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

Kingkaew Pajareya

Status: Completed

Conditions: Cerebral Palsy; Delayed Development; Down's Syndrome

Treatments: Behavioral: Parent training; Behavioral: Routine care

Study type: Interventional

Funder types: Other

Identifiers

NCT01794013

Si089/2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 24 to 72 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

Parent trianing

Active Comparator group

Description:

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.

Treatment:

Behavioral: Parent training

Routine care

Active Comparator group

Description:

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

Treatment:

Behavioral: Routine care