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

This study has been terminated.

(Mifne began treating younger patients who could not be diagnosed with the ADOS used in the study)

Sponsor:

Information provided by (Responsible Party):

alan apter, Rabin Medical Center

ClinicalTrials.gov Identifier:

NCT00445471

First received: March 8, 2007

Last updated: December 24, 2014

Last verified: December 2014

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:

MedlinePlus related topics: Developmental Disabilities

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 ]


Enrollment:	45
Study Start Date:	April 2007
Study Completion Date:	December 2012
Primary Completion Date:	December 2012 (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 (Child)
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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	March 8, 2007
Last Updated:	December 24, 2014
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 Neurodevelopmental Disorders Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2016

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