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

This study is currently recruiting participants.
Verified February 2013 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
alan apter, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00445471
First received: March 8, 2007
Last updated: February 6, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention
Child Development Disorders, Pervasive
 Behavioral: Mifne Approach to PDD
Behavioral: Treatment as usual

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • ADOS scores at 3 and 6 months after commencement of treatment [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CGI-I score after 3 and 6 months [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: April 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A
Mifne Approach to PDD
 Behavioral: Mifne Approach to PDD
B
Treatment as usual
 Behavioral: Treatment as usual

  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445471

Contacts
Contact: Alan Apter, MD eapter@clalit.org.il

Locations
Israel
Schneider Children's Medical Center of Israel, Departemnt of Psychological Medicine Recruiting
Petach Tikva, Israel
Contact: Alan Apter, MD         eapter@clalit.org.il    
Principal Investigator: Alan Apter, MD            
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

No publications provided

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
Study First Received: March 8, 2007
Last Updated: February 6, 2013
Health Authority: Israel: Ethics Commission

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

Additional relevant MeSH terms:
Developmental Disabilities
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013