Translating Evidence Based Developmental Screening Into Pediatric Primary Care (TEDS)
8. listopadu 2011 aktualizováno: Children's Hospital of Philadelphia
Translating Evidence Based Developmental Screening Into Pediatric Primary Care ( Aims 2 and 3 )
The purpose of this study is to examine the feasibility, acceptability and effectiveness of implementing the American Academy of Pediatrics (AAP's) recommendation that clinicians provide developmental surveillance at all well child visits and institute developmental screening at critical developmental periods in childhood, namely at 9, 18, 24 and 30 months of age.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
The purpose of this study is to examine the feasibility, acceptability and effectiveness of implementing the AAP's recommendation that clinicians provide developmental surveillance at all well child visits and institute developmental screening at critical developmental periods in childhood, namely at 9, 18, 24 and 30 months of age.
The study will also examine its acceptance by pediatric practices, its adoption and adaptation in urban pediatric practices, and the effectiveness of a developmental screening protocol that conforms to the AAP and Maternal and Child Health Bureau (MCHB) recommendations compared with that of developmental surveillance alone.
Typ studie
Intervenční
Zápis (Aktuální)
2314
Fáze
- Fáze 2
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Pennsylvania
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Philadelphia, Pennsylvania, Spojené státy, 19104
- CHOP - Primary Care Market Street
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Philadelphia, Pennsylvania, Spojené státy, 19104
- CHOP Primary Care-University City
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Philadelphia, Pennsylvania, Spojené státy, 19139
- CHOP Primary Care Center- Cobbs Creek
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Philadelphia, Pennsylvania, Spojené státy, 19145
- CHOP Primary Care - South Philadelphia
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
Ne starší než 2 roky (Dítě)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Age birth to 30 months of age by the start of the intervention phase.
- Child's Primary Care Physician has consented to participate in the study
- Parental/guardian permission (informed consent).
Exclusion Criteria:
- Premature Infants (less than 36 weeks of gestation)
- Children with prior identified developmental delay.
- Children with major congenital anomalies/genetic disorders
- Children placed in foster care
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Promítání
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: SRS
School Readiness Specialist (SRS) will administer the screening questionnaire to the subject during the intervention period, at the subject's 9, 18, 24 and 30 month visits.
They will then see their PCP for a well child visit in which the results of the test will be interpreted, developmental counseling and/or anticipatory guidance provided as per usual care.
EI (Early intervention) referral will be completed, at the discretion of the providers, if the subject fails the developmental screen or the caregivers raise a specific concern about the child's development.
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In the SRS intervention arm subjects will complete developmental screening tools with a school readiness specialist at their 9, 18, 24 and 30 month well child visits and then complete their well child visit with their primary care clinician to discuss the results.
Subjects who are randomized to PCP arm will be screened for developmental delays by their Primary Care Clinician at their 9, 18, 24 and 30 month well child visits.
The corresponding screening tools may be mailed to the study participants 2 weeks before the scheduled well child visits.
Those who do not complete the screening tools or those who did not receive them in the mail will then complete the questionnaire in the office prior to seeing their doctor or with their doctor.
The PCP will then score the screening tool and interpret the test results.
Developmental counseling and/or anticipatory guidance will be provided, as per usual care.
EI referral will be completed, at the discretion of the provider with the approval of the caregiver , if the subject fails the developmental screen or the caregivers raise a specific concern about the child's development.
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Experimentální: Provider
Primary Care Physician (PCP) will do the developmental screening at the subject's 9, 18, 24 and 30 month well child visits.
Once the screening questionnaire is complete the PCP will then score the screening tool and interpret the test results.
Developmental counseling and/or anticipatory guidance will be provided, as per usual care.
EI (Early intervention) referral will be completed, at the discretion of the providers, if the subject fails the developmental screen or the caregivers raise a specific concern about the child's development.
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In the SRS intervention arm subjects will complete developmental screening tools with a school readiness specialist at their 9, 18, 24 and 30 month well child visits and then complete their well child visit with their primary care clinician to discuss the results.
Subjects who are randomized to PCP arm will be screened for developmental delays by their Primary Care Clinician at their 9, 18, 24 and 30 month well child visits.
The corresponding screening tools may be mailed to the study participants 2 weeks before the scheduled well child visits.
Those who do not complete the screening tools or those who did not receive them in the mail will then complete the questionnaire in the office prior to seeing their doctor or with their doctor.
The PCP will then score the screening tool and interpret the test results.
Developmental counseling and/or anticipatory guidance will be provided, as per usual care.
EI referral will be completed, at the discretion of the provider with the approval of the caregiver , if the subject fails the developmental screen or the caregivers raise a specific concern about the child's development.
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Žádný zásah: Routine
Subjects randomized to routine surveillance will receive routine preventive care as well as developmental surveillance at all well child visits, including the 9, 18, 24 and 30 month visits.
EI referral will be completed, at the discretion of the provider, if the PCP observes a developmental delay during surveillance or the caregivers raise a specific concern about the child's development.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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The primary outcome measure for this study will be the percentage of children enrolled in the study who are identified as having a developmental delay.
Časové okno: We assessed this between June to October 2010
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We assessed this between June to October 2010
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
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Percentage of children in the study who are referred to Early Intervention Services
Časové okno: We assessed this in June 2010
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We assessed this in June 2010
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Percentage of children in the study who enroll in Early Intervention Services
Časové okno: We will assess this between June to October 2010
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We will assess this between June to October 2010
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Percent of parents enrolled in the study who report as satisfied with the intervention
Časové okno: We assessed this between March and September 2010
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We assessed this between March and September 2010
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Percent of providers enrolled in the study who report as satisfied with the intervention.
Časové okno: We will assess this between March and September 2010
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We will assess this between March and September 2010
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: James P Guevara, MD MPH, Children's Hospital of Philadelphia
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. listopadu 2008
Primární dokončení (Aktuální)
1. října 2010
Dokončení studie (Aktuální)
1. října 2010
Termíny zápisu do studia
První předloženo
13. února 2009
První předloženo, které splnilo kritéria kontroly kvality
13. února 2009
První zveřejněno (Odhad)
16. února 2009
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
10. listopadu 2011
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
8. listopadu 2011
Naposledy ověřeno
1. listopadu 2011
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 2008-9-6124
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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