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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01794013
Acronym
RCT/DD
Enrollment
48
Registered
2013-02-18
Start date
2013-03-31
Completion date
2016-12-31
Last updated
2019-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, Delayed Development, Down's Syndrome

Keywords

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

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.

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.

Interventions

BEHAVIORALParent 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.

BEHAVIORALRoutine care

routine care

Sponsors

Mahidol University
CollaboratorOTHER
Kingkaew Pajareya
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
24 Months to 72 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The change in The Child Behavior Rating Scale (CBRS)4 months

Secondary

MeasureTime frame
The change in The Functional Emotional Developmental Questionnaire (FEDQ)4 months

Other

MeasureTime 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 Satisfaction4 months

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026