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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00445471

Enrollment

Registered

2007-03-09

Start date

2007-04-30

Completion date

2012-12-31

Last updated

2014-12-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Development Disorders, Pervasive

Keywords

Autism Spectrum Disorder, Autistic Disorder, Pervasive Developmental Disorder

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.

Interventions

BEHAVIORALMifne Approach to PDD

BEHAVIORALTreatment as usual

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 5 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
ADOS scores at 3 and 6 months after commencement of treatment	2.5 years

Secondary

Measure	Time frame
CGI-I score after 3 and 6 months	2.5 years

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026