Viewing Study NCT00218751



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Last Modification Date: 2024-10-26 @ 9:19 AM
Study NCT ID: NCT00218751
Status: COMPLETED
Last Update Posted: 2013-09-24
First Post: 2005-09-16

Brief Title: Early Home Visitation Program to Promote Good Health and Development in Children at Risk for Abuse
Sponsor: Johns Hopkins University
Organization: Johns Hopkins University

Study Overview

Official Title: Promoting Child Mental Health RCT of Home Visiting
Status: COMPLETED
Status Verified Date: 2008-02
Last Known Status: None
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 the effectiveness of Hawaiis Healthy Start Program HSP a home visitation program for families at risk for child abuse in promoting the health and development of children
Detailed Description: Hawaiis Healthy Start Program HSP is a well-respected home visiting program for families at risk for abuse of their newborn children The program incorporates early identification of at-risk families Each family then begins receiving long-term home visitations The home visiting component aims to promote child health and development and to prevent child abuse by improving family functioning and parenting Home visitors are trained paraprofessionals working under professional supervision The program includes both direct services and referrals to community resources Direct services include providing emotional support to parents encouraging them to seek needed professional help teaching parents about child development and role-modeling parenting skills and problem-solving techniques In a previous study at-risk families were randomly assigned to either HSP or no intervention Evaluations were conducted at the time of the childs birth and at ages 1 2 and 3 in order to assess the home environment and the development and well-being of the child This study is a continuation study Participants will include the original families from the previous study as well as a new group of families who are not at risk for child abuse By interviewing and observing these two groups of families this study will evaluate the effectiveness of HSP in promoting childrens mental health cognitive and social-emotional development and academic achievement in the first years of school

All families will be evaluated on a yearly basis when the child is in 1st 2nd and 3rd grade Interviews will be conducted with the parents children and teachers Parent interviews will focus on family functioning including mental health of the parents parenting attitudes and behaviors quality of the home environment and any domestic violence or substance abuse that occurred In addition the childs health and development as well as use of any community resources will be assessed Interviews with the children and teachers will focus on assessing the childs behavior and emotional well-being The familys home environment the interaction between the parents and children and the childrens classroom behavior will be observed Each child will also undergo developmental testing All measurements will be collected at each yearly visit

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
Secondary IDs
Secondary ID Type Domain Link
DSIR CT-P US NIH GrantContract None httpsreporternihgovquickSearchR01MH060733
R01MH060733 NIH None None