NCT00216710

Brief Summary

This study will assess the effectiveness of early home visitation by a professional in preventing child maltreatment, promoting healthy family functioning, and promoting child health and development. The investigators will test the following hypotheses regarding the effectiveness of early paraprofessional home visiting for at-risk families

  • Actual home visiting services adhere to HFAK standards.
  • HFAK promotes healthy family functioning, promotes child health and development, and prevents child abuse and neglect.
  • Adherence to HFAK process standards is positively associated with achievement of outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
380

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 1999

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1999

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2004

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2005

Completed
8 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

August 30, 2017

Status Verified

August 1, 2017

Enrollment Period

4.6 years

First QC Date

September 16, 2005

Last Update Submit

August 29, 2017

Conditions

Child Abuse

Keywords

Child abuseNeglectHome visitationProgram evaluation

Outcome Measures

Primary Outcomes (2)

  • Child Abuse and Neglect

    Substantiated and unsubstantiated reports of abuse; maternal self-report of harsh discipline

    From child's birth (baseline) to 24 months of age

  • Child Development

    Child cognitive, motor and psychosocial development

    24 months

Secondary Outcomes (6)

  • Child Health

    From child's birth (baseline) to 24 months of age

  • Maternal Life Course

    At time of study follow-up (child 24 months of age)

  • Maternal Psychosocial Functioning

    At time of study follow-up (child 24 months of age)

  • Parenting Knowledge

    At time of study follow-up (child 24 months of age)

  • Parenting Attitudes

    At time of study follow-up (child 24 months of age)

  • +1 more secondary outcomes

Study Arms (2)

Home Visited Mothers

EXPERIMENTAL

Mothers randomized to the home visited group received AK State-funded home visiting services. Frequency of home visits was determined by home visiting staff based on mothers' needs. Mothers could receive home visiting services until their child turned 3 years old

Behavioral: Home Visiting

Control Mothers

NO INTERVENTION

Mothers randomized to the control group did not receive home visiting services, but were offered referrals to other community-based services, as was usual protocol with home visiting agencies were operating at capacity.

Interventions

Home VisitingBEHAVIORAL
Home Visited Mothers

Eligibility Criteria

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

You may qualify if:

  • Family resides in a community served by one of six HFAK programs participating in the study
  • Family identified as at-risk by HFAK staff following the usual HFAK protocol

You may not qualify if:

  • Family was previously enrolled in HFAK
  • Mother unable to speak English well enough to complete study activities.
  • Family unwilling to enroll in the HFAK program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Anchorage, Alaska, 99503, United States

Location

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
not applicable
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

July 1, 1999

Primary Completion

February 21, 2004

Study Completion

January 21, 2005

Last Updated

August 30, 2017

Record last verified: 2017-08

Locations

US(1)