Family Motivational Intervention in Schizophrenia (FMI)
21. juli 2010 opdateret af: 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.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
147
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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North Holland
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Amsterdam, North Holland, Holland, 1066 DP
- Academic Medical Center
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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
16 år til 40 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
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: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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)
|
|
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)
|
10-month follow-up (3 months after the intervention has ended)
|
|
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)
|
10-month follow-up (3 months after the intervention has ended)
|
|
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)
|
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)
|
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)
|
22-month follow-up (15 months after the intervention has ended)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studieleder: Gerard Schippers, Prof. dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Ledende efterforsker: 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)
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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2006
Primær færdiggørelse (Forventet)
1. august 2010
Studieafslutning (Forventet)
1. februar 2011
Datoer for studieregistrering
Først indsendt
20. juli 2010
Først indsendt, der opfyldte QC-kriterier
21. juli 2010
Først opslået (Skøn)
22. juli 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
22. juli 2010
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. juli 2010
Sidst verificeret
1. februar 2008
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Grant 100003014
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .