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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
alan apter, Rabin Medical Center

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 Phase
Child Development Disorders, Pervasive Behavioral: Mifne Approach to PDD Behavioral: Treatment as usual Not Applicable

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
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

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

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.

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 identifier (NCT number): NCT00445471

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

Responsible Party: alan apter, Director, Feinberg Child Study Center and Department of Psychiatry, Schneider's Children's Medical Center of Israel, Rabin Medical Center 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