Evaluation of the Healthy Families Alaska Program

Child Abuse Clinical Trial

Official title:

Evaluation of the Healthy Families Alaska Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00216710
• Other study ID #: 99-0155
• Secondary ID: Contract Number
• Status: Completed
• Phase: N/A
• First received: September 16, 2005
• Last updated: August 29, 2017
• Start date: July 1999
• Est. completion date: January 21, 2005

Study information

• Verified date: August 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: January 21, 2005
• Est. primary completion date: February 21, 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Child Abuse

Intervention

Behavioral:
• Home Visiting

Locations

Country	Name	City	State
United States	Johns Hopkins University	Anchorage	Alaska

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	State of Alaska Department of Health and Social Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Child Development	Child cognitive, motor and psychosocial development	24 months
Secondary	Child Health	Hospitalizations, ED use, injuries requiring medical care, adequate well child care, immunizations	From child's birth (baseline) to 24 months of age
Secondary	Maternal Life Course	Educational attainment, employment, social support, rapid repeat birth	At time of study follow-up (child 24 months of age)
Secondary	Maternal Psychosocial Functioning	Mental health, substance use, intimate partner violence	At time of study follow-up (child 24 months of age)
Secondary	Parenting Knowledge	Knowledge of child development; recognition of child delay	At time of study follow-up (child 24 months of age)
Secondary	Parenting Attitudes	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)
Secondary	Parenting Behavior	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)