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

Cerebral Palsy Clinical Trial

— RCT/DD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01794013
• Other study ID #: Si089/2013
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: December 2016

Study information

• Verified date: March 2019
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Months to 72 Months

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Delayed Development
• Developmental Disabilities
• Down Syndrome
• Down's Syndrome

Intervention

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.
• Routine care
routine care

Locations

Country	Name	City	State
Thailand	Kingkaew Pajareya	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Kingkaew Pajareya	Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The change in The Mullen Scales of Early Learning (MSEL)		4 months
Other	The change in The Parenting Stress Index-Short Form (PSI-SF)		4 months
Other	Client's Satisfaction		4 months
Primary	The change in The Child Behavior Rating Scale (CBRS)		4 months
Secondary	The change in The Functional Emotional Developmental Questionnaire (FEDQ)		4 months