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

Not Applicable

Terminated

• Conditions: Child Development Disorders, Pervasive
• Interventions: Behavioral: Treatment as usual; Behavioral: Mifne Approach to PDD

• Registration Number: NCT00445471
• Lead Sponsor: Rabin Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-03-08
• Study First Submitted QC: 2007-03-08
• Study First Posted: 2007-03-09
• Study Start: 2007-04
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-24
• Last Update Posted: 2014-12-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Treatment as usual	Treatment as usual
A	Mifne Approach to PDD	Mifne Approach to PDD

Primary Outcome Measures

Name	Time	Method
ADOS scores at 3 and 6 months after commencement of treatment	2.5 years

Secondary Outcome Measures

Name	Time	Method
CGI-I score after 3 and 6 months	2.5 years

Trial Locations

Locations (1)

Schneider Children's Medical Center of Israel, Departemnt of Psychological Medicine; 🇮🇱 Petach Tikva, Israel