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Home visiting professional support model, Control

Phase 3

Child Development | Unknown | Other |Johnson & Johnson|Last Updated: Nov 23, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment302
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00231179The MOM Program: 5 Year Follow-up Study of a Home Visiting Program at The Children's Hospital of PhiladelphiaPHASE3 COMPLETED 302Feb 1, 2004Feb 1, 2007Nov 23, 20151 United States
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Study Endpoints
Primary Endpoints
Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III)
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).

Child Behavior Checklist Internalizing Scale at 5 Years of Age, Percentage of Participants
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).

Child Behavior Checklist Externalizing Scale, Percentage of Abnormality in Participants
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).

Child Behavior Checklist Aggressive Subscale, Percentage of Abnormality in Participants
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).

Child Behavior Checklist Attention Subscale, Percentage of Abnormality in Participants
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).

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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Home visiting InterventionEXPERIMENTALHome visiting intervention group.
ControlPLACEBO_COMPARATORControl condition did not receive any services.
Interventions
NameTypeDescription
Home visiting professional support modelBEHAVIORALHome visits and telephone calls keyed to well child visits.
ControlOTHERThe 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
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Eligibility Criteria
Age Range4 Years — 5 Years
SexALL
Healthy VolunteersYes
Study Sites1

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.

Countries:United States
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