NIH to study recovered autistics

10 Mar

A clinical trial has been started to study and compare autistics (children to young adults) who have “remitted” autism. These are people who would be called “recovered” by the autism parent community.

The trial can be found on clinicaltrials.gov The purpose of the trial is given as:

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)

Three groups will be compared: “remitted autism” (REM-AUT), “autism” (AUTISM) and “typically developing” (TD).

The inclusion criteria are given below. As you can imagine, the criteria are extensive for the “remitted” group.

Remitted Autism (REM-AUT) Group:

1. Diagnosis of autism prior to symptom improvement
1. valid administration of ADI and/or ADOS with accompanying interpretive report yielding an autism diagnosis
OR
2. 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
3. measure of cognitive ability from within 1 year of initial autism diagnosis
4. 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
5. initial diagnosis of autism prior to age 6
AND
6. 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
7. The final decision for meeting diagnostic and treatment history inclusion criteria is based on PDN branch staff review of the case
8. 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

2. Current functioning:

a. Parent report and report of at least one professional that child is no longer autistic

3. At screening visit (after meeting initial eligibility), will not meet criteria for autism
1. 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.
2. Teacher/informant report of autism symptoms (such as results from the SRS) not indicative of autism diagnosis
3. 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
4. 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

4. Able to participate in study procedures.

AUTISM Group:

1. Diagnosis of autism following the same criteria as described above
2. 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.
3. Screening visit (after meeting initial eligibility): will meet criteria for autistic disorder using the same diagnostic process described for the REM-AUT group above
4. 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.
5. Able to participate in study procedures.

TD Group:

1. 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.
2. Able to participate in study procedures.

EXCLUSION CRITERIA:

All groups: May not be pregnant or have a known genetic disorder, mitochondrial disease, history of birth trauma, or current uncontrolled seizures

TD Group:

1. Current diagnosis or significant history of pervasive developmental disorder, language delay or disorder (except articulation), attention or learning issues, or major psychiatric condition.
2. Prematurity at birth less than 36 weeks gestation); or birth weight significantly below normal for gestational age (SGA- small for gestational age).

This is a study that should be done, in my opinion. I will note that this study has supposedly been one of the key pieces being sought by multiple parent groups. I will further note that I have not seen any of them mention this study. Quite the opposite, in fact. I see comments occasionally on blogs about how their frustration that such a study is not being performed. Perhaps I missed it, but I am curious why their leadership doesn’t make a big deal out of this.

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16 Responses to “NIH to study recovered autistics”

  1. Corina Becker March 10, 2010 at 01:40 #

    Personally, I think it will be very interesting to see the results of this study.

  2. passionlessDrone March 10, 2010 at 02:08 #

    Hi Sullivan –

    In my group of parent friends, I believe there are two children who have lost their diagnosis of autism all together. There may be one or two more that went from autism to PDD-NOS or Aspergers. I will forward them this information. Tragically, I cannot (yet) enroll my son. Upwards and onwards.

    Thank you for posting this.

    - pD

  3. Ian MacGregor March 10, 2010 at 03:27 #

    PD, as I read the study requirements they also want to look at children who have had similar treatments but remain autistic.

  4. Science Mom March 10, 2010 at 03:36 #

    The inclusion criteria read to me that they will accept children that have underwent ‘biomed’. Am I correct with that interpretation? In any event, this is an important study and great catch Sullivan.

  5. Laurentius Rex March 10, 2010 at 11:25 #

    Whilst interesting perhaps as an essay in the sociology of medicine I am afraid that such a study would fail all the tests of a rigid Popperian science in that like faith it is a study based upon an unverifiable hypothesis.

    That is to say it is one of Wittgensteins language games in that the notion is predicated upon how one defines autism at any one time, and that recovery is wholly dependent upon refining the categories across an age range. I cannot see, given that there are as yet no bio-markers for autism any wider validity at all.

    It is essentially like defining recovery from epilepsy by observing people whose epilepsy is controlled by medication. You won’t see it, (by the same tokens that even the so called gold standards of autism measure the phenomenon) but it is still there.

    Heck if I walk into a room, shake hands politely with a physician, fake eye contact, sit down, make my excuses and then depart, you won’t have measured autism or anything else unless you apply surmise and pseudo science to come up with your conclusion whatever that might be.

    Larry

  6. Mekei March 10, 2010 at 12:59 #

    I’ve got a set of fraternal twins that would fit nicely into the AUT and TD groups, respectively.

    @Ian – good point!

  7. Broken Link March 10, 2010 at 13:38 #

    Actually, Sullivan, this study has been advertised on many autism biomed yahoo groups, for example:

    http://health.groups.yahoo.com/group/Autism-Mercury/message/264588

    IIRC, the only responses were silence, or people who wished they could participate – if their child were recovered, rather than recovering.

    I think this is a very interesting study, but my prediction is that they will be unable to find enough children who qualify for the REM-AUT group.

    • Sullivan March 10, 2010 at 19:06 #

      Broken Link,

      thanks for that information. I missed that. Interestingly, the recruitment started over 6 months ago. I would think that Lyn Redwood and Mark Blaxill, members of SafeMinds and participants in the IACC would be making great publicity out of this. I would think that the IACC watchers on the Age of Autism blog would make a big deal out of this. Here is a fragment of a recent comment (Jan 2010) on AoA, in response to a post highly critical of the IACC:

      “‘Here’s a thought Dr. Rice, if you haven’t been able to find the “origin” of autism – why not try it the other way? Go to the recovered children’s families and ask – What the heck did you do to help your child?”

      Did anyone correct this person? Did the blogger actually inform this person that the study was already underway?

      When it comes to issues like the truth that the budgets recommended by the IACC are heavily weighted towards environmental causation and the fact that the “remitted” autism study is ongoing, I’m covering it. Blogs like the Age of Autism are silent on these issues, letting their readership think that the IACC ignores their wishes.

      The groups with a focus on vaccines tend to push the concept of “biomedical recovery” and “environmental causation”, but they don’t seem to care when the studies they supposedly called for are actually funded.

      • Sullivan March 10, 2010 at 19:15 #

        Broken Link,

        I forgot to add–part of my frustration comes from a recent blog post by Jenny McCarthy on the Huffington Post (discussed in detail by Orac). She’s on the board of Generation Rescue, and probably the most well known spokesperson for the cause of a whole cluster of organizations. In her piece she makes the comment:

        Most doctors in our community share a common trait: their own child regressed into autism. They fixed their kid first and knew they’d have to spend their lives helping parents do the same, accepting the loss of “mainstream” status in their field.

        Who’s afraid of autism recovery? Perhaps it’s the diagnosticians and pediatricians who have made a career out of telling parents autism is a hopeless condition.

        Besides the fact that most DAN doctors I’ve read about have not recovered their kids, she seems to be pushing the same tactic–no one is concerned about “recovered” kids. One wonders whether Ms. McCarthy is ignorant of the facts or if she and her orgs are “afraid” of what will happen as the ideas of improving the wellbeing of autistics is separated from the “vaccine injury” message.

  8. Broken Link March 10, 2010 at 13:41 #

    And yet another posting where Lori Knowles appears to be really trying hard to find those other recovered kids:

    http://health.groups.yahoo.com/group/Autism-Mercury/message/272626

  9. Ian MacGregor March 10, 2010 at 15:01 #

    Everyone has jumped on the biomedical part of the study. They also want to include children who have had behavioral treatments which I imagine is ABA.

  10. Broken Link March 11, 2010 at 02:27 #

    Thanks for the comments, Sullivan. I agree that it is clear that if there were thousands (even hundreds) of recovered autistic kids, they’d be flocking to the study.

    I’d encourage your readers to have a look at this ABC news article. There, parents are claiming recovery. Let them know about this study.

    http://abcnews.go.com/Health/TheLaw/doctors-sued-autism-chelation-therapy/story?id=10045951

  11. daedalus2u March 15, 2010 at 19:40 #

    I think they should also look at the cohort of children who had a temporary reduction in autism symptoms with fever.

    http://www.ncbi.nlm.nih.gov/pubmed/18055656

    A temporary acute reduction implies that the reduction is due to acute regulation and not changes in neuroanatomy.

    I have a long post on my blog as to what I think the physiology of that change in acute regulation is.

  12. Niki Johnson November 1, 2011 at 21:30 #

    Please read this I truly believe in this connection and I’m trying to tell anyone who might be open to it….I have seen the effects of acetaminophen on my autistic son and we are on our way to recovery too. Thank you, Niki

    A Hypothesis: The rise in children diagnosed with autism, across racial and socio-economic backgrounds, is attributed to the pronounced use of Acetaminophen in children from birth to age 5. The theory of vaccine causation has masked the true cause of this epidemic. Acetaminophen is the sole environmental cause of this epidemic. These children are suffering from Acetaminophen Induced Autism. When children are diagnosed with autism by the age of two or three many parents often note that while their children have passed all hearing tests they did suffer from one or even frequent ear infections as infants and babies. This is notable because infants with ear infections are often given Acetaminophen (as it is the most often recommended by nurses and physicians) for the pain and crankiness associated with the ear infections. A child that is particularly sick or feverish between birth and age 5 may be given Acetaminophen on a regular basis to treat fevers and for general comfort. Parents often do not switch to Ibuprofen since they become brand loyal to the Acetaminophen products. Parents say have been told by nurses and pediatricians to give infants and babies Acetaminophen not only after each vaccination but before a vaccination is administered to prevent a fever, whether or not it is known if a fever will result for that child. Parents have given Acetaminophen for crankiness and the assumption of pain due to teething. Many children’s cold and cough medications sold over the counter have a fever reducer (Acetaminophen) added. Parents may or may not be aware of this additional Acetaminophen being given with this medication. Parents of children diagnosed with autism often note that their children seem to have a lowered immune system (getting sick more often or for longer periods of time than their siblings) and complain that the autistic children suffer from frequent diarrhea. Parents note they have seen success with the addition of probiotics to the child’s diet. According to these parents the consumption of daily probiotics has improved immunity and resulted in normal, firm stools. Many parents of autistic children have found success with dietary changes and supplements – indicating that these dietary changes are reversing an environmental cause. This hypothesis contends that the use of Acetaminophen in infants and children through age 5 has resulted in compromised immune systems and digestive issues in addition to the cognitive and developmental delays and impairments that reveal themselves in the typical autistic characteristics – lack of verbal communication, eye contact and social engagement. Acetaminophen induced autism can be prevented. The use of Acetaminophen in infants and children through age 5 must be reviewed and severely reduced. This hypothesis suggests that Acetaminophen should only be used in this group in emergency situations and should not be available in over-the-counter form for infants and children under age 6.

    • autismepi December 20, 2013 at 20:56 #

      Your hypothesis now has support from a very well done prospective cohort study. Yet, this information is not being widely disseminated.
      Prolonged prenatal use of acetaminophen was associated with severe neurodevelopmental outcomes (all autism phenotypes) in 3 year old.

      http://www.ncbi.nlm.nih.gov/pubmed/24163279

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  1. NIH to study recovered autistics « Left Brain Right Brain | Autistic Information - September 1, 2012

    [...] Scale (SRS), Childhood Autism Rating Scale (CARS), or the … … See original here: NIH to study recovered autistics « Left Brain Right Brain ← My Aspergers Child: L-Carnosine: Nutritional Supplement for … Early Signs of [...]

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