- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06821035
Den trives undersøgelse: Undervisning i sund regulering i enkeltpersoner og sårbare miljøer
Undervisning af unge og familier selvreguleringsevner for at forstyrre virkningen af ugunstige barndomsoplevelser: Forebyggelse af stofbrug i modgang- påvirket ungdom
Målet med denne 2-arm randomiserede kontrolforsøg er at bestemme virkningen af en samfunds sundhedsarbejder leverede coachingintervention, grus, på at forhindre den tidlige indledning af regelmæssig brug af alkohol og cannabis blandt modgang-impacted unge i alderen 11-14 år, der ikke gør Brug regelmæssigt alkohol eller cannabis ved baseline. De specifikke mål inkluderer:
- Mål 1. Undersøg effekten af korn på at forhindre den tidlige påbegyndelse af regelmæssig alkohol- og cannabisbrug over tid.
- Mål 2.. Undersøg rollen som ungdom og plejerens selvregulering i formidlingen af virkningen af korn på ungdomsfrekvenser for brug af alkohol og cannabis.
Forskere vil sammenligne deltagere, der er randomiseret til grusinterventionen med en aktiv kontrolgruppe, der modtager et digitalt statsborgerskabsplan for at se, om de, der deltager i Grit, oplever større forbedringer i selvregulering og lavere kardiometaboliske risici.
Deltagerne vil:
- Blive randomiseret til enten at modtage grusinterventionen (eksperimentel gruppe) eller det digitale statsborgerskabsplan (Active Control Group)
- Komplet 3 personlige besøg ved baseline, post-intervention og 12-måneders postintervention
- Komplette HRV-vurderinger ved hjælp af Emwave Pro Plus og undersøgelsesvurderinger på REDCAP under personlige besøg.
- Deltag i seks 60-minutters sessioner gennemført over 8 uger via Zoom med en tildelt arbejdstager i samfundet
- Blive inviteret til at gennemføre en booster-session på 6 måneder efter intervention
- Komplette online foranstaltninger ved baseline, post-intervention, 6-måneders og 12-måneders post-intervention
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Dawn T. Bounds, Ph.D.
- Telefonnummer: 949-742-7109
- E-mail: boundsd@hs.uci.edu
Undersøgelse Kontakt Backup
- Navn: Jenny Fotang
- Telefonnummer: 949-516-1694
- E-mail: jfotang@hs.uci.edu
Studiesteder
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California
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Irvine, California, Forenede Stater, 92697-7600
- Rekruttering
- The Regents of the University of California, Irvine
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Kontakt:
- Madison Spiva
- Telefonnummer: 9498247688
- E-mail: mspiva@uci.edu
-
Ledende efterforsker:
- Dawn T. Bounds, Ph.D.
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Beskrivelse
Inkluderingskriterier:
- Ungdom i alderen 11-14 år, der scorer i kategorien højrisiko (dvs. 4 eller flere esser) på ACES- og giftig stressrisikovurderingsalgoritme
- Har adgang til en smartphone og er villig til at downloade relevante apps (95% af alle unge har adgang til en smartphone)
- Ungdom, der er i stand til at tale og læse på engelsk
- Har en forælder/værge/primær plejeperson (18 år eller ældre), der er engelsk- eller spansktalende og villig til at deltage i interventionen.
Ekskluderingskriterier:
- Ungdom, der ikke kan tale og læse på engelsk
- Ungdom, der rapporterer enhver alkohol eller cannabisbrug inden for de sidste 14 dage
- Ungdom, der i øjeblikket er indskrevet i en anden familiebaseret intervention (dvs. familieterapi)
- Ungdom i akut nød, der har øjeblikkelig behov for pleje (f.eks. Overhængende risiko for skade på mig selv eller andre, aktiv psykose)
- Ungdom, der rapporterer om deres plejers hjemmemiljø, er utrygt at vende tilbage til, er blevet betragtet som usikker eller kræver overvåget besøg af Department of Children and Family Services (DCFS)
- Ungdom, hvis forælder/værge/primær plejer afviser deltagelse, vil blive henvist til andre programmer i deres samfund.
- På grund af at medikamenteksperimentering er almindelig i ungdomsårene, vores interesse i at forhindre den tidlige påbegyndelse af regelmæssig brug af alkohol- og cannabisbrug og unge, der regelmæssigt bruger stoffer, der kræver en anden indgriben, tilmelder vi unge, der oprindeligt rapporterer den nylige cannabisbrug, men senere rapporterer nr Brug inden for de sidste to uger og har en bekræftende negativ urinlægemiddel screening.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Grit Intervention
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Dyader, der tilfældigt er tildelt til at indsamle modstandsdygtighed i traumatiseret ungdom og familier (Grit), vil modtage en samfunds sundhedsarbejder leveret psykoeducational intervention, der inkluderer 6 ugentlige sessioner, der er fokuseret på: 1) Supportive Health Coaching for at få modstandsdygtighed via psykoeducation og fremme af bufferingsbeskyttelsesfaktorer i begge Ungdom og plejere og 2) letter selvregulering ved hjælp af hjerterytme (HRV) biofeedback.
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Aktiv komparator: Digital statsborgerskabsplan
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Dyads tilfældigt tildelt DCC vil modtage en sundhedsarbejder, der er leveret, skoleklasse-specifik indgriben, der inkluderer 6 ugentlige sessioner, der fokuserer på at hjælpe unge med at navigere i kompleksiteten ved at leve i en digital verden.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Alkohol, cannabis og anden stofbrug: CDC Youth Risk Behaviour Surveillance System (YRBSS)+ tidslinje efterfølgende metodevurdering (TFB)
Tidsramme: Baseline, umiddelbart efter interventionen, 6 måneder efter intervention, 12 måneder efter intervention
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YRBSS er en multiple-choice-undersøgelse, der indsamler sundhedsadfærdshistorik, herunder spørgsmål om alkohol- og cannabisbrug.
Ungdom, der rapporterer enhver stofbrug i de sidste 30 dage på YRB'erne, afslutter tidslinjen efterfølgende metodevurdering (TFB) i de sidste 30 dage.
TFB bruges til at vurdere nylige marihuana, cigaret, alkohol og anden stofbrug.
Den selvadministrerede TFB på 14 punkter beder respondenterne om retrospektivt at estimere deres daglige lægemiddel over et bestemt tidsrum fra 7 dage til 2 år før administrationsdatoen.
TFB kan bruges til at opnå en række kvantitative estimater af stofbrug, herunder ændring i stofbrug.
Forudsigelig gyldighed, overensstemmelse af TFB med andre mål for stofbrug og stærk konvergens blandt TFB, urinassays, selvrapportering og sikkerhedsforælder og søskende rapporter er blevet påvist blandt hvide og minoritiserede unge.
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Baseline, umiddelbart efter interventionen, 6 måneder efter intervention, 12 måneder efter intervention
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Følelsesmæssig regulering: vanskeligheder i følelsesmæssig regulering- kort form (DERS-SF)
Tidsramme: Baseline, umiddelbart efter interventionen, 6 måneder efter intervention, 12 måneder efter intervention
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DERS-SF er en 18-punkts forkortet version af den originale 36-punkts DERS-spørgeskema.
Den måler følelsesreguleringsevne baseret på 6 underskalaer: strategier, ikke-accept, impuls, mål, opmærksomhed og klarhed.
Alle underskalaer på DERS -SF er meget korreleret med de originale DERS med korrelationer, der spænder fra .91 -.98.
Hver af DERS-SF-underskalaerne har en Cronbach α> .70
(lige fra 0,79 til 0,91).
De samlede scoringer varierer fra 18 til 90, med højere total score på DERS-SF, hvilket indikerer større vanskeligheder med følelsesregulering.
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Baseline, umiddelbart efter interventionen, 6 måneder efter intervention, 12 måneder efter intervention
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Vurdering af hjerterytmevariabilitet: Emwave Pro
Tidsramme: Baseline, umiddelbart efter interventionen, 12 måneder efter intervention
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Emwave Pro er et hjerterytmeovervågningssystem, der hjælper med at observere den enkeltes autonome tilstand.
Denne software leverer HRV -vurderinger, der kan bruges i en lang række applikationer, såsom kvantificering af HRV -niveauer.
Ved hjælp af Heartmaths Emwave Pro-software vil enhver deltager have en HRV-vurdering udført, der inkluderer en hvilende HRV-vurdering (3 minutter), en stressforberedelse (3 minutter) og en 1-minutters dyb vejrtrækningsvurdering.
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Baseline, umiddelbart efter interventionen, 12 måneder efter intervention
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Søvnkvalitet: Pittsburgh Sleep Quality Index (PSQI)
Tidsramme: Baseline, umiddelbart efter interventionen, 6 måneder efter intervention, 12 måneder efter intervention
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PSQI er et spørgeskema på 19 punkter, der vurderer syv komponentresultater; Subjektiv søvnkvalitet, søvnlatens, søvnvarighed, sædvanlig søvneffektivitet, søvnforstyrrelser, brug af søvnmedicin og dysfunktion på dagen.
PSQI har en intern pålidelighed på 0,83 og test-retest-pålidelighed på 0,85 i verdensplan.
PSQI globale scoringer spænder fra 0 til 21, med højere score end 5, der indikerer søvnforstyrrelse.
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Baseline, umiddelbart efter interventionen, 6 måneder efter intervention, 12 måneder efter intervention
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Ernæring: CDC Youth Risk Behaviour Surveillance System (YRBSS)
Tidsramme: Baseline, umiddelbart efter interventionen, 6 måneder efter intervention, 12 måneder efter intervention
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Middle School-versionen 2025 af YRBSS er en national undersøgelse, der inkluderer 3 diæt og vægtrelaterede genstande, der vurderer ernæring, der muliggør national sammenligning med andre unge.
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Baseline, umiddelbart efter interventionen, 6 måneder efter intervention, 12 måneder efter intervention
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Fysisk aktivitet: CDC Youth Risk Behaviour Surveillance System (YRBSS)
Tidsramme: Baseline, umiddelbart efter interventionen, 6 måneder efter intervention, 12 måneder efter intervention
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Middle School -versionen 2025 af YRBSS er en national undersøgelse, der inkluderer 3 poster, der vurderer fysisk aktivitet, der tillader national sammenligning med andre unge.
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Baseline, umiddelbart efter interventionen, 6 måneder efter intervention, 12 måneder efter intervention
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Familiefunktion: Familievurderingsenhed (FAD)
Tidsramme: Baseline, umiddelbart efter interventionen, 6 måneder efter intervention, 12 måneder efter intervention
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FAD er en 60-punkts undersøgelse, der vurderer familiefunktion, herunder problemløsning, kommunikation, roller, affektive lydhørhed, affektive involvering og adfærdskontrol.
Resultater spænder fra 1 til 4 for hvert svar.
Jo højere den samlede score, jo værre er niveauet for familiefunktion.
Det har pålidelighed på 0,70 for alle underskalaer undtagen roller.
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Baseline, umiddelbart efter interventionen, 6 måneder efter intervention, 12 måneder efter intervention
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Psykologisk fleksibilitet:
Tidsramme: Baseline, umiddelbart efter interventionen, 6 måneder efter intervention, 12 måneder efter intervention
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Accept- og fusionsspørgeskemaet (AFQ_Y8): Et 8-punkts spørgeskema udviklet til ungdom, der undersøger deres psykologiske ufleksibilitet.
Det har en intern konsistens på .83.
Mulige samlede scoringer spænder fra 0 til 32.
En højere total score indikerer større tendens til at opleve kognitiv fusion (dvs.
lavere psykologisk fleksibilitet).
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Baseline, umiddelbart efter interventionen, 6 måneder efter intervention, 12 måneder efter intervention
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Psykologisk fleksibilitet:
Tidsramme: Baseline, umiddelbart efter interventionen, 6 måneder efter intervention, 12 måneder efter intervention
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Accept- og handlingsspørgeskemaet (AAQ-II): Et spørgeskema på 7 punkter udviklet til voksne til at måle deres psykologiske ufleksibilitet og eksperimentel undgåelse.
Det har en intern konsistens på .84 og test-retest-pålidelighed på .79-
.81.
Mulige samlede scoringer spænder fra 7 til 49.
Højere samlede score på AAQ-II indikerer højere psykologisk ufleksibilitet, oplevelsesmæssig undgåelse og mere potentiel psykologisk nød.
Lavere samlede score betyder mere psykologisk fleksibilitet.
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Baseline, umiddelbart efter interventionen, 6 måneder efter intervention, 12 måneder efter intervention
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Psykologisk stress: Opfattet stressskala (PSS-10)
Tidsramme: Baseline, umiddelbart efter interventionen, 6 måneder efter intervention, 12 måneder efter intervention
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PSS-10 er en 10-vars selvmåling af psykologisk stress.
Det har to underskalaer: opfattet hjælpeløshed og mangel på selveffektivitet.
Det har en Cronbachs alfa> .70 og en test-retest-pålidelighed på> .70.
De samlede scoringer spænder fra 0 til 40, hvor højere score er tegn på højere niveauer af opfattet stress.
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Baseline, umiddelbart efter interventionen, 6 måneder efter intervention, 12 måneder efter intervention
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Dawn T. Bounds, Ph.D., University of California, Irvine
- Studieleder: Norweeta G. Milburn, Ph.D., University of California, Los Angeles
- Studieleder: Karnik Niranjan, M.D., Ph.D., University of California, Los Angeles
- Studieleder: Shin Sanghyuk, Ph.D., University of California, Irvine
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- 4821
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