Coaching alternative forældrestrategier (CAPS) undersøgelse (CAPS)
12. oktober 2023 opdateret af: Elizabeth Skowron, University of Oregon
Coaching Alternative Parenting Strategies (CAPS) undersøgelse: Målretning af neurobiologiske og adfærdsmæssige mekanismer for selvregulering i højrisikofamilier
Dette er et randomiseret, kontrolleret forsøg med Parent-Child Interaction Therapy (PCIT) designet til at teste virkningerne af PCIT på selvregulering og adfærd hos børn, der mishandler (CM) forældre og deres folkeskolebørn.
To hundrede og halvtreds (250) mishandlende mødre og deres børn (alder 5-8 år) vil blive trukket fra Child Protective Services og randomiseret til PCIT-interventionen eller en kontroltilstand (services as usual).
Nøgle kontekstuelle risikofaktorer vil blive vurderet, herunder kumulativ risiko, forældres mentale sundhed og forældres stofbrug.
En multirater, multimetode tilgang til vurdering vil omfatte målinger af selvregulering, forældreevner og børns adfærdsresultater.
Familier vil blive fulgt til 1 år for CM recidiv.
Resultater fra denne foreslåede undersøgelse forventes at have betydelige implikationer for optimering af CM forældreinterventioner ved (a) at bestemme følsomheden af CM forældres og børns neuroadfærdsmæssige selvreguleringssystemer over for intervention og (b) identificere individuelle forskelle i selvregulering, der medierer og moderat respons på intervention og langsigtet fastholdelse af gevinster.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Børnemishandling (CM) udgør et alvorligt folkesundhedsproblem i USA og er kendt for at kompromittere børns udviklende selvreguleringsevner og forstærke risikoen for stofbrug og andre regulatoriske forstyrrelser. Parent-Child Interaction Therapy (PCIT), en intensiv, 20-sessions forældreintervention, har vist sig at forbedre kvaliteten af CM-forældreopdragelse, forbedre positivt forældreskab og børns adfærd og producere fald i CM-recidivisme (Chaffin et al., 2004) selvom de mekanismer, der ligger til grund for dets virkninger, er lidt forståede. Dette projekt adresserer huller i CM-interventionslitteraturen ved, at det (a) bruger et eksperimentelt interventionsdesign til at teste en teoretisk model for forandring, der ligger til grund for PCIT's virkninger, (b) inkluderer et batteri af neuroadfærdsmæssige mål for selvregulering og (c) anvendelser observationsmålinger af forældreskab i en RCT af en evidensbaseret intervention til styrkelse af forældres selvregulering, reduktion af CM og understøttelse af forbedringer i børns regulering og adfærd. Studiets mål er at:
Mål 1: Test de vigtigste virkninger af PCIT på CM-specifikke resultater, herunder reduktioner i hårdt, afersivt forældreskab og CM-recidiv og fremme af børns adfærdstilpasning. Det antages, at interventionsfamilier vil vise signifikant større adfærdsforbedringer (dvs. reduceret negativt forældreskab, øget positivt forældreskab og reduceret børns internaliserings-/eksternaliseringsproblemer) ved posttest og lavere CM-recidiv ved 6-måneders opfølgning sammenlignet med familier, der modtager tjenester som sædvanlig (SAU).
Specifikt mål 2: Bestem virkningen af PCIT på indekser for CM-forældres selvregulering. For det første vil efterforskerne teste hypotesen om, at PCIT udøver direkte effekter på at forbedre CM-forældres kapacitet til selvregulering i forbindelse med forældreskab. For det andet vil efterforskerne undersøge, hvordan mål for selvregulering hos forældre medierer PCIT-interventionseffekter på reduktion af CM og forbedringer i forældreskab. For det tredje vil efterforskerne undersøge, om forældres præinterventions selvreguleringsniveauer modererer interventionseffekter på resultater. De modererende roller af CM-subtype (dvs. fysisk misbrug vs. omsorgssvigt), sværhedsgrad og andre vigtige sociokontekstuelle faktorer på resultaterne af interesse vil også blive overvejet.
Specifikt mål 3: Undersøg virkningen af PCIT på neuroadfærdsindekser for CM børns selvregulering. CM udøver en skadelig virkning på børns udviklingsevne til at regulere opmærksomhed, følelser, fysiologi og adfærd. Underskud på disse områder giver øget risiko for psykopatologi, tidligt opståede adfærdsproblemer og senere stofmisbrug. Efterforskerne antager, at PCIT, selvom det primært er rettet mod forældreskab, vil bevirke forbedringer i neurobiologiske indikatorer for CM-børns selvregulering efter behandling, i forhold til kontrolgruppen. Dernæst vil efterforskerne teste, i hvilket omfang børns resultater medieres gennem interventionseffekter på forældreskabet. Det er en hypotese, at børns reguleringsmangler og adfærdsproblemer vil blive svækket af PCIT-baserede reduktioner i aversivt forældreskab som følge af interventionen.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
408
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Oregon
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Eugene, Oregon, Forenede Stater, 97403
- University of Oregon
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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
3 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Indbygger i Lane County
- Forælder er 18 år eller ældre
- Biologisk mor eller forældremyndighedsindehaver til et barn mellem 3 og 7 år ved baseline
- Bor i samme hjemmemiljø med barnet
- Skal være flydende i engelsk
- Mor og barn skal være fysisk i stand til at gennemføre vurderingen
- Familien har en åben sag med Lane County Dept. Sundhedsydelser.
Ekskluderingskriterier:
- Seksuelt misbrug af børn i familien
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Parent Child Interaction Therapy (PCIT)
Deltagerne modtager Parent Child Interaction Therapy (PCIT). PCIT er designet til at forbedre børns funktion ved at afbryde mønstre af barsk, tvangsinteraktion og forbedre forældres varme, positive forældreskab, autonomistøtte og kompetente børneledelsesevner. . |
PCIT er en 16-20 sessioner live-coachende forældreintervention.
PCIT til børneværnsfamilier leveres i to sekventielle behandlingsfaser efter en motivationsforstærkende træning: Fase 1, Child-Directed Interaction (CDI) for at forbedre positivt forældreskab og afbryde barsk afersivt forældreskab, og fase 2, Parent-Directed Interaction (PDI) til træner effektive forældrekommandoer og en konsekvent time-out-protokol, når barnet ikke adlyder.
Andre navne:
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Ingen indgriben: Services As Usual (SAU)
Deltagerne modtager alle de sædvanlige tjenester, der leveres af Department of Human Services (DHS) Children's Services.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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DPICS-IV Observerede forældrefærdigheder (under børnestyret leg)
Tidsramme: Før og efter indgreb (8 måneder)
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Dyadic Parent-Child Interaction Coding System (DPICS) kodede positive "PRIDE" forældrefærdigheder og negative "Don't skills" forældreadfærd under DPICS Child-Led Play opgaven.
Scoringer afspejler adfærdsmæssige tæller under den 5-minutters opgave, hvor højere score afspejler mere adfærd.
Højere positive forældrescore afspejler bedre resultater, hvorimod højere negative forældreskabsscore afspejler dårligere resultater.
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Før og efter indgreb (8 måneder)
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DPICS-IV Observationskodning under oprydningssituationsopgave
Tidsramme: Før og efter indgreb (8 måneder)
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DPICS-kodede positive "PRIDE" forældrefærdigheder, effektive forældrekommandoer og børneoverholdelsesadfærd under DPICS-oprydningssituationen.
Positive forældrescore afspejler procentdelen af samlet kodet adfærd under opgaven, der er positive "PRIDE" færdigheder.
Effektive (direkte) overordnede kommandoer afspejler procentdelen af alle kommandoer, der var direkte, kompatible kommandoer.
Børns overholdelsesscore afspejlede procentdelen af effektive, direkte kommandoer, som barnet overholdt i den umiddelbart følgende adfærdsmæssige vending.
Høje scores på alle tre skalaer afspejler bedre resultater.
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Før og efter indgreb (8 måneder)
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Stopsignalopgave: Øget forældrehæmmende kontrol
Tidsramme: før og efter intervention (8 måneder)
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Stop Signal Response Time (SSRT) blev brugt til at vurdere effektiviteten af forældreinhiberende kontrolproces eller tid i millisekunder, der var nødvendig for at aktivere en inhiberende reaktion.
Lavere SSRT-score afspejler hurtigere reaktionstider og bedre hæmmende kontrol.
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før og efter intervention (8 måneder)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Reduceret børnemishandling (CM) recidiv
Tidsramme: op til 1 års efterbehandling
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Færre nye episoder af CM pr. mishandlingsklassifikation Kodning af sagsjournaler for børneværn
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op til 1 års efterbehandling
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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BRIEF-A: Følelsesmæssig kontrolskala (øget forældrefølelsesregulering)
Tidsramme: før og efter intervention (8 måneder)
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Forældre selvrapporterer på BRIEF- A Emotional Control-problemskalaen, hvor lavere score afspejler færre følelseskontrolproblemer (dvs. bedre følelsesregulering).
Standardiserede T-scores (M=50, SD = 10) opnås.
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før og efter intervention (8 måneder)
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BRIEF (Behavioural Rating Inventory of Executive Function) Børns resultater
Tidsramme: før og efter indgreb
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Børns BRIEF-score pr. forældre-rapport på skalaer for hæmning, skift og følelsesmæssig kontrol med problemer, hvor lavere score afspejler færre regulatoriske problemer.
Standardiserede T-scores (M=50, SD = 10) opnås.
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før og efter indgreb
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Forældres fysiologiske regulering
Tidsramme: før og efter indgreb
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fysiologisk regulering (respiratorisk sinusarytmi eller RSA-score, er en perifer fysiologisk markør for følelsesregulering, der afspejler forældres parasympatiske nervesystem-forbundne hjerteaktivitet.
RSA-score blev opnået fra forældre i hvile og som reaktion på følelsesmæssigt fremtrædende interaktioner med deres barn.
Højere RSA-score afspejler større parasympatisk hjerteregulering (bedre resultat).
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før og efter indgreb
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Regulering af børns følelser
Tidsramme: Efter intervention (6 mdr.)
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Følelsesmæssig go/no-go opgaveudførelse: Falske alarmer til vrede.
Højere score afspejler større frekvens af falske alarmer til vrede (værre udfald).
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Efter intervention (6 mdr.)
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Børnefysiologisk regulering
Tidsramme: før og efter intervention (8 måneder)
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fysiologisk regulering (respiratorisk sinusarytmi eller RSA-score, er en perifer fysiologisk markør for følelsesregulering, der afspejler børns parasympatiske nervesystem-forbundne hjerteaktivitet.
RSA-score blev opnået fra børn i hvile og som reaktion på følelsesmæssigt fremtrædende interaktioner med deres forælder.
Højere RSA-score afspejler større parasympatisk hjerteregulering (bedre resultat).
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før og efter intervention (8 måneder)
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Mindskede børns symptomer
Tidsramme: før og efter intervention (8 måneder)
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Traumesymptomchecklisteresultater (TSCL-YC); Der rapporteres T-score, hvor 50 angiver populationsgennemsnittet med en standardafvigelse på 10; højere score indikerer større traumesymptomer.
Klinisk signifikante forhøjelser på TSCL-YC afspejles af score ved eller over T=70 cutoff
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før og efter intervention (8 måneder)
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Eyberg Child Behavior Inventory (ECBI) Child Behavior Problem Scores (Reduceret forstyrrende adfærdsproblemer)
Tidsramme: før og efter intervention (8 måneder)
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ECBI består af forældrerapporteret intensitet af problematiske børns adfærd (ECBI-Intensity score) og antallet af problematiske børns adfærd (EBCI-Problem score).
Standardiserede T-scores (M=50, SD=10) rapporteres, med lavere score, der afspejler et mere vellykket resultat.
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før og efter intervention (8 måneder)
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BRIEF-A: Forældres selvvurderinger
Tidsramme: før og efter intervention (8 måneder)
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Forældre selv rapporterer om BRIEF-A med lavere score, der afspejler færre regulatoriske kontrolproblemer.
Standardiserede T-scores (M=50, SD = 10) opnås.
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før og efter intervention (8 måneder)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Elizabeth A Skowron, PhD, University of Oregon
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.
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Studiestart (Faktiske)
1. februar 2016
Primær færdiggørelse (Faktiske)
1. juni 2020
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1. april 2022
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Først indsendt
2. februar 2016
Først indsendt, der opfyldte QC-kriterier
17. februar 2016
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18. februar 2016
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2. november 2023
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. oktober 2023
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1. oktober 2023
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- 1R01DA036533-01A1 (U.S. NIH-bevilling/kontrakt)
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