Autism Spectrum DisordersDIRNCT00954213
A Study of a Developmental,Individual-Difference,Relationship-Bases/Floortime Intervention for Children With Autistic
A study testing DIR/Floortime parent intervention in people with Autism Spectrum Disorders, run by Mahidol University at 1 site in Thailand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorders
- What is being tested?
- DIR/Floortime parent intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- May 2008to Jun 2010
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A One-year Prospective Follow-up Study of a DIR/ Floortime Parent Training Intervention for Pre-school Children With Autistic Spectrum Disorders
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.
- Conditions
- Autism Spectrum Disorders
- Being tested
- DIR/Floortime parent intervention
- 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/Floortime parent interventionBehavioural
Parent will be trained to observe their autistic child's cues, follow their child's lead and techniques to enhance his/her development.
| Study group | Role | What they receive |
|---|---|---|
| DIR/Floortime parent intervention | Experimental | Not described Receives: Behavioral: DIR/Floortime parent intervention |
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: 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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startMay 2008
- Primary completionMar 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT00954213
- Sponsor's protocol ID
- 206/2551(EC1)
- Acronym
- DIR
- Status last verified
- Jul 2010
- First submitted
- 4 Aug 2009
- Last updated
- 26 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A One-year Prospective Follow-up Study of a DIR/ Floortime Parent Training Intervention for Pre-school Children With Autistic Spectrum Disorders
- ClinicalTrials.gov ID
- NCT00954213
- Acronym / sponsor ID
- DIR / 206/2551(EC1)
- Conditions
- Autism Spectrum Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 7 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DIR/Floortime parent intervention | Experimental | Behavioral: DIR/Floortime parent intervention |
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/Floortime parent interventionParent will be trained to observe their autistic child's cues, follow their child's lead and techniques to enhance his/her development. | Behavioural | DIR/Floortime parent intervention |
Primary outcome
The Functional Emotional Assessment Scale (FEAS) Ratings (the child part)
Time frame: 1 year
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: 1 year
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 26 Jul 2010.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIR/Floortime parent intervention in people with Autism Spectrum Disorders, run by Mahidol University at 1 site in Thailand.
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 26 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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: 1 year). 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 26 Jul 2010.