Clinical trial NCT00216710: Evaluation of the Healthy Families Alaska Program
Official title: Evaluation of the Healthy Families Alaska Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Abuse
Keywords: Child abuse
Neglect
Home visitation
Program evaluation
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: State of Alaska Department of Health and Social Services
First posted: 2005-09-22
Enrollment: 380
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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 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.

Primary outcomes:
measure: Child Abuse and Neglect
timeFrame: From child's birth (baseline) to 24 months of age
measure: Child Development
timeFrame: 24 months
Secondary outcomes:
measure: Child Health
timeFrame: From child's birth (baseline) to 24 months of age
measure: Maternal Life Course
timeFrame: At time of study follow-up (child 24 months of age)
measure: Maternal Psychosocial Functioning
timeFrame: At time of study follow-up (child 24 months of age)
measure: Parenting Knowledge
timeFrame: At time of study follow-up (child 24 months of age)
measure: Parenting Attitudes
timeFrame: At time of study follow-up (child 24 months of age)
measure: Parenting Behavior
timeFrame: At time of study follow-up (child 24 months of age)
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Johns Hopkins University
state: Alaska
Study officials:
affiliation: Johns Hopkins University
name: Anne K Duggan, ScD
role: PRINCIPAL_INVESTIGATOR
References: