DIR/ Floortime™ Parent Training Intervention for the Children With Developmental Disabilities (RCT/DD)
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|ClinicalTrials.gov Identifier: NCT01794013|
Recruitment Status : Recruiting
First Posted : February 18, 2013
Last Update Posted : February 27, 2017
|Condition or disease||Intervention/treatment|
|Cerebral Palsy Down's Syndrome Delayed Development||Behavioral: Parent training Behavioral: Routine care|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomized Controlled Trial of DIR/ Floortime™ Parent Training Intervention for the Children With Developmental Disabilities|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||October 2017|
Active Comparator: Parent trianing
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
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.
Other Name: DIR/ Floortime parent training
Active Comparator: Routine care
The children in the control group will continue their standard routine care.
Behavioral: Routine care
- The change in The Child Behavior Rating Scale (CBRS) [ Time Frame: 4 months ]
- The change in The Functional Emotional Developmental Questionnaire (FEDQ) [ Time Frame: 4 months ]
- The change in The Mullen Scales of Early Learning (MSEL) [ Time Frame: 4 months ]
- The change in The Parenting Stress Index-Short Form (PSI-SF) [ Time Frame: 4 months ]
- Client's Satisfaction [ Time Frame: 4 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01794013
|Contact: Kingkaew Pajareya, MD||662 419 7508|
|Bangkok, Thailand, 10700|
|Contact: Surrelak Sutchritpongsa, MD 662 419 5742 email@example.com|
|Sub-Investigator: Ratcharin Kongkasuwan, MD|
|Principal Investigator:||Kingkaew Pajareya, MD||Faculty of Medicine Siriraj Hospital|