DIR/ Floortime™ Parent Training Intervention for the Children With Developmental Disabilities

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Trial of DIR/ Floortime™ Parent Training Intervention for the Children With Developmental Disabilities

Conditions
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Cerebral Palsy, Down's Syndrome, Delayed Development

Intervention / Treatment
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* Behavioral: Parent training
* Behavioral: Routine care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 24 Months
Maximum Age: 72 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Parent trianing<br>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. | Behavioral: Parent training<br>* 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.<br>* Other names: DIR/ Floortime parent training;|
| Active Comparator: Routine care<br>The children in the control group will continue their standard routine care. | Behavioral: Routine care<br>* routine care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in The Child Behavior Rating Scale (CBRS) |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in The Functional Emotional Developmental Questionnaire (FEDQ) |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parent training, DIR/ Floortime Approach, Children with developmental disabilities