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A Prospective Study Comparing the Mifne Approach of Treating Childhood Autism With Routine Standard Treatment

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ClinicalTrials.gov Identifier: NCT00445471
Recruitment Status : Terminated (Mifne began treating younger patients who could not be diagnosed with the ADOS used in the study)
First Posted : March 9, 2007
Last Update Posted : December 25, 2014
Sponsor:
Information provided by (Responsible Party):
alan apter, Rabin Medical Center

March 8, 2007
March 9, 2007
December 25, 2014
April 2007
December 2012   (Final data collection date for primary outcome measure)
ADOS scores at 3 and 6 months after commencement of treatment [ Time Frame: 2.5 years ]
  • Score on ADOS-G items at 3 and 6 months after commencement of treatment
  • CGI-I score at 3 and 6 months after commencement of treatment
Complete list of historical versions of study NCT00445471 on ClinicalTrials.gov Archive Site
CGI-I score after 3 and 6 months [ Time Frame: 2.5 years ]
Not Provided
Not Provided
Not Provided
 
A Prospective Study Comparing the Mifne Approach of Treating Childhood Autism With Routine Standard Treatment
Not Provided
The current study aims at comparing outcomes achieved using the Mifne approach of treating autistic children with results obtained when routine standard treatment is used. A prospective comparative study will be performed comparing the results of 12 children treated at Mifne with 12 children treated with treatment as usual. A child and adolescent psychiatrist using the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule-Generic (ADOS-G) will make the diagnostic assessment and a developmental psychologist will make the developmental and psychological assessments using the Vineland Adaptive Behavior Scales-Revised and the Bayley Scales of Infant Development (BSID II) before the child enters the study. Each child will be reassessed following completion of the Mifne intervention, at three and at six months after commencement of treatment. The control child will also be reassessed at three and at six months after commencement of a therapeutic intervention.
Not Provided
Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Child Development Disorders, Pervasive
  • Behavioral: Mifne Approach to PDD
  • Behavioral: Treatment as usual
  • A
    Mifne Approach to PDD
    Intervention: Behavioral: Mifne Approach to PDD
  • B
    Treatment as usual
    Intervention: Behavioral: Treatment as usual
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
45
24
December 2012
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • All children between the ages of 2-5 years who meet diagnostic criteria for Autism or Pervasive Developmental Disorder by DSM IV criteria who are referred for treatment at Mifne for the treatment group.
  • The control group will consist of children meeting the same criteria who are referred to Schneider Children's Medical Center of Israel (SCMCI). Matching will be for age, sex, ethnicity, socioeconomic status, IQ, language development and diagnosis.

Exclusion criteria:

  • All referred children who do not meet criteria for Autism or PDD or do not understand Hebrew.
Sexes Eligible for Study: All
2 Years to 5 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00445471
4222
No
Not Provided
Not Provided
alan apter, Rabin Medical Center
Rabin Medical Center
Not Provided
Principal Investigator: Alan Apter, MD Director Department of Psychological Medicine Schneider Children's Medical Center of Israel
Rabin Medical Center
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP