The MOM Program: 5 Year Follow-up Study of a Home Visiting Program at The Children's Hospital of Philadelphia (MOM Program)
26. Oktober 2015 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
302
Phase
- Phase 3
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
- The Children's Hospital of Philadelphia
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
4 Jahre bis 5 Jahre (Kind)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Home visiting Intervention
Home visiting intervention group.
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Home visits and telephone calls keyed to well child visits.
|
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Placebo-Komparator: 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
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Februar 2004
Primärer Abschluss (Tatsächlich)
1. Februar 2007
Studienabschluss (Tatsächlich)
1. Februar 2007
Studienanmeldedaten
Zuerst eingereicht
30. September 2005
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
30. September 2005
Zuerst gepostet (Schätzen)
4. Oktober 2005
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
23. November 2015
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
26. Oktober 2015
Zuletzt verifiziert
1. Oktober 2015
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 2003-10-3495
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Nein
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