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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03223688
Other study ID # 105-1742C1
Secondary ID
Status Completed
Phase N/A
First received July 6, 2017
Last updated July 18, 2017
Start date May 12, 2014
Est. completion date May 11, 2017

Study information

Verified date July 2017
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date May 11, 2017
Est. primary completion date May 11, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 4 Years
Eligibility Inclusion Criteria:

- Children with Developmental Delay

- The caregivers are able to participate in the treatment program

Exclusion Criteria:

- Autism

- Cerebral palsy

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Day-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.
OPD+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.
OPD 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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Changes of children's development Mullen Scales of Early Learning Assessment will be performed at baseline and 6-month after the baseline
Secondary Changes of caregivers' life quality The World Health Organization Quality of Life- BREF (WHOQOL-BREF) Assessment will be performed at baseline and 6-month after the baseline
Secondary Changes of caregivers' parenting stress The Parenting Stress Index-Short Form (PSI-SF) Assessment will be performed at baseline and 6-month after the baseline
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