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Completed

NCT Number: NCT01794013

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The children with developmental disabilities :

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

Exclusion criteria

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

Treatment and study plan

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.

Other names: DIR/ Floortime parent training

Routine Care

Behavioral

routine care

Primary outcomes

  1. The change in The Child Behavior Rating Scale (CBRS)

    Time frame: 4 months

Secondary outcomes

  1. The change in The Functional Emotional Developmental Questionnaire (FEDQ)

    Time frame: 4 months

Other outcomes

  1. The change in The Mullen Scales of Early Learning (MSEL)

    Time frame: 4 months

  2. The change in The Parenting Stress Index-Short Form (PSI-SF)

    Time frame: 4 months

  3. Client's Satisfaction

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Kingkaew Pajareya

Other

Collaborators

  • Mahidol University

Registry information

Official study title

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

Acronym: RCT/DD

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 18, 2013
Registry last updated
Mar 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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