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Completed

NCT Number: NCT04413630

Workshops for Toddlers With Speech and Language Developmental Delay

The purpose of this study is to identify the therapeutic effects of family workshops on speech and language developmentally delayed children and their family

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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

18 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111-01, Taiwan

About this study

The family workshop with 5 courses, 6 families in one course, a 2-hour session per week, for 6 weeks.

Effects:

  • Investigate the therapeutic effects of the workshop for the toddlers with developmental delay
  • Investigate the therapeutic effects of the workshop for the parents of toddlers with developmental delay

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18 to 36 months old children with speech and language developmental delay with or without delay in gross motor, fine motor, cognition, and emotional or social function

the availability of toddlers and their parents to attend one 2-hour session of the workshop per week for 6 weeks

Exclusion criteria

  • Less than 18 months old or older than 36 months old

Treatment and study plan

family workshop

Other

The family workshop with 5 courses, with 6 families in one course The intervention of one course; 2 hours per session, one time per week, for a total of 6 weeks

Primary outcomes

  1. Chinese Communicative Developmental Inventory

    Time frame: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome

    assess communication and language function of children

Secondary outcomes

  1. Peabody Developmental Motor Scales

    Time frame: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome

    assess fine motor function of children

  2. Pediatric Outcomes Data Collection Instrument

    Time frame: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome

    measure the functional performance of children

  3. Child Health Questionnaire-Parent Form 28

    Time frame: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome

    assess the health status of children

  4. Pediatric Quality of Life Inventory-Geriatric Core Scales

    Time frame: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome

    measure the quality of life of children

  5. Caregiver Strain Index

    Time frame: scores change from baseline to 6 weeks after treatment, higher scores mean a worse outcome

    assess family strain

  6. Impact on Family Scale

    Time frame: scores change from baseline to 6 weeks after treatment, higher scores mean a worse outcome

    assess the effects of a child's illness of the function of the family system

  7. Pediatric Quality of Life Inventory-Family Impact Module

    Time frame: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome

    assess the impact of pediatric conditions on family function and quality of life

  8. World Health Organization Quality of Life Brief Version

    Time frame: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome

    evaluate parents' quality of life

  9. Parental satisfaction questionnaire

    Time frame: after completion of 6 weeks of workshop

    assess the parents' subjective satisfaction to the whole workshop itself, score ranges from 0 to 100, higher scores mean a higher satisfaction

  10. Emotional Competency Rating Scales

    Time frame: scores change from baseline to 6 weeks after treatment

    assess emotional function of children, higher scores mean a better outcome

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study title

Therapeutic Effects of Family-centered Workshops for Toddlers With Speech and Language Developmental Delay

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 4, 2020
Registry last updated
Jun 4, 2020

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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