Early Intervention for Developmental Delay

NCT03223688 | Completed DMC

• 1 other identifier: 105-1742C1
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Child Development; Developmental Delay; Early Intervention

Outcome Measures

Primary Outcomes (1)

• Changes of children's development

  Mullen Scales of Early Learning

  Assessment will be performed at baseline and 6-month after the baseline

Secondary Outcomes (2)

• Changes of caregivers' life quality

  Assessment will be performed at baseline and 6-month after the baseline

• Changes of caregivers' parenting stress

  Assessment will be performed at baseline and 6-month after the baseline

Study Arms (3)

Day-Care early intervention program

EXPERIMENTAL

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.

Behavioral: Day-Care early intervention program

OPD+SI intervention program

EXPERIMENTAL

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.

Behavioral: OPD+SI intervention program

OPD intervention program

ACTIVE COMPARATOR

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.

Behavioral: OPD intervention program

Interventions

Day-Care early intervention program BEHAVIORAL

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.

Day-Care early intervention program

OPD+SI intervention program BEHAVIORAL

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.

Also known as: Adjunctive Sensory Integration (SI) Therapy

OPD+SI intervention program

OPD intervention program BEHAVIORAL

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.

OPD intervention program

Eligibility Criteria

• Age: 2 Years - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Autism
• Cerebral palsy

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Conditions

Learning Disabilities

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Liang-Jen Wang

  Chang Gung Memorial Hospital, Kaohsiung, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Visiting Staff

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 21, 2017
• Study Start: May 12, 2014
• Primary Completion: May 11, 2017
• Study Completion: May 11, 2017
• Last Updated: July 21, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share