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
  Purpose

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.


Condition Intervention Phase
Child Abuse
Behavioral: Home Visiting
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Promoting Child Mental Health: RCT of Home Visiting

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1122
Study Start Date: March 2000
Study Completion Date: August 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218751

Locations
United States, Hawaii
Johns Hopkins University
Honolulu, Hawaii, United States, 96814
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Anne K. Duggan, ScD Johns Hopkins University
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00218751     History of Changes
Other Study ID Numbers: R01 MH60733, R01MH060733, DSIR CT-P
Study First Received: September 16, 2005
Last Updated: September 23, 2013
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins University:
Child abuse
Neglect
Home Visitation
Program Evaluation

ClinicalTrials.gov processed this record on September 18, 2014