Early Intervention for Developmental Delay

Child Development Clinical Trial

Official title:

Effectiveness of Adjunctive Sensory Integration Therapy for Children With Developmental Delay in an Early Intervention Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03223688
• Other study ID #: 105-1742C1
• 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
• 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

Related Conditions & MeSH terms

• Child Development
• Developmental Delay
• Early Intervention

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