Early Home Visitation Program to Promote Good Health and Development in Children at Risk for Abuse

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00218751
First received: September 16, 2005
Last updated: September 23, 2013
Last verified: February 2008

September 16, 2005
September 23, 2013
March 2000
June 2005   (final data collection date for primary outcome measure)
  • Child cognitive development, behavior, and health [ Time Frame: At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years ] [ Designated as safety issue: No ]
  • Child social-emotional development [ Time Frame: At-risk sample: Up to 6 years; Not-at risk sample: Up to 1 year ] [ Designated as safety issue: No ]
  • Child depression [ Time Frame: At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years ] [ Designated as safety issue: No ]
  • Child cognitive development, behavior, and health; measured when the child is in 1st, 2nd, and 3rd grades
  • Child social-emotional development; measured when the child is in 1st grade
  • Child depression; measured when the child is in 2nd grade
Complete list of historical versions of study NCT00218751 on ClinicalTrials.gov Archive Site
  • Family functioning [ Time Frame: At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years ] [ Designated as safety issue: No ]
  • Parent functioning and stress levels [ Time Frame: At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years ] [ Designated as safety issue: No ]
  • Substantiated reports of child abuse [ Time Frame: At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years ] [ Designated as safety issue: No ]
  • Family functioning; measured when the child is in 1st, 2nd, and 3rd grades
  • Parent functioning and stress levels; measured when the child is in 1st, 2nd, and 3rd grades
  • Substantiated reports of child abuse; measured when the child is in 1st, 2nd, and 3rd grades
Not Provided
Not Provided
 
Early Home Visitation Program to Promote Good Health and Development in Children at Risk for Abuse
Promoting Child Mental Health: RCT of Home Visiting

This study will evaluate the effectiveness of Hawaii's Healthy Start Program (HSP), a home visitation program for families at risk for child abuse, in promoting the health and development of children.

Hawaii's 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 child's 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 children's 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 child's 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 child's behavior and emotional well-being. The family's home environment, the interaction between the parents and children, and the children's classroom behavior will be observed. Each child will also undergo developmental testing. All measurements will be collected at each yearly visit.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Child Abuse
Behavioral: Home Visiting
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1122
August 2005
June 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Families in the Oahu community who delivered newborns between November 1994 and November 1995
  • If enrolled in the control group, must not have been previously enrolled in Hawaii's Healthy Start Program

Exclusion Criteria:

  • Insufficient understanding of English
Both
14 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00218751
R01 MH60733, R01MH060733, DSIR CT-P
Not Provided
Not Provided
Johns Hopkins University
National Institute of Mental Health (NIMH)
Principal Investigator: Anne K. Duggan, ScD Johns Hopkins University
Johns Hopkins University
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP