Back to resultsA Prospective Study Comparing the Mifne Approach of Treating Childhood Autism With Routine Standard Treatment
Primary Purpose
Child Development Disorders, Pervasive
Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Mifne Approach to PDD
Treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Child Development Disorders, Pervasive focused on measuring Autism Spectrum Disorder, Autistic Disorder, Pervasive Developmental Disorder
Eligibility 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.
Sites / Locations
- Schneider Children's Medical Center of Israel, Departemnt of Psychological Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
A
B
Arm Description
Mifne Approach to PDD
Treatment as usual
Outcomes
Primary Outcome Measures
ADOS scores at 3 and 6 months after commencement of treatment
Secondary Outcome Measures
CGI-I score after 3 and 6 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00445471
Brief Title
A Prospective Study Comparing the Mifne Approach of Treating Childhood Autism With Routine Standard Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
Mifne began treating younger patients who could not be diagnosed with the ADOS used in the study
Study Start Date
April 2007 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Development Disorders, Pervasive
Keywords
Autism Spectrum Disorder, Autistic Disorder, Pervasive Developmental Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Other
Arm Description
Mifne Approach to PDD
Arm Title
B
Arm Type
Other
Arm Description
Treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Mifne Approach to PDD
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Primary Outcome Measure Information:
Title
ADOS scores at 3 and 6 months after commencement of treatment
Time Frame
2.5 years
Secondary Outcome Measure Information:
Title
CGI-I score after 3 and 6 months
Time Frame
2.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Apter, MD
Organizational Affiliation
Director Department of Psychological Medicine Schneider Children's Medical Center of Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schneider Children's Medical Center of Israel, Departemnt of Psychological Medicine
City
Petach Tikva
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
A Prospective Study Comparing the Mifne Approach of Treating Childhood Autism With Routine Standard Treatment
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