A Pilot Trial of a Developmental, Individual-Difference, Relationship-Bases (DIR)/Floortime for Children With Autistic Spectrum Disorders

NCT ID: NCT00954083

Last Updated: 2009-08-06

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-04-30

Brief Summary

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Thirty two children age 2-6 years are recruited into the study and the randomization will be stratified for chronological age and symptom severity into 2 main groups, intervention and control. The intervention group will receive an additional target treatment of DIR/Floortime parent training intervention, while the control group will continue on their routine care for 3 months.

Hypothesis: Children in the intervention group 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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Autistic Spectrum Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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DIR/Floortime intervention

1=DIR/Floortime intervention

Group Type EXPERIMENTAL

DIR/Floortime

Intervention Type BEHAVIORAL

Developmental, Individual-Difference, Relationship-Bases (DIR) focus more on relationship, social skills, and meaningful, spontaneous use of language and communication and integrated understand of human development

routine care

2=routine care

Group Type ACTIVE_COMPARATOR

Routine care

Intervention Type BEHAVIORAL

Routine care

Interventions

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DIR/Floortime

Developmental, Individual-Difference, Relationship-Bases (DIR) focus more on relationship, social skills, and meaningful, spontaneous use of language and communication and integrated understand of human development

Intervention Type BEHAVIORAL

Routine care

Routine care

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

Other Identifiers

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194/2550 (EC2)

Identifier Type: -

Identifier Source: org_study_id

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