- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04413630
Workshops for Toddlers With Speech and Language Developmental Delay
2. juni 2020 opdateret af: Taipei Medical University
Therapeutic Effects of Family-centered 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
Studieoversigt
Detaljeret beskrivelse
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
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
122
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Taipei, Taiwan, 111-01
- Shin Kong Wu Ho-Su Memorial Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
1 år til 3 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Study group
family workshop
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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
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Chinese Communicative Developmental Inventory
Tidsramme: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
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assess communication and language function of children
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scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Peabody Developmental Motor Scales
Tidsramme: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
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assess fine motor function of children
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scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
|
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Pediatric Outcomes Data Collection Instrument
Tidsramme: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
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measure the functional performance of children
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scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
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Child Health Questionnaire-Parent Form 28
Tidsramme: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
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assess the health status of children
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scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
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Pediatric Quality of Life Inventory-Geriatric Core Scales
Tidsramme: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
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measure the quality of life of children
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scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
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Caregiver Strain Index
Tidsramme: scores change from baseline to 6 weeks after treatment, higher scores mean a worse outcome
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assess family strain
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scores change from baseline to 6 weeks after treatment, higher scores mean a worse outcome
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Impact on Family Scale
Tidsramme: scores change from baseline to 6 weeks after treatment, higher scores mean a worse outcome
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assess the effects of a child's illness of the function of the family system
|
scores change from baseline to 6 weeks after treatment, higher scores mean a worse outcome
|
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Pediatric Quality of Life Inventory-Family Impact Module
Tidsramme: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
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assess the impact of pediatric conditions on family function and quality of life
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scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
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World Health Organization Quality of Life Brief Version
Tidsramme: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
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evaluate parents' quality of life
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scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
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Parental satisfaction questionnaire
Tidsramme: after completion of 6 weeks of workshop
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assess the parents' subjective satisfaction to the whole workshop itself, score ranges from 0 to 100, higher scores mean a higher satisfaction
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after completion of 6 weeks of workshop
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Emotional Competency Rating Scales
Tidsramme: scores change from baseline to 6 weeks after treatment
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assess emotional function of children, higher scores mean a better outcome
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scores change from baseline to 6 weeks after treatment
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2014
Primær færdiggørelse (Faktiske)
31. december 2018
Studieafslutning (Faktiske)
31. december 2018
Datoer for studieregistrering
Først indsendt
29. maj 2020
Først indsendt, der opfyldte QC-kriterier
2. juni 2020
Først opslået (Faktiske)
4. juni 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. juni 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. juni 2020
Sidst verificeret
1. maj 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- SKH-109
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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