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

Mahidol University

Status: Completed

Conditions: Autistic Spectrum Disorders

Treatments: Behavioral: Routine care; Behavioral: DIR/Floortime

Study type: Interventional

Funder types: Other

Identifiers

NCT00954083

194/2550 (EC2)

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 2 to 6 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

DIR/Floortime intervention

Experimental group

Description:

1=DIR/Floortime intervention

Treatment:

Behavioral: DIR/Floortime

routine care

Active Comparator group

Description:

2=routine care

Treatment:

Behavioral: Routine care