Clinical trial NCT01794013: DIR/ Floortime™ Parent Training Intervention for the Children With Developmental Disabilities
Official title: A Randomized Controlled Trial of DIR/ Floortime™ Parent Training Intervention for the Children With Developmental Disabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Down's Syndrome
Delayed Development
Keywords: Parent training
DIR/ Floortime Approach
Children with developmental disabilities
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Mahidol University
First posted: 2013-02-18
Enrollment: 48
Sex: ALL
Minimum age (years): 24
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: The change in The Child Behavior Rating Scale (CBRS)
timeFrame: 4 months
Secondary outcomes:
measure: The change in The Functional Emotional Developmental Questionnaire (FEDQ)
timeFrame: 4 months
Other outcomes:
measure: The change in The Mullen Scales of Early Learning (MSEL)
timeFrame: 4 months
measure: The change in The Parenting Stress Index-Short Form (PSI-SF)
timeFrame: 4 months
measure: Client's Satisfaction
timeFrame: 4 months
Locations:
city: Bangkok
country: Thailand
facility: Kingkaew Pajareya
Study officials:
affiliation: Siriraj Hospital
name: Kingkaew Pajareya, MD
role: PRINCIPAL_INVESTIGATOR
References: