Evaluation of the Healthy Families Alaska Program

August 29, 2017 updated by: Johns Hopkins University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

380

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99503
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From child's birth (baseline) to 24 months of age
Child Development
Time Frame: 24 months
Child cognitive, motor and psychosocial development
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From child's birth (baseline) to 24 months of age
Maternal Life Course
Time Frame: At time of study follow-up (child 24 months of age)
Educational attainment, employment, social support, rapid repeat birth
At time of study follow-up (child 24 months of age)
Maternal Psychosocial Functioning
Time Frame: At time of study follow-up (child 24 months of age)
Mental health, substance use, intimate partner violence
At time of study follow-up (child 24 months of age)
Parenting Knowledge
Time Frame: At time of study follow-up (child 24 months of age)
Knowledge of child development; recognition of child delay
At time of study follow-up (child 24 months of age)
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
At time of study follow-up (child 24 months of age)
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
At time of study follow-up (child 24 months of age)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

State of Alaska Department of Health and Social Services

Investigators

  • Principal Investigator: Anne K Duggan, ScD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1999

Primary Completion (Actual)

February 21, 2004

Study Completion (Actual)

January 21, 2005

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Actual)

August 30, 2017

Last Update Submitted That Met QC Criteria

August 29, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 99-0155
  • Contract Number 067727

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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