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

NCT00445471 | Terminated

• 1 other identifier: 4222
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Development Disorders, Pervasive

Keywords

Autism Spectrum Disorder; Autistic Disorder; Pervasive Developmental Disorder

Outcome Measures

Primary Outcomes (1)

• ADOS scores at 3 and 6 months after commencement of treatment

  2.5 years

Secondary Outcomes (1)

• CGI-I score after 3 and 6 months

  2.5 years

Study Arms (2)

A

OTHER

Mifne Approach to PDD

Behavioral: Mifne Approach to PDD

B

OTHER

Treatment as usual

Behavioral: Treatment as usual

Interventions

Mifne Approach to PDD BEHAVIORAL

A

Treatment as usual BEHAVIORAL

B

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• All referred children who do not meet criteria for Autism or PDD or do not understand Hebrew.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Schneider Children's Medical Center of Israel, Departemnt of Psychological Medicine

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Alan Apter, MD

  Director Department of Psychological Medicine Schneider Children's Medical Center of Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Feinberg Child Study Center and Department of Psychiatry, Schneider's Children's Medical Center of Israel

Study Record Dates

• First Submitted: March 8, 2007
• First Posted: March 9, 2007
• Study Start: April 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 25, 2014

Record last verified: 2014-12

Locations

IL (1)