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

Child Development Disorders, Pervasive Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00445471
• Other study ID #: 4222
• Status: Terminated
• Phase: N/A
• First received: March 8, 2007
• Last updated: December 24, 2014
• Start date: April 2007
• Est. completion date: December 2012

Study information

• Verified date: December 2014
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 5 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Child Development Disorders, Pervasive
• Developmental Disabilities

Intervention

Behavioral:
• Mifne Approach to PDD

• Treatment as usual

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center of Israel, Departemnt of Psychological Medicine	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADOS scores at 3 and 6 months after commencement of treatment		2.5 years	No
Secondary	CGI-I score after 3 and 6 months		2.5 years	No