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

Not Applicable

Completed

• Conditions: Cerebral Palsy; Delayed Development; Down's Syndrome
• Interventions: Behavioral: Routine care; Behavioral: Parent training

• Registration Number: NCT01794013
• Lead Sponsor: Kingkaew Pajareya

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.

Study Timeline

• Study First Submitted: 2013-02-14
• Study First Submitted QC: 2013-02-15
• Study First Posted: 2013-02-18
• Study Start: 2013-03
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-05
• Last Update Posted: 2019-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

The children with developmental disabilities :

1. age between 2 - 6 years of age
2. ambulatory
3. living with the primary caregiver for at least 6 months.

Exclusion Criteria

The children are excluded if :

1. autism
2. deaf
3. blind
4. 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)
5. their parents : not literate, has known chronic psychiatric, or physical illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine care	Routine care	The children in the control group will continue their standard routine care.
Parent trianing	Parent training	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.

Primary Outcome Measures

Name	Time	Method
The change in The Child Behavior Rating Scale (CBRS)	4 months

Secondary Outcome Measures

Name	Time	Method
The change in The Functional Emotional Developmental Questionnaire (FEDQ)	4 months

Trial Locations

Locations (1)

Kingkaew Pajareya; 🇹🇭 Bangkok, Thailand