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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):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Child Development Disorders, Pervasive Behavioral: Mifne Approach to PDD Behavioral: Treatment as usual

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2007
Primary Completion Date : December 2012
Study Completion Date : December 2012
Arms and Interventions

Arm Intervention/treatment
A
Mifne Approach to PDD
Behavioral: Mifne Approach to PDD
B
Treatment as usual
Behavioral: Treatment as usual


Outcome Measures

Primary Outcome Measures :
  1. ADOS scores at 3 and 6 months after commencement of treatment [ Time Frame: 2.5 years ]

Secondary Outcome Measures :
  1. CGI-I score after 3 and 6 months [ Time Frame: 2.5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445471


Locations
Israel
Schneider Children's Medical Center of Israel, Departemnt of Psychological Medicine
Petach Tikva, Israel
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Alan Apter, MD Director Department of Psychological Medicine Schneider Children's Medical Center of Israel
More Information

Responsible Party: alan apter, Director, Feinberg Child Study Center and Department of Psychiatry, Schneider's Children's Medical Center of Israel, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT00445471     History of Changes
Other Study ID Numbers: 4222
First Posted: March 9, 2007    Key Record Dates
Last Update Posted: December 25, 2014
Last Verified: December 2014

Keywords provided by alan apter, Rabin Medical Center:
Autism Spectrum Disorder
Autistic Disorder
Pervasive Developmental Disorder

Additional relevant MeSH terms:
Developmental Disabilities
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders