- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02684903
Studie naar alternatieve opvoedingsstrategieën (CAPS). (CAPS)
Coaching Alternative Parenting Strategies (CAPS) Studie: gericht op neurobiologische en gedragsmechanismen van zelfregulatie in gezinnen met een hoog risico
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Kindermishandeling (CM) vormt een ernstig probleem voor de volksgezondheid in de Verenigde Staten en het is bekend dat het de ontwikkeling van zelfregulerende vaardigheden van kinderen in gevaar brengt en het risico op middelengebruik en andere regelstoornissen vergroot. Parent-Child Interaction Therapy (PCIT), een intensieve ouderschapsinterventie van 20 sessies, heeft aangetoond dat het de kwaliteit van CM-opvoeding verbetert, positief ouderschap en kindgedrag verbetert en leidt tot afname van CM-recidive (Chaffin et al., 2004) hoewel de mechanismen die ten grondslag liggen aan de effecten ervan weinig worden begrepen. Dit project pakt lacunes in de CM-interventieliteratuur aan doordat het (a) een experimenteel interventieontwerp gebruikt om een theoretisch model van verandering te testen dat ten grondslag ligt aan de effecten van PCIT, (b) een reeks neurogedragsmetingen van zelfregulatie omvat, en (c) gebruik maakt van observatiemetingen van ouderschap in een RCT van een evidence-based interventie voor het versterken van de zelfregulatie van ouders, het verminderen van CM en het ondersteunen van verbeteringen in de regulatie en het gedrag van het kind. Studiedoelen zijn:
Doel 1: Test de belangrijkste effecten van PCIT op CM-specifieke resultaten, inclusief vermindering van hard, aversief ouderschap en CM-recidive en bevordering van gedragsaanpassing van kinderen. Er wordt verondersteld dat interventiegezinnen significant grotere gedragsverbeteringen zullen vertonen (d.w.z. minder negatief ouderschap, meer positief ouderschap en minder internaliserende/externaliserende problemen van het kind) bij de posttest en minder CM-recidive na 6 maanden follow-up, in vergelijking met gezinnen die hulp krijgen zoals gewoonlijk (SAU).
Specifiek doel 2: Bepaal de impact van PCIT op indices van zelfregulatie van CM-ouders. Eerst zullen de onderzoekers de hypothese testen dat PCIT directe effecten uitoefent op het verbeteren van de capaciteiten van CM-ouders voor zelfregulatie in de context van opvoeding. Ten tweede zullen de onderzoekers onderzoeken hoe maatregelen van zelfregulatie bij ouders PCIT-interventie-effecten mediëren op vermindering van CM en verbeteringen in ouderschap. Ten derde zullen de onderzoekers onderzoeken of de zelfreguleringsniveaus van ouders vóór de interventie de interventie-effecten op de uitkomsten matigen. De modererende rol van CM-subtype (d.w.z. fysieke mishandeling versus verwaarlozing), ernst en andere belangrijke sociaal-contextuele factoren op de uitkomsten van interesse zullen ook worden overwogen.
Specifiek doel 3: Onderzoek naar de impact van PCIT op neurologische gedragsindices van de zelfregulatie van CM-kinderen. CM oefent nadelige effecten uit op het zich ontwikkelende vermogen van kinderen om aandacht, emotie, fysiologie en gedrag te reguleren. Tekorten in deze domeinen geven een verhoogd risico op psychopathologie, vroege gedragsproblemen en later middelenmisbruik. De onderzoekers veronderstellen dat PCIT, hoewel primair gericht op ouderschap, verbeteringen zal bewerkstelligen in neurobiologische indicatoren van de zelfregulatie van CM-kinderen na de behandeling, ten opzichte van de controlegroep. Vervolgens zullen de onderzoekers testen in hoeverre de uitkomsten van het kind worden gemedieerd door interventie-effecten op het ouderschap. Er wordt verondersteld dat reguleringstekorten en gedragsproblemen van kinderen zullen worden verzacht door op PCIT gebaseerde verminderingen van aversief ouderschap die het gevolg zijn van de interventie.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Oregon
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Eugene, Oregon, Verenigde Staten, 97403
- University of Oregon
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Beschrijving
Inclusiecriteria:
- Inwoner van Lane County
- Ouder is 18 jaar of ouder
- Biologische of verzorgende moeder van een kind tussen 3 en 7 jaar bij aanvang
- Woont in dezelfde thuissituatie als het kind
- Moet vloeiend Engels spreken
- Moeder en kind moeten fysiek in staat zijn om de beoordeling te voltooien
- Familie heeft een open zaak met Lane County Dept. Gezondheidszorg.
Uitsluitingscriteria:
- Seksueel misbruik van kinderen in het gezin
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Ouder-kind interactietherapie (PCIT)
Deelnemers krijgen Parent Child Interaction Therapy (PCIT). PCIT is ontworpen om het functioneren van het kind te verbeteren door patronen van harde, dwingende interactie te onderbreken en het warme, positieve ouderschap, de autonomie-ondersteuning en competente managementvaardigheden van ouders te verbeteren. . |
PCIT is een 16-20 sessies live-coaching opvoedinterventie.
PCIT voor gezinnen met kinderwelzijn wordt geleverd in twee opeenvolgende behandelfasen na een training ter verbetering van de motivatie: fase 1, op kinderen gerichte interactie (CDI) om positief ouderschap te versterken en hard aversief ouderschap te onderbreken, en fase 2, op ouders gerichte interactie (PDI) om coach effectieve oudercommando's en een consistent time-outprotocol wanneer het kind ongehoorzaam is.
Andere namen:
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Geen tussenkomst: Diensten zoals gebruikelijk (SAU)
Deelnemers ontvangen alle gebruikelijke diensten van het Department of Human Services (DHS) Children's Services.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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DPICS-IV Geobserveerde ouderschapsvaardigheden (tijdens door kinderen geleid spel)
Tijdsspanne: Pre- en post-interventie (8 maanden)
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Het Dyadic Parent-Child Interaction Coding System (DPICS) codeerde positieve "TROTS"-opvoedingsvaardigheden en negatief "Niet-vaardigheden"-opvoedingsgedrag tijdens de DPICS Child-Led Play-taak.
Scores weerspiegelen gedragstellingen tijdens de taak van 5 minuten, waarbij hogere scores meer gedrag weerspiegelen.
Hogere positieve ouderschapsscores weerspiegelen betere resultaten, terwijl hogere negatieve ouderschapsscores slechtere resultaten weerspiegelen.
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Pre- en post-interventie (8 maanden)
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DPICS-IV Observationele codering tijdens opruimsituatietaak
Tijdsspanne: Pre- en post-interventie (8 maanden)
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DPICS-gecodeerde positieve "TROTS"-opvoedingsvaardigheden, effectieve ouderopdrachten en nalevingsgedrag van kinderen tijdens de DPICS-opruimsituatietaak.
Positieve ouderschapsscores weerspiegelen het percentage van het totale gecodeerde gedrag tijdens de taak dat positieve 'TROTS'-vaardigheden betreft.
Effectieve (directe) ouderopdrachten weerspiegelen het percentage van alle opdrachten die directe, compatibele opdrachten waren.
De nalevingsscores van kinderen weerspiegelden het percentage effectieve, directe bevelen dat het kind opvolgde in de onmiddellijk volgende gedragsverandering.
Hoge scores op alle drie de schalen weerspiegelen betere resultaten.
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Pre- en post-interventie (8 maanden)
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Stopsignaaltaak: verhoogde ouderremmende controle
Tijdsspanne: pre- en post-interventie (8 maanden)
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De Stop Signal Response Time (SSRT) werd gebruikt om de efficiëntie van het oorspronkelijke remmende controleproces of de tijd in milliseconden die nodig is om een remmende reactie op gang te brengen, te beoordelen.
Lagere SSRT-scores weerspiegelen snellere reactietijden en betere remmende controle.
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pre- en post-interventie (8 maanden)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Verminderde recidive van kindermishandeling
Tijdsspanne: tot 1 jaar na de behandeling
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Minder nieuwe episoden van CM per Mishandelingsclassificatie Codering van dossiers van kinderwelzijnszaken
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tot 1 jaar na de behandeling
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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KORTE-A: Schaal voor emotionele controle (verhoogde emotieregulatie van ouders)
Tijdsspanne: pre- en post-interventie (8 maanden)
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Ouders rapporteren zelf op de BRIEF-A Emotionele Controle-probleemschaal, waarbij lagere scores wijzen op minder problemen met emotiebeheersing (dat wil zeggen, betere emotieregulatie).
Er worden gestandaardiseerde T-scores (M=50, SD = 10) verkregen.
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pre- en post-interventie (8 maanden)
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KORT (Gedragsbeoordelingsinventaris van de uitvoerende functie) Resultaten van kinderen
Tijdsspanne: voor en na de interventie
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KORTE scores van kinderen per ouderrapportage op de schalen van problemen met remmen, verschuiven en emotionele controle, waarbij lagere scores minder problemen met de regelgeving weerspiegelen.
Er worden gestandaardiseerde T-scores (M=50, SD = 10) verkregen.
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voor en na de interventie
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Fysiologische regulatie van ouders
Tijdsspanne: voor en na de interventie
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fysiologische regulatie (Respiratoire Sinus Aritmie of RSA-scores zijn een perifere fysiologische marker van emotieregulatie die de hartactiviteit van het parasympathische zenuwstelsel van de ouders weerspiegelt.
RSA-scores werden verkregen van ouders in rust en als reactie op emotioneel opvallende interacties met hun kind.
Hogere RSA-scores weerspiegelen een grotere parasympathische hartregulatie (beter resultaat).
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voor en na de interventie
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Emotieregulatie van kinderen
Tijdsspanne: Postinterventie (6 maanden)
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Emotionele go/no-go taakuitvoering: valse alarmen tot woede.
Hogere scores weerspiegelen een groter aantal valse alarmen tot woede (slechter resultaat).
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Postinterventie (6 maanden)
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Kinderfysiologische regulatie
Tijdsspanne: pre- en post-interventie (8 maanden)
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fysiologische regulatie (Respiratoire Sinus Aritmie of RSA-scores zijn een perifere fysiologische marker van emotieregulatie die de hartactiviteit van het parasympathische zenuwstelsel van kinderen weerspiegelt.
RSA-scores werden verkregen van kinderen in rust en als reactie op emotioneel opvallende interacties met hun ouders.
Hogere RSA-scores weerspiegelen een grotere parasympathische hartregulatie (beter resultaat).
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pre- en post-interventie (8 maanden)
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Verminderde kindersymptomen
Tijdsspanne: pre- en post-interventie (8 maanden)
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Scores op de traumasymptoomchecklist (TSCL-YC); Er worden T-scores gerapporteerd, waarbij 50 het populatiegemiddelde aangeeft met een standaarddeviatie van 10; hogere scores duiden op grotere traumasymptomen.
Klinisch significante verhogingen op de TSCL-YC worden weerspiegeld door scores op of boven de grenswaarde T=70
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pre- en post-interventie (8 maanden)
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Eyberg Child Behavior Inventory (ECBI) Probleemscores voor kindergedrag (verminderde disruptieve gedragsproblemen)
Tijdsspanne: pre- en post-interventie (8 maanden)
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De ECBI bestaat uit de door ouders gerapporteerde intensiteit van probleemgedrag van kinderen (ECBI-Intensiteitsscore) en het aantal problematische gedragingen van kinderen (EBCI-Probleemscore).
Er worden gestandaardiseerde T-scores (M=50, SD=10) gerapporteerd, waarbij lagere scores een succesvoller resultaat weerspiegelen.
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pre- en post-interventie (8 maanden)
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KORTE-A: Zelfbeoordelingen van ouders
Tijdsspanne: pre- en post-interventie (8 maanden)
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Ouders rapporteren zelf over de BRIEF-A, waarbij lagere scores een weerspiegeling zijn van minder problemen met de controle op de regelgeving.
Er worden gestandaardiseerde T-scores (M=50, SD = 10) verkregen.
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pre- en post-interventie (8 maanden)
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Elizabeth A Skowron, PhD, University of Oregon
Publicaties en nuttige links
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