Cerebral PalsyRCT/DDNCT01794013
DIR/ Floortime™ Parent Training Intervention for the Children With Developmental Disabilities
A study testing Parent training and Routine care in people with Cerebral Palsy and Down's Syndrome, run by Kingkaew Pajareya at 1 site in Thailand.
Trial summary
The objective of this study is to test whether adding the parent training program using the relationship-based approach could help the children with development disabilities (DDs) would confer additional benefits over routine clinical care available to both groups in terms of improving their development and reducing… Read more about this study
- Who is it for?
- Ages 24 to 72 months
- Conditions the study is for
- Cerebral Palsy, Down's Syndrome, Delayed Development
- What is being tested?
- Parent training and Routine care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2013to Dec 2016
- 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 24 to 72 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The children with developmental disabilities :
- age between 2 - 6 years of age
- ambulatory
- living with the primary caregiver for at least 6 months.
Who cannot join
- The children are excluded if :
- autism
- deaf
- blind
- serious medical problems (e.g. severe congenital heart disease, intractable seizure (a seizure frequency of at least one attack per month during six months despite receiving two anticonvulsant drugs)
- their parents : not literate, has known chronic psychiatric, or physical illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of DIR/ Floortime™ Parent Training Intervention for the Children With Developmental Disabilities
The objective of this study is to test whether adding the parent training program using the relationship-based approach could help the children with development disabilities (DDs) would confer additional benefits over routine clinical care available to both groups in terms of improving their development and reducing behavior problems.
Read the detailed description
The objective of this study is to test whether adding the parent training program using the relationship-based approach could help the children with development disabilities (DDs) would confer additional benefits over routine clinical care available to both groups in terms of improving their development and reducing behavior problems.
The study treatment involves intervention entirely with parents of children with DDs, rather than directly with the children themselves. Before the first session, all parents in the intervention group had to learn about DIR/ Floortime™ model approach through 1 - hour one on one coaching (at the beginning oft the study, the end of 1st and 3rd month) and through 2 hours DVD lecture and a pocket book. The parent in the intervention group will be asked to carry out FloortimeTM together with using Floortime strategies during daily activities a minimum of 15 hour per week. Meanwhile, the children in the control groups will continue their routine care. The baseline assessment and follow up time schedule were similar to those of the intervention group.
- Conditions
- Cerebral Palsy, Down's Syndrome, Delayed Development
- Being tested
- Parent training, Routine care
- Keywords
- Parent training, DIR/ Floortime Approach, Children with developmental disabilities
- Medical subject headings
- Cerebral Palsy, Down Syndrome, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent trainingBehavioural
Also called DIR/ Floortime parent training
All parents in the intervention group had to learn about DIR/ Floortime™ model approach through one on one coaching (1 hour/ session for three sessions) and through 2 hours DVD lecture.
Routine careBehavioural
routine care
| Study group | Role | What they receive |
|---|---|---|
| Parent trianing | Active comparator | The parent training group will learn about DIR/ Floortime™ model approach through one on one coaching for 1 hour at the beginning of the study, the end of 1st and 3th month and through 2 hours DVD lecture and a pocket book. Receives: Behavioral: Parent training |
| Routine care | Active comparator | The children in the control group will continue their standard routine care. Receives: Behavioral: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in The Child Behavior Rating Scale (CBRS)
Measured: 4 months
Secondary outcomes (1)
The change in The Functional Emotional Developmental Questionnaire (FEDQ)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kingkaew Pajareya
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol University
- Responsible party
- Sponsor-investigator, Kingkaew Pajareya, Mahidol University
- Investigators
- Kingkaew Pajareya, MD, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794013
- Sponsor's protocol ID
- Si089/2013
- Acronym
- RCT/DD
- Status last verified
- Mar 2019
- First submitted
- 14 Feb 2013
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of DIR/ Floortime™ Parent Training Intervention for the Children With Developmental Disabilities
- ClinicalTrials.gov ID
- NCT01794013
- Acronym / sponsor ID
- RCT/DD / Si089/2013
- Conditions
- Cerebral Palsy, Down's Syndrome, Delayed Development
- Keywords
- Parent training, DIR/ Floortime Approach, Children with developmental disabilities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Kingkaew PajareyaUniversity, hospital or other
- Collaborators
- Mahidol University
- Study start
- Mar 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Feb 2013 (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.
The objective of this study is to test whether adding the parent training program using the relationship-based approach could help the children with development disabilities (DDs) would confer additional benefits over routine clinical care available to both groups in terms of improving their development and reducing behavior problems.
Detailed description
The objective of this study is to test whether adding the parent training program using the relationship-based approach could help the children with development disabilities (DDs) would confer additional benefits over routine clinical care available to both groups in terms of improving their development and reducing behavior problems.
The study treatment involves intervention entirely with parents of children with DDs, rather than directly with the children themselves. Before the first session, all parents in the intervention group had to learn about DIR/ Floortime™ model approach through 1 - hour one on one coaching (at the beginning oft the study, the end of 1st and 3rd month) and through 2 hours DVD lecture and a pocket book. The parent in the intervention group will be asked to carry out FloortimeTM together with using Floortime strategies during daily activities a minimum of 15 hour per week. Meanwhile, the children in the control groups will continue their routine care. The baseline assessment and follow up time schedule were similar to those of the intervention group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent trianing | Active comparator | Behavioral: Parent trainingThe parent training group will learn about DIR/ Floortime™ model approach through one on one coaching for 1 hour at the beginning of the study, the end of 1st and 3th month and through 2 hours DVD lecture and a pocket book. |
| Routine care | Active comparator | Behavioral: Routine careThe children in the control group will continue their standard routine care. |
Who may qualify
- Ages
- 24 to 72 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- age between 2 - 6 years of age
- ambulatory
- living with the primary caregiver for at least 6 months.
Key exclusion criteria (6 listed)
- autism
- deaf
- blind
- serious medical problems (e.g. severe congenital heart disease, intractable seizure (a seizure frequency of at least one attack per month during six months despite receiving two anticonvulsant drugs)
- their parents : not literate, has known chronic psychiatric, or physical illness
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 |
|---|---|---|
| Parent trainingAlso: DIR/ Floortime parent trainingAll parents in the intervention group had to learn about DIR/ Floortime™ model approach through one on one coaching (1 hour/ session for three sessions) and through 2 hours DVD lecture. | Behavioural | Parent trianing |
| Routine careroutine care | Behavioural | Routine care |
Primary outcome
The change in The Child Behavior Rating Scale (CBRS)
Time frame: 4 months
1 secondary outcome
The change in The Functional Emotional Developmental Questionnaire (FEDQ)
Time frame: 4 months
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 7 Mar 2019.
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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
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent training and Routine care in people with Cerebral Palsy and Down's Syndrome, run by Kingkaew Pajareya 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 4 inclusion and 6 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 7 Mar 2019. 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 change in The Child Behavior Rating Scale (CBRS) (time frame: 4 months). 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 7 Mar 2019.