NCT00725556

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2008

Completed
Last Updated

August 1, 2008

Status Verified

July 1, 2008

Enrollment Period

1 year

First QC Date

July 28, 2008

Last Update Submit

July 31, 2008

Conditions

Keywords

AutismAsperger Syndrome

Outcome Measures

Primary Outcomes (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.

    one year

Study Arms (1)

1

OTHER

Speech therapy

Other: Speech Therapy

Interventions

Speech Therapy

1

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Others clinical diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ana Carina Tamanaha

São Paulo, São Paulo, 04358030, Brazil

Location

MeSH Terms

Conditions

Autistic DisorderAsperger Syndrome

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language DisordersRehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Ana Carina Tamanaha, Student

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 28, 2008

First Posted

July 30, 2008

Study Start

March 1, 2006

Primary Completion

March 1, 2007

Study Completion

December 1, 2007

Last Updated

August 1, 2008

Record last verified: 2008-07

Locations