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

Sponsor

Rabin Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT00445471

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Child Development Disorders, Pervasive	Behavioral: Mifne Approach to PDD Behavioral: Treatment as usual	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Apr 1, 2007

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: A Mifne Approach to PDD	Behavioral: Mifne Approach to PDD
Other: B Treatment as usual	Behavioral: Treatment as usual

Arm

Intervention/Treatment

Other: A

Mifne Approach to PDD

Behavioral: Mifne Approach to PDD

Other: B

Treatment as usual

Behavioral: Treatment as usual

Outcome Measures

Primary Outcome Measures

ADOS scores at 3 and 6 months after commencement of treatment [2.5 years]

Secondary Outcome Measures

CGI-I score after 3 and 6 months [2.5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 5 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Schneider Children's Medical Center of Israel, Departemnt of Psychological Medicine	Petach Tikva		Israel

Sponsors and Collaborators

Rabin Medical Center

Investigators

Principal Investigator: Alan Apter, MD, Director Department of Psychological Medicine Schneider Children's Medical Center of Israel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT00445471

Other Study ID Numbers:

4222

First Posted:

Mar 9, 2007

Last Update Posted:

Dec 25, 2014

Last Verified:

Dec 1, 2014

Keywords provided by alan apter, Director, Feinberg Child Study Center and Department of Psychiatry, Schneider's Children's Medical Center of Israel, Rabin Medical Center

Autism Spectrum Disorder

Autistic Disorder

Pervasive Developmental Disorder

Additional relevant MeSH terms:

Developmental Disabilities

Child Development Disorders, Pervasive

Study Results

No Results Posted as of Dec 25, 2014