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Cradling Our Future Through Family Strengthening Study

9. ledna 2015 aktualizováno: Allison Barlow, Johns Hopkins Bloomberg School of Public Health

In-home Prevention of SA Risks for Native Teen Families

The purpose of this study is to determine whether an in-home, paraprofessional-delivered family strengthening curriculum entitled Family Spirit is effective at increasing parental competence, improving maternal outcomes and improving childhood outcomes in a sample of at-risk teen mothers living in four Native American reservation communities. The effectiveness of the Family Spirit curriculum will be determined by comparing outcomes of mothers who receive the intervention plus assisted transportation to prenatal and well baby visits (called Optimal Standardized Care) to mothers who receive only Optimal Standardized Care. Outcomes will be assessed at multiple intervals over the course of a 39-month study period.

Přehled studie

Detailní popis

American Indians (AIs) in reservation communities have the poorest health, education and socioeconomic status of any racial or ethnic group in the U.S., placing AI youth at increased risk for drug abuse (alcohol, marijuana, tobacco, etc.) and adverse health and behavior outcomes. This study focuses on one of the most vulnerable groups of reservation-based AIs-AI teen mothers and their children.

Over the past two decades a number of research-based health promotion and drug abuse prevention programs for youth have been found to be effective. Of these, parenting interventions have been found to be more effective than other types of interventions. Home visiting programs for young, high-risk mothers have been designed to impact a wide range of outcomes--parenting, child and maternal health and behavior outcomes. More than 40 studies have been published since 1982 supporting the short and long-term efficacy of home visiting programs delivered during pregnancy and early childhood for low-income families. Positive outcomes have been demonstrated for improved parenting and the home environment; increased social support for mothers and children from extended family members and improved maternal health and behavior outcomes; increased birth spacing; improved children's health and behavior outcomes; prevention of child abuse and neglect; and reduced drug use.

AI teen mothers and their offspring are arguably the most vulnerable and underserved population at risk for drug abuse and adverse health and behavior outcomes in the U.S. Given their high-risk status, pregnant AI teens are likely to benefit from a parenting-focused, home visiting intervention. Cultural support for developing individual strengths through a family-based model and the noted cultural relevance of employing AI paraprofessionals are expected to enhance participants' outcomes. As nearly half of AI women begin child-bearing in adolescence, improvement in outcomes of teen mothers and their offspring could substantially impact the public health and welfare of AI communities.

Both nurses and paraprofessionals have been utilized in effective home visiting programs. However, the shortage of indigenous nurses in reservation communities renders an AI nurse-delivered, home visiting intervention unfeasible for the participating communities at this time. Further, young AI women's discomfort with health care delivered by non-Indians and the potential for cultural barriers with non-Indian home visitors provides an additional rationale for AI paraprofessionals as home visitors.

Successful home visiting programs maintain a standard for frequency and dosage of visits, employ strategies for participant retention, provide intensive training, frequent direct supervision and intensive quality assurance measures. For this study, we will maintain the highest standards for dosage, retention strategies, home visitor training and supervision, and quality assurance. The core content of the curriculum is based on American Academy of Pediatrics' comprehensive guidelines for preparing mothers to care for infants and young children, with cultural adaptations derived through guidance from our Native Advisory Board and an iterative process of community input.

Typ studie

Intervenční

Zápis (Aktuální)

322

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Arizona
      • Fort Defiance, Arizona, Spojené státy, 86540
        • Johns Hopkins Center for American Indian Health
      • San Carlos, Arizona, Spojené státy, 85550
        • Johns Hopkins Center for American Indian Health
      • Tuba City, Arizona, Spojené státy, 86045
        • Johns Hopkins Center for American Indian Health
      • Whiteriver, Arizona, Spojené státy, 85941
        • Johns Hopkins Center for American Indian Health
    • Maryland
      • Baltimore, Maryland, Spojené státy, 21205
        • Johns Hopkins Center for American Indian Health

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

12 let až 19 let (Dítě, Dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Ženský

Popis

Inclusion Criteria:

  • Pregnant AI females aged 12 to 19 years old at time of conception.
  • Gestational age of 28 weeks or less (in order to complete intervention prior to delivery).
  • Parent/guardian consent for youth under 18 years old.
  • Reside within 1-hour transportation range (50 miles) of the local Indian Health Service medical facility.

Exclusion Criteria:

  • Current participation in other mental or behavior health research project.
  • Factors that preclude full participation, identified at baseline and after caseness review, including: unstable and severe medical, psychiatric or drug use problem; acute suicidal or homicidal ideation requiring immediate intervention; recent, severe stressful life event such as physical or sexual abuse, or victim of a violent crime that requires specific and high intensity intervention or out of home placement; or chronic pattern of unstable caretakers or living situation.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Family Spirit Intervention
The Family Spirit Intervention included 43 structured lessons and followed a culturally congruent format. Positive parenting lessons were focused on reducing behaviors (i.e., poor monitoring; coercive interactions;harsh, unresponsive, or rejecting parenting; and abuse/ neglect) associated with early childhood behavior problems, including externalizing, internalizing, and dysregulation problems.
The Family Spirit Intervention was developed over a decade through community-based participatory research.The intervention content included 43 structured lessons and followed a culturally congruent format.
Žádný zásah: Optimized Standard Care Control Group
Optimized standard care consisted of transportation to recommended prenatal and well-baby clinic visits, pamphlets about child care and community resources, and referrals to local services. It also addressed access barriers to health care for young mothers and children, and it overcame concerns that home-visiting programs have operated in parallel, not in partnership, with pediatric care. Family health liaisons conducted the optimized standard care and were not trained in the Family Spirit intervention, to avoid contamination of the control condition.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Časové okno
Increase in parental competence at nine intervals over 39 month study period
Časové okno: birth-3 year postpartum
birth-3 year postpartum

Sekundární výstupní opatření

Měření výsledku
Časové okno
Differences in social and emotional competence, and internalizing, externalizing and regulatory problems for children between ages 12-36 months
Časové okno: birth-3 year postpartum
birth-3 year postpartum
Moderators and mediators of intervention response for mothers and children.
Časové okno: birth-3 year postpartum
birth-3 year postpartum
Increase in maternal outcomes at nine intervals over 39 month study period
Časové okno: birth-3 year postpartum
birth-3 year postpartum
Improved childhood outcomes at nine intervals over 39 month study period
Časové okno: birth-3 year postpartum
birth-3 year postpartum

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: John Walkup, MD, Johns Hopkins University
  • Ředitel studie: Allison Barlow, MA, MPH, Johns Hopkins Center for American Indian Health

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. června 2006

Primární dokončení (Aktuální)

1. prosince 2010

Dokončení studie (Aktuální)

1. prosince 2010

Termíny zápisu do studia

První předloženo

7. září 2006

První předloženo, které splnilo kritéria kontroly kvality

7. září 2006

První zveřejněno (Odhad)

8. září 2006

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

12. ledna 2015

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

9. ledna 2015

Naposledy ověřeno

1. ledna 2015

Více informací

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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