Family Motivational Intervention in Schizophrenia (FMI)
21. juli 2010 oppdatert av: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Motivational Interviewing and Interaction Skills Training for Carers to Change Cannabis Use in Young Adults With Recent-onset Schizophrenia: Randomised Controlled Trial
Cannabis use by people with schizophrenia is associated with family distress and poor clinical outcomes. Therefore, an Family Motivational Intervention (FMI) was developed to help parents to motivate their child with a diagnoses of recent-onset schizophrenia to reduce cannabis use.
In a single-blind randomised clinical trail with 75 patients with the diagnosis of schizophrenia, parents will be assigned to either FMI or to routine care. Assessments will be conducted at baseline and at a 10- and 22-month follow-up. The study hypothesis is that FMI will be more effective than routine care in reducing (a) cannabis use in patients and (b) distress and sense of burden in parents.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
147
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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North Holland
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Amsterdam, North Holland, Nederland, 1066 DP
- Academic Medical Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
16 år til 40 år (Barn, Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Clinical diagnosis of schizophrenia or psychotic-related disorder
- Onset of schizophrenia or related disorder within pervious the 10 years
- Cannabis use at least 2 days per week in the 3 months prior to the assessment
- Antipsychotic medication in prescribed or indicated
- At least 10 hours of contact with the parents each week in the last month
Exclusion Criteria:
-
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Family Motivational Intervention
An intervention provided to parents consisting of 6 sessions of training in Interactions Skills and 6 sessions training in Motivational Interviewing.
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A intervention with provided parents 6 sessions of Interaction Skills training and 6 sessions Motivational Interviewing training.
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Aktiv komparator: Routine care for parents
Routine care for parents consisting of 2 sessions psycho-education and individual support
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A intervention with provided parents 6 sessions of Interaction Skills training and 6 sessions Motivational Interviewing training.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Cannabis use in patients with a diagnosis of recent-onset schizophrenia
Tidsramme: Baseline (before the start of the intervention)
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Baseline (before the start of the intervention)
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Cannabis use in patients with a diagnosis of recent-onset schizophrenia
Tidsramme: 10-month follow-up (3 months after the intervention has ended)
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10-month follow-up (3 months after the intervention has ended)
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Cannabis use in patients with a diagnosis of recent-onset schizophrenia
Tidsramme: 22-month follow-up (15 months after the intervention has ended)
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22-month follow-up (15 months after the intervention has ended)
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Medication adherence in patients with a diagnosis of recent-onset schizophrenia
Tidsramme: Baseline (before the start of the intervention)
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Baseline (before the start of the intervention)
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Medication adherence in patients with a diagnosis of recent-onset schizophrenia
Tidsramme: 10-month follow-up (3 months after the intervention has ended)
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10-month follow-up (3 months after the intervention has ended)
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Medication adherence in patients with a diagnosis of recent-onset schizophrenia
Tidsramme: 22-month follow-up (15 months after the intervention has ended)
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22-month follow-up (15 months after the intervention has ended)
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Quality of life in patients with recent-onset schizophrenia
Tidsramme: Baseline (before the start of the intervention)
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Baseline (before the start of the intervention)
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Quality of life in patients with recent-onset schizophrenia
Tidsramme: 10-month follow-up (3 months after the intervention has ended)
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10-month follow-up (3 months after the intervention has ended)
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Quality of life in patients with recent-onset schizophrenia
Tidsramme: 22-month follow-up (15 months after the intervention has ended)
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22-month follow-up (15 months after the intervention has ended)
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Stress in parents due to caring for a child with recent-onset schizophrenia
Tidsramme: Baseline (before the start of the intervention)
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Baseline (before the start of the intervention)
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Stress in parents due to caring for a child with recent-onset schizophrenia
Tidsramme: 10-month follow-up (3 months after the intervention has ended)
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10-month follow-up (3 months after the intervention has ended)
|
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Stress in parents due to caring for a child with recent-onset schizophrenia
Tidsramme: 22-month follow-up (15 months after the intervention has ended)
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22-month follow-up (15 months after the intervention has ended)
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Expressed emotion in parents of patients with recent-onset schizophrenia
Tidsramme: Baseline (before the start of the intervention)
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Baseline (before the start of the intervention)
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Expressed emotion in parents of patients with recent-onset schizophrenia
Tidsramme: 10-month follow-up (3 months after the intervention has ended)
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10-month follow-up (3 months after the intervention has ended)
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Expressed emotion in parents of patients with recent-onset schizophrenia
Tidsramme: 22-month follow-up (15 months after the intervention has ended)
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22-month follow-up (15 months after the intervention has ended)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studieleder: Gerard Schippers, Prof. dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Hovedetterforsker: Don Linszen, Prof.dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Studiestol: Lieuwe de Haan, Dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2006
Primær fullføring (Forventet)
1. august 2010
Studiet fullført (Forventet)
1. februar 2011
Datoer for studieregistrering
Først innsendt
20. juli 2010
Først innsendt som oppfylte QC-kriteriene
21. juli 2010
Først lagt ut (Anslag)
22. juli 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
22. juli 2010
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. juli 2010
Sist bekreftet
1. februar 2008
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Grant 100003014
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