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The Development of Autistic Children Based on Mothers´Response in Autism Behavior Checklist

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ClinicalTrials.gov Identifier: NCT00725556
Recruitment Status : Completed
First Posted : July 30, 2008
Last Update Posted : August 1, 2008
Sponsor:
Information provided by:
Federal University of São Paulo

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to evaluate the process of development of autistic children, in a direct and indirect intervention context from mother´s response in Autism Behavior Checklist.

Condition or disease Intervention/treatment Phase
Autism Asperger Syndrome Other: Speech Therapy Phase 1 Phase 2

Detailed Description:

Aim: We evaluated the process of development of autistic children, in a direct and indirect intervention context from mother´s response in Autism Behavior Checklist.

Method:

The sample were composed of 11 mothers of children diagnosed with Autism (6) and Asperger Syndrome (5), according to the criteria established by the DSM IVtr (APA, 2002). These children were randomly divided into two groups: Six were receiving both direct and indirect intervention (Therapy Group -TG), and five were receiving exclusively indirect intervention (Orientation Group - OG). We used the Autism Behavior Checklist (Krug et al., 1993), adapted to Portuguese on three occasions: at the beginning, six months later and 12 months later. This is a list of nonadaptive behaviors (57), in the areas: Sensorial, Body and Object Use, Language, Social and Relating.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Development of Autistic Children Based on Mother´s Response in Autism Behavior Checklist
Study Start Date : March 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : December 2007

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
1
Speech therapy
 Other: Speech Therapy
Speech Therapy


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the process of development of autistic children, in a direct and indirect intervention context from mother´s response in Autism Behavior Checklist. [ Time Frame: one year ]

Eligibility Criteria
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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Autism or Asperger Syndrome
  • Age (children)
  • Adherence in the study (at least 70%)

Exclusion Criteria:

  • Others clinical diagnosis
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00725556


Locations
Brazil
Ana Carina Tamanaha
São Paulo, Brazil, 04358030
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Ana Carina Tamanaha, Student Federal University of São Paulo
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Ana Carina Tamanaha, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT00725556     History of Changes
Other Study ID Numbers: Ana Carina Tamanaha
First Posted: July 30, 2008    Key Record Dates
Last Update Posted: August 1, 2008
Last Verified: July 2008

Keywords provided by Federal University of São Paulo:
Autism
Asperger Syndrome

Additional relevant MeSH terms:
Autistic Disorder
Asperger Syndrome
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders