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

This study is not yet open for participant recruitment.
Verified February 2013 by Mahidol University
Sponsor:
Collaborator:
Mahidol University
Information provided by (Responsible Party):
Kingkaew Pajareya, Mahidol University
ClinicalTrials.gov Identifier:
NCT01794013
First received: February 14, 2013
Last updated: February 15, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Cerebral Palsy
Down's Syndrome
Delayed Development
Behavioral: Parent training
Behavioral: Routine care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of DIR/ Floortime™ Parent Training Intervention for the Children With Developmental Disabilities

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • The change in The Child Behavior Rating Scale (CBRS) [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change in The Functional Emotional Developmental Questionnaire (FEDQ) [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • The change in The Mullen Scales of Early Learning (MSEL) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • The change in The Parenting Stress Index-Short Form (PSI-SF) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Client's Satisfaction [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: March 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.

  Eligibility

Ages Eligible for Study:   24 Months to 72 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01794013

Contacts
Contact: Kingkaew Pajareya, MD 662 419 7508

Locations
Thailand
Kingkaew Pajareya Not yet recruiting
Bangkok, Thailand, 10700
Contact: Surrelak Sutchritpongsa, MD    662 419 5742    sureelak.sut@mahidol.ac.th   
Sub-Investigator: Ratcharin Kongkasuwan, MD         
Sponsors and Collaborators
Kingkaew Pajareya
Mahidol University
Investigators
Principal Investigator: Kingkaew Pajareya, MD Faculty of Medicine Siriraj Hospital
  More Information

No publications provided

Responsible Party: Kingkaew Pajareya, Faculty of Medicine Siriraj Hospital, Mahidol University
ClinicalTrials.gov Identifier: NCT01794013     History of Changes
Other Study ID Numbers: Si089/2013
Study First Received: February 14, 2013
Last Updated: February 15, 2013
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
Parent training
DIR/ Floortime Approach
Children with developmental disabilities

Additional relevant MeSH terms:
Developmental Disabilities
Cerebral Palsy
Down Syndrome
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Mental Disorders Diagnosed in Childhood
Mental Disorders
Mental Retardation
Neurobehavioral Manifestations
Neurologic Manifestations
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on April 15, 2014