- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT03142009
Gezinsluisterprogramma: implementatie en evaluatie bij meerdere stammen
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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New Mexico
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Jemez Pueblo, New Mexico, Verenigde Staten, 87024
- Pueblo of Jemez Department of Education
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Mescalero, New Mexico, Verenigde Staten, 88340
- Mescalero Prevention Program
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Pinehill, New Mexico, Verenigde Staten, 87357
- Ramah Navajo School Board
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Beschrijving
Inclusiecriteria: Inclusiecriteria omvatten alle families uit Mescalero Apache, Jemez Pueblo en Ramah Navajo met een kind van de vierde en vijfde klas en hun ouders of voogd, en grootouders die vrijwillig willen deelnemen.
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Uitsluitingscriteria: Degenen die niet in aanmerking komen voor dit onderzoek zijn: degenen die geen toestemming geven en/of instemmen met deelname; degenen die zich niet identificeren als stamleden van Mescalero Apache, Jemez Pueblo en Ramah Navajo of als het familielid van iemand die zich identificeert als Mescalero Apache, Jemez Pueblo en Ramah Navajo; kinderen en die niet in het beoogde bereik van het vierde en vijfde leerjaar vallen.
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Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Programma groep
Leden van het Tribal Research Team werven deelnemers door brieven naar huis te sturen met de kinderen van de vierde en vijfde klas.
Deze brief geeft een overzicht van het FL/CP en nodigt geïnteresseerde ouders en kinderen uit voor meer informatie.
TRT- en UNM-teamleden volgen individueel de geïnteresseerde ouders op.
Als families vastbesloten zijn om deel uit te maken van FL/CP, wordt er een bijeenkomst gepland om het geïnformeerde toestemmingsproces uit te voeren en de pretest te voltooien.
Gezinnen in de programmagroep wonen dan FL/CP-sessies bij die het intergenerationele cultureel aangepaste curriculum omvatten.
Programmagezinnen nemen ook deel aan verschillende aspecten van het programma, waaronder het voltooien van een communautair actieproject.
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Elke sessie begint met een collectief diner waarbij families samen eten.
Oefen dan hun Indiase en clannamen.
De sessies worden geleid door facilitators in hun eigen taal of tweetalig.
De begeleiders verdelen de gezinnen vervolgens in groepen kinderen en volwassenen om het thema van de sessie te behandelen, en aan het einde van de sessie komen ze samen terug om hun lessen te delen.
De sessies eindigen altijd met de kinderen en volwassenen die in hun dagboeken schrijven, dit zijn afzonderlijke pagina's die ze vervolgens in hun curriculummappen stoppen.
Gezinnen krijgen dan hun 'thuisoefening', een taak die de gezinnen in de tussenliggende week samen doen.
De facilitators verzamelen de leermap na elke sessie om de volgende week mee te nemen naar de gezinnen.
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Geen tussenkomst: Vergelijkingsgroep
Na ontvangst van de brief zullen gezinnen die ervoor hebben gekozen niet deel te nemen of die weigeren deel te nemen, worden uitgenodigd om deel te nemen aan het onderzoek als vergelijkingsdeelnemers.
Vergelijkende deelnemers wonen de FL/CP-sessies niet bij en doen alleen de pre-, post- en 1 year post-tests.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Welzijn van kinderen
Tijdsspanne: Post-test (2-4 maanden na interventie)
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Zelfrapportagemaatregelen van angst, angstpaniek/GAD-subschaal, gemiddelde verandering ten opzichte van de basislijn (participatie pre-program).
Angstartikelen worden gecodeerd 1-4 gecodeerd.
De schaal werd berekend als het rekenkundige gemiddelde van items, wat resulteert in een minimale waarde van 1 en een maximale waarde van 4. Lagere scores zijn beter.
De subschaal van paniek/GAD was het gemiddelde van drie items met dezelfde min/max als de volledige schaal.
Kinderen onderzocht op pre-test, post-test (2-4 maanden na interventie) en een jaar na interventie.
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Post-test (2-4 maanden na interventie)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Welzijn van kinderen
Tijdsspanne: Post-Post Survey: een jaar na de interventie
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Zelfrapportagemaatregelen van depressie, verandering van de basislijn na een jaar, depressieschaalartikelen werden gecodeerd 1 tot 3 en het rekenkundig gemiddelde van 26 items werd gebruikt om de schaal te berekenen.
De schaal heeft minimaal 1,0 en een maximum van 3,0 met hogere waarden is beter, d.w.z. lagere niveaus van depressie.
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Post-Post Survey: een jaar na de interventie
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Lorenda Belone, PhD, University of New Mexico
- Hoofdonderzoeker: Nina Wallerstein, DrPH, University of New Mexico
Publicaties en nuttige links
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- 14-289
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