DIR/ Floortime™ Parent Training Intervention for the Children With Developmental Disabilities (RCT/DD)

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Down's Syndrome; Delayed Development
• Intervention / Treatment: Behavioral: Parent training; Behavioral: Routine care

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Kingkaew Pajareya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: DIR/ Floortime parent training
ACTIVE_COMPARATOR: Routine care; The children in the control group will continue their standard routine care.	Behavioral: Routine care; routine care

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
The change in The Mullen Scales of Early Learning (MSEL)	4 months
The change in The Parenting Stress Index-Short Form (PSI-SF)	4 months
Client's Satisfaction	4 months

Collaborators and Investigators

• Sponsor: Kingkaew Pajareya
• Collaborators: Mahidol University
• Investigators: Principal Investigator: Kingkaew Pajareya, MD, Faculty of Medicine Siriraj Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ACTUAL): December 1, 2016
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: February 14, 2013
• First Submitted That Met QC Criteria: February 15, 2013
• First Posted (ESTIMATE): February 18, 2013

Study Record Updates

• Last Update Posted (ACTUAL): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 5, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Parent training; DIR/ Floortime Approach; Children with developmental disabilities
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Congenital Abnormalities; Brain Damage, Chronic; Genetic Diseases, Inborn; Intellectual Disability; Neurodevelopmental Disorders; Abnormalities, Multiple; Chromosome Disorders; Cerebral Palsy; Down Syndrome; Developmental Disabilities
• Other Study ID Numbers: Si089/2013