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

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.

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Key information

Conditions

Autistic Spectrum Disorders Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DIR/Floortime

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

Behavioral

Routine care

Primary outcomes

The Functional Emotional Assessment Scale (FEAS) Ratings (the child part)

Time frame: at the beginning of the first session and at the 3 months follow up

Secondary outcomes

The Childhood Autism Rating Scale (CARS) Clinical rating of the children (6 point scale related to Greenspan's six Functional Development Level -FDL) Satisfaction of the effectiveness of the intervention of their child (Six-point Likert scale)

Time frame: at the beginning of the first session and the 3 months follow up

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

A Pilot Randomized Controlled Trial of a DIR/ Floortime Parent Training Intervention for Pre-school Children With Autistic Spectrum Disorders

Acronym: DIR

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2009
First posted: Aug 6, 2009
Registry last updated: Aug 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed