NCT00218751

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,122

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2000

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2000

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

September 24, 2013

Status Verified

February 1, 2008

Enrollment Period

5.3 years

First QC Date

September 16, 2005

Last Update Submit

September 23, 2013

Conditions

Child Abuse

Keywords

Child abuseNeglectHome VisitationProgram Evaluation

Outcome Measures

Primary Outcomes (3)

  • Child cognitive development, behavior, and health

    At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years

  • Child social-emotional development

    At-risk sample: Up to 6 years; Not-at risk sample: Up to 1 year

  • Child depression

    At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years

Secondary Outcomes (3)

  • Family functioning

    At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years

  • Parent functioning and stress levels

    At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years

  • Substantiated reports of child abuse

    At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years

Interventions

Home VisitingBEHAVIORAL

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Insufficient understanding of English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Honolulu, Hawaii, 96814, United States

Location

Related Publications (16)

  • Duggan A, Windham A, McFarlane E, Fuddy L, Rohde C, Buchbinder S, Sia C. Hawaii's healthy start program of home visiting for at-risk families: evaluation of family identification, family engagement, and service delivery. Pediatrics. 2000 Jan;105(1 Pt 3):250-9.

    PMID: 10617732BACKGROUND

  • Duggan A, Fuddy L, McFarlane E, Burrell L, Windham A, Higman S, Sia C. Evaluating a statewide home visiting program to prevent child abuse in at-risk families of newborns: fathers' participation and outcomes. Child Maltreat. 2004 Feb;9(1):3-17. doi: 10.1177/1077559503261336.

    PMID: 14870994BACKGROUND

  • Duggan A, McFarlane E, Fuddy L, Burrell L, Higman SM, Windham A, Sia C. Randomized trial of a statewide home visiting program: impact in preventing child abuse and neglect. Child Abuse Negl. 2004 Jun;28(6):597-622. doi: 10.1016/j.chiabu.2003.08.007.

    PMID: 15193851BACKGROUND

  • Duggan A, Fuddy L, Burrell L, Higman SM, McFarlane E, Windham A, Sia C. Randomized trial of a statewide home visiting program to prevent child abuse: impact in reducing parental risk factors. Child Abuse Negl. 2004 Jun;28(6):623-43. doi: 10.1016/j.chiabu.2003.08.008.

    PMID: 15193852BACKGROUND

  • Windham AM, Rosenberg L, Fuddy L, McFarlane E, Sia C, Duggan AK. Risk of mother-reported child abuse in the first 3 years of life. Child Abuse Negl. 2004 Jun;28(6):645-67. doi: 10.1016/j.chiabu.2004.01.003.

    PMID: 15193853BACKGROUND

  • El-Kamary SS, Higman SM, Fuddy L, McFarlane E, Sia C, Duggan AK. Hawaii's healthy start home visiting program: determinants and impact of rapid repeat birth. Pediatrics. 2004 Sep;114(3):e317-26. doi: 10.1542/peds.2004-0618.

    PMID: 15342892BACKGROUND

  • Nelson CS, Higman SM, Sia C, McFarlane E, Fuddy L, Duggan AK. Medical homes for at-risk children: parental reports of clinician-parent relationships, anticipatory guidance, and behavior changes. Pediatrics. 2005 Jan;115(1):48-56. doi: 10.1542/peds.2004-1193.

    PMID: 15629981BACKGROUND

  • King TM, Rosenberg LA, Fuddy L, McFarlane E, Sia C, Duggan AK. Prevalence and early identification of language delays among at-risk three year olds. J Dev Behav Pediatr. 2005 Aug;26(4):293-303. doi: 10.1097/00004703-200508000-00006.

    PMID: 16100502BACKGROUND

  • Stone KE, Burrell L, Higman SM, McFarlane E, Fuddy L, Sia C, Duggan AK. Agreement of injury reporting between primary care medical record and maternal interview for children aged 0-3 years: implications for research and clinical care. Ambul Pediatr. 2006 Mar-Apr;6(2):91-5. doi: 10.1016/j.ambp.2005.10.003.

    PMID: 16530145BACKGROUND

  • Duggan AK, McFarlane EC, Windham AM, Rohde CA, Salkever DS, Fuddy L, Rosenberg LA, Buchbinder SB, Sia CC. Evaluation of Hawaii's Healthy Start Program. Future Child. 1999 Spring-Summer;9(1):66-90; discussion 177-8.

    PMID: 10414011BACKGROUND

  • Bair-Merritt MH, Jennings JM, Chen R, Burrell L, McFarlane E, Fuddy L, Duggan AK. Reducing maternal intimate partner violence after the birth of a child: a randomized controlled trial of the Hawaii Healthy Start Home Visitation Program. Arch Pediatr Adolesc Med. 2010 Jan;164(1):16-23. doi: 10.1001/archpediatrics.2009.237.

    PMID: 20048237BACKGROUND

  • McFarlane E, Dodge RA, Burrell L, Crowne S, Cheng TL, Duggan AK. The importance of early parenting in at-risk families and children's social-emotional adaptation to school. Acad Pediatr. 2010 Sep-Oct;10(5):330-7. doi: 10.1016/j.acap.2010.06.011.

    PMID: 20816655BACKGROUND

  • Crowne SS, Juon HS, Ensminger M, Burrell L, McFarlane E, Duggan A. Concurrent and long-term impact of intimate partner violence on employment stability. J Interpers Violence. 2011 Apr;26(6):1282-304. doi: 10.1177/0886260510368160. Epub 2010 Jun 28.

    PMID: 20587457BACKGROUND

  • Crowne SS, Gonsalves K, Burrell L, McFarlane E, Duggan A. Relationship between birth spacing, child maltreatment, and child behavior and development outcomes among at-risk families. Matern Child Health J. 2012 Oct;16(7):1413-20. doi: 10.1007/s10995-011-0909-3.

    PMID: 22057656BACKGROUND

  • Bair-Merritt MH, Ghazarian SR, Burrell L, Duggan A. Patterns of Intimate Partner Violence in Mothers At-Risk for Child Maltreatment. J Fam Violence. 2012 May 1;27(4):287-294. doi: 10.1007/s10896-012-9431-7. Epub 2012 Mar 23.

    PMID: 22942558BACKGROUND

  • McFarlane E, Burrell L, Crowne S, Cluxton-Keller F, Fuddy L, Leaf PJ, Duggan A. Maternal relationship security as a moderator of home visiting impacts on maternal psychosocial functioning. Prev Sci. 2013 Feb;14(1):25-39. doi: 10.1007/s11121-012-0297-y.

    PMID: 23104075BACKGROUND

MeSH Terms

Interventions

House Calls

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Anne K. Duggan, ScD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

March 1, 2000

Primary Completion

June 1, 2005

Study Completion

August 1, 2005

Last Updated

September 24, 2013

Record last verified: 2008-02

Locations

US(1)