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Evaluation of the Healthy Families Alaska Program

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00216710
First Posted: September 22, 2005
Last Update Posted: August 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
State of Alaska Department of Health and Social Services
Information provided by:
Johns Hopkins University
  Purpose

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.

Condition Intervention
Child Abuse Behavioral: Home Visiting

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of the Healthy Families Alaska Program

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Child Abuse and Neglect [ Time Frame: From child's birth (baseline) to 24 months of age ]
    Substantiated and unsubstantiated reports of abuse; maternal self-report of harsh discipline

  • Child Development [ Time Frame: 24 months ]
    Child cognitive, motor and psychosocial development


Secondary Outcome Measures:
  • Child Health [ Time Frame: From child's birth (baseline) to 24 months of age ]
    Hospitalizations, ED use, injuries requiring medical care, adequate well child care, immunizations

  • Maternal Life Course [ Time Frame: At time of study follow-up (child 24 months of age) ]
    Educational attainment, employment, social support, rapid repeat birth

  • Maternal Psychosocial Functioning [ Time Frame: At time of study follow-up (child 24 months of age) ]
    Mental health, substance use, intimate partner violence

  • Parenting Knowledge [ Time Frame: At time of study follow-up (child 24 months of age) ]
    Knowledge of child development; recognition of child delay

  • Parenting Attitudes [ Time Frame: At time of study follow-up (child 24 months of age) ]
    Use of corporal punishment, infant caregiving, expectations of children, empathy towards child's needs

  • Parenting Behavior [ Time Frame: At time of study follow-up (child 24 months of age) ]
    Observational measures of parent/child interaction and quality of the home environment, use of corporal punishment, use of nonviolent discipline


Enrollment: 380
Study Start Date: July 1999
Study Completion Date: January 21, 2005
Primary Completion Date: February 21, 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Home Visited Mothers
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
No Intervention: Control Mothers
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.

Detailed Description:

Healthy Families Alaska (HFAK) is a well-established child abuse prevention program targeted to at-risk families. HFAK is based on the Healthy Families America initiative promoted by Prevent Child Abuse America. The State Department of Health and Social Services (DHSS) administers the HFAK program.

In 1998, the Alaska State Legislature requested a controlled study of HFAK to determine its effectiveness in preventing child maltreatment, promoting healthy family functioning, and promoting child health and development. DHSS awarded the Johns Hopkins University School of Medicine a contract to conduct the study from July 1999 through June 2004.

The study is a randomized trial of six HFAK sites throughout Alaska. It aims to compare services actually provided to HFAK standards, assess program success in achieving intended outcomes, and relate program impact to service delivery.

Families are enrolled over 21 months beginning in January 2000. Families are randomized to either the HFAk group or the control group. Baseline data on family attributes are collected from HFAK files and maternal interviews. HFAK service data are collected from the program's management information system, record reviews, surveys of staff, and staff focus groups. Outcome data are collected when the children were two years old through maternal interview, home-based observations, child developmental testing, review of medical records, and review of OCS child welfare records.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
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): NCT00216710


Locations
United States, Alaska
Johns Hopkins University
Anchorage, Alaska, United States, 99503
Sponsors and Collaborators
Johns Hopkins University
State of Alaska Department of Health and Social Services
Investigators
Principal Investigator: Anne K Duggan, ScD Johns Hopkins University
  More Information

ClinicalTrials.gov Identifier: NCT00216710     History of Changes
Other Study ID Numbers: 99-0155
Contract Number 067727
First Submitted: September 16, 2005
First Posted: September 22, 2005
Last Update Posted: August 30, 2017
Last Verified: August 2017

Keywords provided by Johns Hopkins University:
Child abuse
Neglect
Home visitation
Program evaluation