Autistic Spectrum DisordersDIRNCT00954083
A Pilot Trial of a Developmental, Individual-Difference, Relationship-Bases (DIR)/Floortime for Children With Autistic Spectrum Disorders
A study testing DIR/Floortime and Routine care in people with Autistic Spectrum Disorders, run by Mahidol University.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Autistic Spectrum Disorders
- What is being tested?
- DIR/Floortime and Routine care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Apr 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- clinical criteria for Autistic Disorders according to DSM IV
- child is 2 - 6 years of age
Who cannot join
- 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
About this study
Official title: A Pilot Randomized Controlled Trial of a DIR/ Floortime Parent Training Intervention for Pre-school 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.
- Conditions
- Autistic Spectrum Disorders
- Being tested
- DIR/Floortime, Routine care
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIR/FloortimeBehavioural
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 careBehavioural
Routine care
| Study group | Role | What they receive |
|---|---|---|
| DIR/Floortime intervention | Experimental | 1=DIR/Floortime intervention Receives: Behavioral: DIR/Floortime |
| routine care | Active comparator | 2=routine care Receives: Behavioral: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Functional Emotional Assessment Scale (FEAS) Ratings (the child part)
Measured: at the beginning of the first session and at the 3 months follow up
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)
Measured: at the beginning of the first session and the 3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startJun 2007
- Primary completionOct 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Investigators
- Kingkaew Pajareya, MD, Principal investigator, Rehabilitation Medicine, Siriraj Hospital, Bangkok, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954083
- Sponsor's protocol ID
- 194/2550 (EC2)
- Acronym
- DIR
- Status last verified
- Aug 2009
- First submitted
- 4 Aug 2009
- Last updated
- 6 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial of a DIR/ Floortime Parent Training Intervention for Pre-school Children With Autistic Spectrum Disorders
- ClinicalTrials.gov ID
- NCT00954083
- Acronym / sponsor ID
- DIR / 194/2550 (EC2)
- Conditions
- Autistic Spectrum Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DIR/Floortime intervention | Experimental | Behavioral: DIR/Floortime1=DIR/Floortime intervention |
| routine care | Active comparator | Behavioral: Routine care2=routine care |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- clinical criteria for Autistic Disorders according to DSM IV
- child is 2 - 6 years of age
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DIR/FloortimeDevelopmental, 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 | Behavioural | DIR/Floortime intervention |
| Routine careRoutine care | Behavioural | routine care |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kingkaew Pajareya, MD principal investigator
Rehabilitation Medicine, Siriraj Hospital, Bangkok, Thailand
Questions about this trial
What is this clinical trial studying?
A study testing DIR/Floortime and Routine care in people with Autistic Spectrum Disorders, run by Mahidol University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2009.