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

NCT ID: NCT00445471

Last Updated: 2014-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2012-12-31

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.

Detailed Description

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Conditions

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Child Development Disorders, Pervasive

Keywords

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Autism Spectrum Disorder Autistic Disorder Pervasive Developmental Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Mifne Approach to PDD

Group Type OTHER

Mifne Approach to PDD

Intervention Type BEHAVIORAL

B

Treatment as usual

Group Type OTHER

Treatment as usual

Intervention Type BEHAVIORAL

Interventions

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Mifne Approach to PDD

Intervention Type BEHAVIORAL

Treatment as usual

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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alan apter

Director, Feinberg Child Study Center and Department of Psychiatry, Schneider's Children's Medical Center of Israel

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alan Apter, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Petah Tikva, , Israel

Site Status

Countries

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Israel

Other Identifiers

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4222

Identifier Type: -

Identifier Source: org_study_id