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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00954083

Acronym

DIR

Enrollment

Registered

2009-08-06

Start date

2007-06-30

Completion date

2009-04-30

Last updated

2009-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autistic Spectrum Disorders

Brief summary

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.

Interventions

BEHAVIORALDIR/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

BEHAVIORALRoutine care

Routine care

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

2 Years to 6 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
The Functional Emotional Assessment Scale (FEAS) Ratings (the child part)	at the beginning of the first session and at the 3 months follow up

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026