Back to results

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

Primary Purpose

Autism, Asperger Syndrome

Status

Completed

Phase

Phase 1

Locations

Brazil

Study Type

Interventional

Intervention

Speech Therapy

About this trial

This is an interventional treatment trial for Autism focused on measuring Autism, Asperger Syndrome

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Others clinical diagnosis

Sites / Locations

Ana Carina Tamanaha

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm Description

Speech therapy

Outcomes

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00725556

First Posted

July 28, 2008

Last Updated

July 31, 2008

Sponsor

Federal University of São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT00725556

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2008

Overall Recruitment Status

Completed

Study Start Date

March 2006 (undefined)

Primary Completion Date

March 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Federal University of São Paulo

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism, Asperger Syndrome

Keywords

Autism, Asperger Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Non-Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Other

Arm Description

Speech therapy

Intervention Type

Other

Intervention Name(s)

Speech Therapy

Intervention Description

Speech Therapy

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical diagnosis of Autism or Asperger Syndrome Age (children) Adherence in the study (at least 70%) Exclusion Criteria: Others clinical diagnosis

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ana Carina Tamanaha, Student

Organizational Affiliation

Federal University of São Paulo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ana Carina Tamanaha

City

São Paulo

ZIP/Postal Code

04358030

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs