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

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ClinicalTrials.gov Identifier: NCT00218751
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 24, 2013
National Institute of Mental Health (NIMH)
Information provided by:
Johns Hopkins University

Brief Summary:
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 or disease Intervention/treatment Phase
Child Abuse Behavioral: Home Visiting Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1122 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Promoting Child Mental Health: RCT of Home Visiting
Study Start Date : March 2000
Actual Primary Completion Date : June 2005
Actual Study Completion Date : August 2005

Primary Outcome Measures :
  1. Child cognitive development, behavior, and health [ Time Frame: At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years ]
  2. Child social-emotional development [ Time Frame: At-risk sample: Up to 6 years; Not-at risk sample: Up to 1 year ]
  3. Child depression [ Time Frame: At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years ]

Secondary Outcome Measures :
  1. Family functioning [ Time Frame: At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years ]
  2. Parent functioning and stress levels [ Time Frame: At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years ]
  3. Substantiated reports of child abuse [ Time Frame: At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00218751

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United States, Hawaii
Johns Hopkins University
Honolulu, Hawaii, United States, 96814
Sponsors and Collaborators
Johns Hopkins University
National Institute of Mental Health (NIMH)
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Principal Investigator: Anne K. Duggan, ScD Johns Hopkins University

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ClinicalTrials.gov Identifier: NCT00218751    
Other Study ID Numbers: R01MH060733 ( U.S. NIH Grant/Contract )
R01MH060733 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 24, 2013
Last Verified: February 2008
Keywords provided by Johns Hopkins University:
Child abuse
Home Visitation
Program Evaluation