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

Autism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725556
• Other study ID #: Ana Carina Tamanaha
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 28, 2008
• Last updated: July 31, 2008
• Start date: March 2006
• Est. completion date: December 2007

Study information

• Verified date: July 2008
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 12 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Autism or Asperger Syndrome

• Age (children)

• Adherence in the study (at least 70%)

Exclusion Criteria:

• Others clinical diagnosis

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asperger Syndrome
• Autism
• Autistic Disorder

Intervention

Other:
• Speech Therapy
Speech Therapy

Locations

Country	Name	City	State
Brazil	Ana Carina Tamanaha	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the process of development of autistic children, in a direct and indirect intervention context from mother´s response in Autism Behavior Checklist.		one year	No