A Study of a Developmental,Individual-Difference,Relationship-Bases/Floortime Intervention for Children With Autistic

NCT ID: NCT00954213

Last Updated: 2010-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-06-30

Brief Summary

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Thirty eight autistic spectrum disorder children age 2-6 years recruited into the study. The new treatment intervention is based on the DIR Model. Parents will be coached at the start and then every 3-4 months for 1 year. Outcome will be measured at the first session and at the end of the study using Functional Emotional Assessment Scale and Childhood Autism Rating Scales, Functional Emotional Level, and parent satisfaction rating.

Hypothesis of the study: Children who get additional treatment of DIR/floortime show much improvement in climbing the developmental "ladder" and declining in the autistic behaviors.

Detailed Description

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Conditions

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Autism Spectrum Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DIR/Floortime parent intervention

Group Type EXPERIMENTAL

DIR/Floortime parent intervention

Intervention Type BEHAVIORAL

Parent will be trained to observe their autistic child's cues, follow their child's lead and techniques to enhance his/her development.

Interventions

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DIR/Floortime parent intervention

Parent will be trained to observe their autistic child's cues, follow their child's lead and techniques to enhance his/her development.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* clinical criteria for Autistic Disorders according to DSM IV
* child is 2 - 6 years of age

Exclusion Criteria

* children with additional medical diagnosis (e.g., genetic syndromes, diagnosed hearing impairment, diagnosed visual impairment or seizures)
* children who are geographically inaccessible for follow-up visits
* their parents are not literate or known chronic psychiatric or physical illness in the parents
Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Rehabilitation Medicine, Siriraj Hospital, Bangkok, Thailand

Principal Investigators

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Kingkaew Pajareya, MD

Role: PRINCIPAL_INVESTIGATOR

Rehabilitation Medicine, Siriraj Hospital, Bangkok, Thailand

Locations

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Kingkaew Pajareya

Bangkoknoi, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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206/2551(EC1)

Identifier Type: -

Identifier Source: org_study_id

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