- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01098695
Early Family-Centered Prevention of Drug Use Risk (Aka Early Steps) (Early Steps)
Early Family-Centered Prevention of Drug Use Risk
The investigators are testing the efficacy of a family-based preventive intervention, which began when the children were age 2, with children at risk for developing significant conduct problems. Families who were originally recruited from Women, Infants and Children (WIC) were randomly assigned to a family-centered intervention developed by Dishion and colleagues (Dishion & Kavanagh, 2003; Dishion & Stormshak, 2006) referred to as an 'ecological approach to family intervention and treatment' (EcoFIT). The current study expands the Early Steps intervention into the elementary school years beyond what is currently available for a WIC service delivery venue, in which children are no longer eligible for services at age 6.
The investigators are testing the hypothesis that periodic, tailored, and adaptive interventions delivered to caregivers at school entry will (a) reduce the probability of elevated risk associated with early-onset problem behavior, including the eventual use of drugs and other health-risking behaviors; (b) reduce the likelihood of mental health problems such as childhood depression, anxiety, conduct problems and co-morbidity; and (c) promote children's development of self-regulation, which underlies school readiness, early school literacy academic achievement, and positive peer relations.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Aims of the current project are:
- Refine the intervention model to address the child's adaptation to school and development of self-regulatory skills and underlying multiple dimensions of school success.
- Examine and test the consistency of developmental models of problem behavior, emotional adjustment, and normative self-regulation in childhood.
- Evaluate the long-term impact of intervention on risk pathways to later drug abuse and health-risking behaviors by examining early risk markers, including children's problem behavior, poor emotional adjustment, and lack of school readiness.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Oregon
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Eugene, Oregon, Spojené státy, 97401
- University of Oregon-Child and Family Center
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, Spojené státy, 15260
- University of Pittsburgh
-
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Virginia
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Charlottesville, Virginia, Spojené státy, 22904
- University of Virginia
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Original Inclusion Criteria:
- Parents with children between ages two and three
- Currently enrolled with Women, Infants, and Children (WIC)
- To qualify for the original study, families needed to meet criteria for child, family, and sociodemographic risk. Specifically, families either had to meet "child risk" factors or they had to have at least two of the three factors present to qualify for the study. To meet criterion for child risk, scores must be at least one SD above the normative average on the Eyberg Intensity of Problems factors, the Bates difficulty (i.e. negative emotionality) factor, or the conflict factor of the Adult-Child Relationship Scale. Family risk was determined by a score of one SD above the normative average on maternal depressive symptoms or parenting daily hassles, having substance use/abuse problems, or teen parent status. Sociodemographic risk was established using educational attainment because all WIC participants met criteria for low income. Families in which educational attainment is less than three years of college for both parents satisfied the requirement of sociodemographic risk.
Studijní plán
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: EcoFIT offered
|
Includes the Family Check-Up (in-person intake, family video observations and Assessment questionnaires used to provide and tailored feedback using motivational interviewing techniques) as well as continued tailored intervention services using the Everyday Parenting Curriculum.
Ostatní jména:
|
Žádný zásah: No Feedback or services offered
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Home visit assessment
Časové okno: yearly
|
Includes caregiver assessment packets (including CBCL, Eyberg, Rothbart Effortful Control scales, CESD-D, parental substance use, Adult-Child Relationship scale), child assessment (including DIBELS and Woodcock-Johnson) and Parent-Child videotaped interactions.
|
yearly
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Thomas J Dishion, PhD, University of Oregon- Child and Family Center
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 3R01DA016110 (Grant/smlouva NIH USA)
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 .