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

Study Overview
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Brief Summary
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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.

Conditions
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Child Development Disorders, Pervasive

Intervention / Treatment
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* Behavioral: Mifne Approach to PDD
* Behavioral: Treatment as usual


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br>Mifne Approach to PDD | Behavioral: Mifne Approach to PDD<br> <br> |
| Other: B<br>Treatment as usual | Behavioral: Treatment as usual<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADOS scores at 3 and 6 months after commencement of treatment |  | 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI-I score after 3 and 6 months |  | 2.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism Spectrum Disorder, Autistic Disorder, Pervasive Developmental Disorder