NCT02115334

Brief Summary

Early intervention refers to the provision of early detection, early diagnosis, and early intervention for infants and young children with special needs. The implementation of home programs is very important for children with developmental delay (DD). Therefore, the purposes of this study are to: (1) design the preschool home program activities(PHPA), (2) investigate the immediate efficacy of PHPA for children with DD, (3) investigate the long-term efficacy of PHPA for children with DD.The second year is to investigate the immediate efficacy of PHPA for children with DD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2013

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 16, 2014

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

February 27, 2015

Status Verified

June 1, 2011

Enrollment Period

3 years

First QC Date

September 27, 2013

Last Update Submit

February 25, 2015

Conditions

Developmental Delay

Keywords

Developmental delayEarly InterventionHome programsPreschool activities

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in clinical assessment after 8 weeks intervention of PHPA at 6 months

    The clinical assessments were Comprehensive Developmental Inventory for Infants and Toddlers (CDIIT).

    baseline, 8 weeks, 3 months, 6 months

Secondary Outcomes (4)

  • change from baseline in Chinese Child Developmental Inventory (CCDI) after 8 weeks intervention of PHPA at 6 months

    baseline, 8 weeks, 3 months, 6 months

  • change from baseline in Assessment of preschool children's participation(APCP) after 8 weeks intervention of PHPA at 6 months

    baseline, 8 weeks, 3 months, 6 months

  • change from baseline in TN0-AZL Preschool quality of life (TAPQOL) after 8 weeks intervention of PHPA at 6 months

    baseline, 8 weeks, 3 months, 6 months

  • change from baseline in parent stress index (PSI) after 8 weeks intervention of PHPA at 6 months

    baseline, 8 weeks, 3 months, 6 months

Study Arms (3)

professional-based group

EXPERIMENTAL

professional therapists delivering the PHPA

Behavioral: professional therapists delivering the PHPA

parents-based group

EXPERIMENTAL

parents executing the PHPA

Behavioral: parents executing the PHPA

control group

ACTIVE COMPARATOR

health education only

Behavioral: health education

Interventions

professional therapists delivering the PHPABEHAVIORAL

PHPA are delivered by professional therapists, which including gross motor, fine motor, cognition verbal, social interactions, activity of daily living(ADL).

Also known as: PHPA(delivered by professional therapists)
professional-based group
parents executing the PHPABEHAVIORAL

PHPA are executed by parents, which including gross motor, fine motor, cognition verbal, social interactions, ADL.

Also known as: PHPA (executed by parents)
parents-based group
health educationBEHAVIORAL

health education of the children with DD.

control group

Eligibility Criteria

AgeUp to 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • to 6-years-old children
  • clinical diagnosis of DD and other related disorders

You may not qualify if:

  • unstable physiological conditions
  • progression or regression symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taoyuan, 333, Taiwan

Location

MeSH Terms

Conditions

Learning Disabilities

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Chia-Ling Chen, MD,PhD

    Chang Gung Memorial Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2013

First Posted

April 16, 2014

Study Start

May 1, 2011

Primary Completion

May 1, 2014

Study Completion

July 1, 2014

Last Updated

February 27, 2015

Record last verified: 2011-06

Locations

TW(1)