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Completed

NCT Number: NCT02115334

Development and Effectiveness of Home-based Programs for Preschool Children With Developmental Delay

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.

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Key information

Conditions

Developmental Delay Communication Disorders Learning Disabilities Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

About this study

A total of 36 children with DD, aged 2-6 years, were randomly assigned to the professional-based group (professional therapists delivering the PHPA, total n=13), parents-based group (parents executing the PHPA, n=12) and control group (health education only, n=11). Outcome measures included clinical assessments and subjective questionnaires. The clinical assessments were Comprehensive Developmental Inventory for Infants and Toddlers (CDIIT). The subjective questionnaires were Chinese Child Developmental Inventory (CCDI), Assessment of preschool children's participation (APCP), TN0-AZL Preschool quality of life (TAPQOL) and parent stress index (PSI). Tests were administrated before and after the intervention.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • unstable physiological conditions
  • progression or regression symptoms

Treatment and study plan

professional therapists delivering the PHPA

Behavioral

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

Other names: PHPA(delivered by professional therapists)

parents executing the PHPA

Behavioral

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

Other names: PHPA (executed by parents)

Health Education

Behavioral

health education of the children with DD.

Primary outcomes

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

    Time frame: baseline, 8 weeks, 3 months, 6 months

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

Secondary outcomes

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

    Time frame: baseline, 8 weeks, 3 months, 6 months

    Measurement of CCDI.

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

    Time frame: baseline, 8 weeks, 3 months, 6 months

    Measurement of APCP.

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

    Time frame: baseline, 8 weeks, 3 months, 6 months

    Measurement of TAPQOL.

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

    Time frame: baseline, 8 weeks, 3 months, 6 months

    Measurement of PSI.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Development and Effectiveness of Home-based Programs for Preschool Children With Developmental Delay:a Randomized Controlled Trial.

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 16, 2014
Registry last updated
Feb 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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