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

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00725556
First received: July 28, 2008
Last updated: July 31, 2008
Last verified: July 2008
History of Changes
  Purpose
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 Intervention Phase
Autism
Asperger Syndrome
 Other: Speech Therapy
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Development of Autistic Children Based on Mother´s Response in Autism Behavior Checklist

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
Enrollment: 11
Study Start Date: March 2006
Study Completion Date: December 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Speech therapy
 Other: Speech Therapy
Speech Therapy

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.

  Eligibility
Ages Eligible for Study:   3 Years to 12 Years   (Child)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Responsible Party: Ana Carina Tamanaha, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT00725556     History of Changes
Other Study ID Numbers: Ana Carina Tamanaha 
Study First Received: July 28, 2008
Last Updated: July 31, 2008
Health Authority: Brazil: Ethics Committee

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

ClinicalTrials.gov processed this record on September 23, 2016