The MOM Program: 5 Year Follow-up Study of a Home Visiting Program at The Children's Hospital of Philadelphia (MOM Program)
26 ottobre 2015 aggiornato da: Children's Hospital of Philadelphia
The MOM Program Continuation - 5 Year Follow-up
The purpose of the MOM Program Continuation is to promote child development by helping families become more competent in accessing and using available health, developmental and educational resources.
The program focuses are childhood immunizations, Early Intervention services, lead screening, Early Head Start and Head Start enrollment.
The Intervention consists of frequent phone calls and home visits to encourage mothers to have their babies immunized on schedule and to participate in needed developmental and educational services.
The program seeks to fill the gap between children's need for services and mothers' ability to assure their children's participation in those services.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The MOM Program Continuation builds on the work of The MOM Program, a 3 year randomized intervention.
The premise of the MOM Program was that professional support through home visits and frequent phone contacts would improve children's cognitive and behavioral development, ultimately improving their early educational success.
The children were enrolled in the MOM Program at birth.
The MOM Program Continuation provides continued intervention for the children and mothers of the original cohort to assure that the children are prepared for kindergarten entry at 5 years of age and to evaluate the children's cognitive and behavioral outcomes at age 5 years.
The program will also create a longitudinal database to study the linkages between maternal cognitive ability and child cognitive, educational, and behavioral outcomes through entry into school.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
302
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Stati Uniti, 19104
- The Children's Hospital of Philadelphia
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 4 anni a 5 anni (Bambino)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria: Previous enrollment in The MOM Program; child age of 5 years (plus or minus 3 months); willingness to come to office for follow-up assessment visit; parental consent and child assent.
Exclusion Criteria: None.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Home visiting Intervention
Home visiting intervention group.
|
Home visits and telephone calls keyed to well child visits.
|
|
Comparatore placebo: Control
Control condition did not receive any services.
|
The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations.
They were called every 4 months to maintain contact information
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III)
Lasso di tempo: 5 years of age (plus or minus 1 month)
|
Cognitive ability was assessed through the Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III).
The WPPSI-III has been developed and standardized for children ages 2 years, 6 months through 7 years, 3 months of age.
The WPPSI-III yields a Verbal Score, a Performance Score, a General Language Score, and a Full Scale Score.
These scores have a mean of 100 and a standard deviation of 15.
The range of possible values is 50 (worst value) to 150 (best value).
|
5 years of age (plus or minus 1 month)
|
|
Child Behavior Checklist Internalizing Scale at 5 Years of Age, Percentage of Participants
Lasso di tempo: at child age of 5 years (plus or minus 1 month)
|
Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA).
The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems.
Respondents are asked to rate 99 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child" based on the past two months.
The range of possible values is 0-100.
Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).
|
at child age of 5 years (plus or minus 1 month)
|
|
Child Behavior Checklist Externalizing Scale, Percentage of Abnormality in Participants
Lasso di tempo: at child age of 5 years (plus or minus 1 month)
|
Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA).
The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems.
Respondents are asked to rate 99 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child" based on the past two months.
The range of possible values is 0-100.
Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).
|
at child age of 5 years (plus or minus 1 month)
|
|
Child Behavior Checklist Aggressive Subscale, Percentage of Abnormality in Participants
Lasso di tempo: at child age of 5 years (plus or minus 1 month)
|
Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA).
The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems.
Respondents are asked to rate 99 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child" based on the past two months.
The range of possible values is 0-100.
Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).
|
at child age of 5 years (plus or minus 1 month)
|
|
Child Behavior Checklist Attention Subscale, Percentage of Abnormality in Participants
Lasso di tempo: child age 5 years (plus or minus 1 month)
|
Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA).
The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems.
Respondents are asked to rate 99 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child" based on the past two months.
The range of possible values is 0-100.
Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).
|
child age 5 years (plus or minus 1 month)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 febbraio 2004
Completamento primario (Effettivo)
1 febbraio 2007
Completamento dello studio (Effettivo)
1 febbraio 2007
Date di iscrizione allo studio
Primo inviato
30 settembre 2005
Primo inviato che soddisfa i criteri di controllo qualità
30 settembre 2005
Primo Inserito (Stima)
4 ottobre 2005
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
23 novembre 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
26 ottobre 2015
Ultimo verificato
1 ottobre 2015
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 2003-10-3495
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .