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Clinical Trials/NCT01794013
NCT01794013
Completed
N/A

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

Kingkaew Pajareya1 site in 1 country48 target enrollmentMarch 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Kingkaew Pajareya
Enrollment
48
Locations
1
Primary Endpoint
The change in The Child Behavior Rating Scale (CBRS)
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
December 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kingkaew Pajareya
Responsible Party
Sponsor Investigator
Principal Investigator

Kingkaew Pajareya

Faculty of Medicine Siriraj Hospital

Mahidol University

Eligibility Criteria

Inclusion Criteria

  • The children with developmental disabilities :
  • age between 2 - 6 years of age
  • living with the primary caregiver for at least 6 months.

Exclusion Criteria

  • The children are excluded if :
  • 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

Outcomes

Primary Outcomes

The change in The Child Behavior Rating Scale (CBRS)

Time Frame: 4 months

Secondary Outcomes

  • The change in The Functional Emotional Developmental Questionnaire (FEDQ)(4 months)

Study Sites (1)

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