Child Development, Developmental Delay, Early Intervention
Conditions
Brief summary
This study aims to investigate the effectiveness of early intervention program in Department of Children and Adolescent Psychiatry, Kaohsiung Chang Gung Memorial Hospital. The investigators assume that the frequency of early-intervention and degree of family involvement will be associate with the treatment outcome.
Detailed description
This prospective, non-randomized, open-label study is performed to assess the effects of adjunctive SI in the family-based treatment program of children with developmental delay (DD). The study subjects are children with DD who attended an early intervention (EI) program at Kaohsiung Chang Gung Memorial Hospital, which is the largest general hospital in the Southern Taiwan. Each participating child undergo a joint assessment by a pediatrician, a rehabilitation doctor, a child psychiatrist, a speech therapist, a physical therapist, an occupational therapist, and a social worker. Once the diagnosis of developmental delay is confirmed, the child will be scheduled for prescribed family-based early intervention in the same hospital. Children (between 2 to 4 years old) who attend the program will be enrolled in this study. Informed consent will be obtained from the children and their primary caregivers after they received a complete description of the study. The participants are categorized into three different groups based on their intervention method. The choice of intervention method will be according to the willingness and expedience of the children's caregivers.
Interventions
BEHAVIORALDay-Care early intervention program
The daily treatment session had eight children along with their major caregivers. The treatment was conducted by two experienced occupational therapists (OT), and each session lasted for four hours in the week-day morning with a 10-minute break. The goal of the sessions was to enhance children's development through cognitive training, behavioral modification plan and parenting skill training.
BEHAVIORALOPD+SI intervention program
The treatment program had eight children along with their major caregivers. The treatment was also performed by two experienced OT, and each session lasted for one hours, once a week. The sessions consisted of cognitive training, behavioral modification plan and parenting skill training. Adjunctive SI therapy was also performed by said OT for improving children's sensory motor development in an additional hour.
BEHAVIORALOPD intervention program
The treatment program had eight children along with their major caregivers. The treatment was also performed by two experienced OT, and each session lasted for one hours, once a week. The sessions consisted of cognitive training, behavioral modification plan and parenting skill training.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 4 Years
Healthy volunteers
Yes
Inclusion criteria
* Children with Developmental Delay * The caregivers are able to participate in the treatment program
Exclusion criteria
* Autism * Cerebral palsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of children's development | Assessment will be performed at baseline and 6-month after the baseline | Mullen Scales of Early Learning |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of caregivers' life quality | Assessment will be performed at baseline and 6-month after the baseline | The World Health Organization Quality of Life- BREF (WHOQOL-BREF) |
| Changes of caregivers' parenting stress | Assessment will be performed at baseline and 6-month after the baseline | The Parenting Stress Index-Short Form (PSI-SF) |
Outcome results
None listed