Translating Evidence Based Developmental Screening Into Pediatric Primary Care (TEDS)
8 novembre 2011 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
2314
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19104
- CHOP - Primary Care Market Street
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Philadelphia, Pennsylvania, États-Unis, 19104
- CHOP Primary Care-University City
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Philadelphia, Pennsylvania, États-Unis, 19139
- CHOP Primary Care Center- Cobbs Creek
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Philadelphia, Pennsylvania, États-Unis, 19145
- CHOP Primary Care - South Philadelphia
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
Pas plus vieux que 2 ans (Enfant)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Dépistage
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Expérimental: 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.
|
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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Aucune intervention: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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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.
Délai: We assessed this between June to October 2010
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We assessed this between June to October 2010
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Percentage of children in the study who are referred to Early Intervention Services
Délai: 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
Délai: 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
Délai: 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.
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: James P Guevara, MD MPH, Children's Hospital of Philadelphia
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 novembre 2008
Achèvement primaire (Réel)
1 octobre 2010
Achèvement de l'étude (Réel)
1 octobre 2010
Dates d'inscription aux études
Première soumission
13 février 2009
Première soumission répondant aux critères de contrôle qualité
13 février 2009
Première publication (Estimation)
16 février 2009
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
10 novembre 2011
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 novembre 2011
Dernière vérification
1 novembre 2011
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 2008-9-6124
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .