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Completed

NCT Number: NCT00954213

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

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.

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Key information

Conditions

Autism 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

Primary location

Kingkaew Pajareya

Bangkoknoi, Bangkok, 10700, Thailand

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 parent intervention

Behavioral

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

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

  1. 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: 1 year

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

A One-year Prospective Follow-up Study of a DIR/ Floortime Parent Training Intervention for Pre-school Children With Autistic Spectrum Disorders

Acronym: DIR

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 7, 2009
Registry last updated
Jul 26, 2010

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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