Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00110292
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2005-05-05
Brief Title:
Preventing Learning Problems in Young Children A Public Health and Physician-Based Outreach
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
An RCT of a Low-Intensity Intervention to Reduce Delay
Status:
UNKNOWN
Status Verified Date:
2005-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate a program to prevent learning problems in children The program is an inexpensive public health outreach program designed for families living in poverty and is administered through pediatricians offices and clinics
Detailed Description:
This study will assess the effectiveness of a low-intensity low-cost preventive intervention to reduce developmental delay and learning problems in young children The goal is to improve home caregiving environment factors that are often suboptimal in families living in poverty these families are often subject to social economic and medical risk factors The intervention is based on a public healthprimary care partnership and combines mailed parent-completed Ages Stages Questionnaires ASQ a monthly mailed age-paced parenting newsletter Building Blocks and corresponding developmental toys BB and a Reach Out and Read ROR physician-based distribution of childrens books
Families of 4- to 7-month-old children attending a participating pediatric clinic will be randomized to either an ASQBBROR group an ROR-only group or a no intervention control group Outcomes measures will be obtained at 15 24 36 and 48 months of age and include measures of the home environment parenting and parent-child interaction child language and mental development measures and rates of referral to Early Intervention programs Baseline and ongoing demographic information and psychosocial and biological risk factors will also be gathered to see how they relate to child and family outcomes and to determine whether certain subgroups of families are more likely to benefit from the intervention than others
Families of 4- to 7-month-old children attending a participating pediatric clinic will be randomized to either an ASQBBROR group an ROR-only group or a no intervention control group Outcomes measures will be obtained at 15 24 36 and 48 months of age and include measures of the home environment parenting and parent-child interaction child language and mental development measures and rates of referral to Early Intervention programs Baseline and ongoing demographic information and psychosocial and biological risk factors will also be gathered to see how they relate to child and family outcomes and to determine whether certain subgroups of families are more likely to benefit from the intervention than others
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None