DIR/ Floortime™ Parent Training Intervention for the Children With Developmental Disabilities (RCT/DD)
Primary Purpose
Cerebral Palsy, Down's Syndrome, Delayed Development
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Parent training
Routine care
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring Parent training, DIR/ Floortime Approach, Children with developmental disabilities
Eligibility Criteria
Inclusion Criteria:
The children with developmental disabilities :
- age between 2 - 6 years of age
- ambulatory
- living with the primary caregiver for at least 6 months.
Exclusion Criteria:
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
Sites / Locations
- Kingkaew Pajareya
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Parent trianing
Routine care
Arm Description
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.
The children in the control group will continue their standard routine care.
Outcomes
Primary Outcome Measures
The change in The Child Behavior Rating Scale (CBRS)
Secondary Outcome Measures
The change in The Functional Emotional Developmental Questionnaire (FEDQ)
Full Information
NCT ID
NCT01794013
First Posted
February 14, 2013
Last Updated
March 5, 2019
Sponsor
Kingkaew Pajareya
Collaborators
Mahidol University
1. Study Identification
Unique Protocol Identification Number
NCT01794013
Brief Title
DIR/ Floortime™ Parent Training Intervention for the Children With Developmental Disabilities
Acronym
RCT/DD
Official Title
A Randomized Controlled Trial of DIR/ Floortime™ Parent Training Intervention for the Children With Developmental Disabilities
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kingkaew Pajareya
Collaborators
Mahidol University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Down's Syndrome, Delayed Development
Keywords
Parent training, DIR/ Floortime Approach, Children with developmental disabilities
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parent trianing
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Routine care
Arm Type
Active Comparator
Arm Description
The children in the control group will continue their standard routine care.
Intervention Type
Behavioral
Intervention Name(s)
Parent training
Other Intervention Name(s)
DIR/ Floortime parent training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Routine care
Intervention Description
routine care
Primary Outcome Measure Information:
Title
The change in The Child Behavior Rating Scale (CBRS)
Time Frame
4 months
Secondary Outcome Measure Information:
Title
The change in The Functional Emotional Developmental Questionnaire (FEDQ)
Time Frame
4 months
Other Pre-specified Outcome Measures:
Title
The change in The Mullen Scales of Early Learning (MSEL)
Time Frame
4 months
Title
The change in The Parenting Stress Index-Short Form (PSI-SF)
Time Frame
4 months
Title
Client's Satisfaction
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
72 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The children with developmental disabilities :
age between 2 - 6 years of age
ambulatory
living with the primary caregiver for at least 6 months.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kingkaew Pajareya, MD
Organizational Affiliation
Faculty of Medicine Siriraj Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kingkaew Pajareya
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
DIR/ Floortime™ Parent Training Intervention for the Children With Developmental Disabilities
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