Evaluation of the Healthy Families Alaska Program
| Tracking Information | |||||
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| First Received Date ICMJE | September 16, 2005 | ||||
| Last Updated Date | September 16, 2005 | ||||
| Start Date ICMJE | July 1999 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluation of the Healthy Families Alaska Program | ||||
| Official Title ICMJE | Evaluation of the Healthy Families Alaska Program | ||||
| 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. We will test the following hypotheses regarding the effectiveness of early paraprofessional home visiting for at-risk families
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Child Abuse | ||||
| Intervention ICMJE | Behavioral: Home Visiting | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 380 | ||||
| Completion Date | February 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00216710 | ||||
| Other Study ID Numbers ICMJE | 99-0155, Contract Number 067727 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Johns Hopkins University | ||||
| Collaborators ICMJE | State of Alaska Department of Health and Social Services | ||||
| Investigators ICMJE |
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| Information Provided By | Johns Hopkins University | ||||
| Verification Date | January 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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