Early Intervention for Developmental Delay

Not Applicable

Completed

• Conditions: Child Development; Early Intervention; Developmental Delay
• Interventions: Behavioral: OPD intervention program; Behavioral: Day-Care early intervention program; Behavioral: OPD+SI intervention program

• Registration Number: NCT03223688
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study Start: 2014-05-12
• Primary Completion: 2017-05-11
• Study Completion: 2017-05-11
• Status Verified: 2017-07
• Study First Submitted: 2017-07-06
• Study First Submitted QC: 2017-07-18
• Last Update Submitted: 2017-07-18
• Study First Posted: 2017-07-21
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Children with Developmental Delay
• The caregivers are able to participate in the treatment program

Exclusion Criteria

• Autism
• Cerebral palsy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OPD intervention program	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.
Day-Care early intervention program	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. Said therapists assisted the caregivers in improving their nurturing and parenting skills with their children, as well as their techniques with regards to influencing them.
OPD+SI intervention program	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.

Primary Outcome Measures

Name	Time	Method
Changes of children's development	Assessment will be performed at baseline and 6-month after the baseline	Mullen Scales of Early Learning

Secondary Outcome Measures

Name	Time	Method
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)