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

NCT01794013 | Completed DMC

• 1 other identifier: Si089/2013
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Down's Syndrome; Delayed Development

Keywords

Parent training; DIR/ Floortime Approach; Children with developmental disabilities

Outcome Measures

Primary Outcomes (1)

• The change in The Child Behavior Rating Scale (CBRS)

  4 months

Secondary Outcomes (1)

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

  4 months

Other Outcomes (3)

• 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

Study Arms (2)

Parent trianing

ACTIVE COMPARATOR

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

Routine care

ACTIVE COMPARATOR

The children in the control group will continue their standard routine care.

Behavioral: Routine care

Interventions

Parent training BEHAVIORAL

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.

Also known as: DIR/ Floortime parent training

Parent trianing

Routine care BEHAVIORAL

routine care

Routine care

Eligibility Criteria

• Age: 24 Months - 72 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• The children are excluded if :
• autism
• deaf
• blind
• 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

Sponsors & Collaborators

• Kingkaew Pajareya: lead
• Mahidol University: collaborator

Study Sites (1)

Kingkaew Pajareya

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Cerebral Palsy; Down Syndrome; Learning Disabilities

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Communication Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Kingkaew Pajareya, MD

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Faculty of Medicine Siriraj Hospital

Study Record Dates

• First Submitted: February 14, 2013
• First Posted: February 18, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 7, 2019

Record last verified: 2019-03

Locations

TH (1)