- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00445471
A Prospective Study Comparing the Mifne Approach of Treating Childhood Autism With Routine Standard Treatment
December 24, 2014 updated by: alan apter, Rabin Medical Center
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Petach Tikva, Israel
- Schneider Children's Medical Center of Israel, Departemnt of Psychological Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: A
Mifne Approach to PDD
|
|
Other: B
Treatment as usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ADOS scores at 3 and 6 months after commencement of treatment
Time Frame: 2.5 years
|
2.5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
CGI-I score after 3 and 6 months
Time Frame: 2.5 years
|
2.5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alan Apter, MD, Director Department of Psychological Medicine Schneider Children's Medical Center of Israel
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
March 8, 2007
First Submitted That Met QC Criteria
March 8, 2007
First Posted (Estimate)
March 9, 2007
Study Record Updates
Last Update Posted (Estimate)
December 25, 2014
Last Update Submitted That Met QC Criteria
December 24, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4222
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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