- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01549561
Preventing Behavior and Health Problems in Foster Teens (KEEP2)
7. april 2014 opdateret af: Oregon Social Learning Center
The primary goal of this study is to test the efficacy of two levels of the KEEP intervention with adolescents and their foster and kin parents in the San Diego Child Welfare System.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The cost of child welfare services in the U.S. has been estimated at $20 billion per year.
During the past decade, the number of teenagers in foster care has nearly doubled.
Numerous studies have documented that these adolescents are at high-risk for developing serious problems, including substance use, participation in health-risking sexual behaviors, involvement in the juvenile justice system, serious educational problems and school drop-out, failed placements/foster care "drift" and homelessness.
Yet, there is little research on the characteristics of interventions that can be used to guide the improvement of services for this vulnerable population of youngsters.
The proposed study extends our previous research with adolescents referred for serious behavioral and emotional problems and research with elementary-aged children in foster care to a test of the efficacy of a preventive intervention for adolescents placed with foster and kin care providers in the San Diego County Child Welfare System.
Two hundred and forty adolescents and their foster/kin care providers will participate (i.e., 60 in a foster/kin parent training only condition, 60 in a parent training plus youth skill training condition, and 120 in a casework "as usual" control condition).
In addition to testing the efficacy of the two levels of intervention, the investigators propose to examine the effects of the intervention on a set of youth behavioral and health-related outcomes.
Parenting mediators to be tested include positive parenting, parental supervision, and non-harsh discipline.
Youth mediators are social competence, commitment to school, and knowledge about norms related to health-risking behaviors including substance use and high-risk sexual behavior.
In addition, theoretical hypotheses about the effects of early risk/adversity factors to youth outcomes will be examined, and an economic analysis will be conducted to examine the relative benefits and costs associated with the two levels of intervention.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
259
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
-
San Diego, California, Forenede Stater, 92123
- Child and Adolescent Services Research Center
-
-
Oregon
-
Eugene, Oregon, Forenede Stater, 97401
- Oregon Social Learning Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
12 år til 16 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Any child between ages 12 and 16 years in relative or non-relative foster care
Exclusion Criteria:
- Only medically fragile children
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Services As Usual
Foster care services as usual
|
|
Eksperimentel: Parent and Youth Training
16 Weeks of Parent Training in group context with 5 to 10 relative and non-relative foster caregivers; Youth training with skills coaches
|
16 weeks of parent training led by a trained group facilitator
Andre navne:
16 weeks of one-on-one sessions with a trained youth skills coach
Andre navne:
|
Eksperimentel: Parent Training
16 weeks of parent training with 5 to 10 relative and non-relative foster caregivers
|
16 weeks of parent training led by a trained group facilitator
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Reduction in child behavior problems as assessed by the Parent Daily Report (PDR)
Tidsramme: Baseline, 6 Months, 12 Months, 18 Months
|
Baseline, 6 Months, 12 Months, 18 Months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Placement Disruptions from Foster Placement
Tidsramme: 6 Months, 12 Months, 18 Months
|
6 Months, 12 Months, 18 Months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Patricia Chamberlain, Phd, Oregon Social Learning Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Price, J., Chamberlain, P., Landsverk, J., & Reid, J. B. (2010). KEEP foster parent training intervention: Model description and effectiveness. Child and Family Social Work, 14, 233-242.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2006
Primær færdiggørelse (Faktiske)
1. oktober 2013
Studieafslutning (Faktiske)
1. oktober 2013
Datoer for studieregistrering
Først indsendt
6. marts 2012
Først indsendt, der opfyldte QC-kriterier
8. marts 2012
Først opslået (Skøn)
9. marts 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
8. april 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. april 2014
Sidst verificeret
1. april 2014
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- KEEP2020172
- R01DA020172 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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