007.
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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.
Susan E Swedo, M.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorders and Autism, run by National Institute of Mental Health (NIMH) 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 31 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 6 Oct 2017. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00938054, which also lists 3 linked publications.
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 6 Oct 2017.