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Evaluation of the Healthy Families Alaska Program

29 augusti 2017 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

380

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Alaska
      • Anchorage, Alaska, Förenta staterna, 99503
        • Johns Hopkins University

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Kvinna

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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
Beteende: Hembesök
Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Child Abuse and Neglect
Tidsram: 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
Tidsram: 24 months
Child cognitive, motor and psychosocial development
24 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Child Health
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Johns Hopkins University

Samarbetspartners

State of Alaska Department of Health and Social Services

Utredare

  • Huvudutredare: Anne K Duggan, ScD, Johns Hopkins University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 1999

Primärt slutförande (Faktisk)

21 februari 2004

Avslutad studie (Faktisk)

21 januari 2005

Studieregistreringsdatum

Först inskickad

16 september 2005

Först inskickad som uppfyllde QC-kriterierna

16 september 2005

Första postat (Uppskatta)

22 september 2005

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

30 augusti 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 augusti 2017

Senast verifierad

1 augusti 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • 99-0155
  • Contract Number 067727

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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