Family Motivational Intervention in Schizophrenia (FMI)
This study is enrolling participants by invitation only.
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Information provided by:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01167556
First received: July 20, 2010
Last updated: July 21, 2010
Last verified: February 2008
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cannabis Schizophrenia |
Behavioral: Family Motivational Intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Motivational Interviewing and Interaction Skills Training for Carers to Change Cannabis Use in Young Adults With Recent-onset Schizophrenia: Randomised Controlled Trial |
Resource links provided by NLM:
Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Primary Outcome Measures:
- Cannabis use in patients with a diagnosis of recent-onset schizophrenia [ Time Frame: Baseline (before the start of the intervention) ] [ Designated as safety issue: No ]
- Cannabis use in patients with a diagnosis of recent-onset schizophrenia [ Time Frame: 10-month follow-up (3 months after the intervention has ended) ] [ Designated as safety issue: No ]
- Cannabis use in patients with a diagnosis of recent-onset schizophrenia [ Time Frame: 22-month follow-up (15 months after the intervention has ended) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Medication adherence in patients with a diagnosis of recent-onset schizophrenia [ Time Frame: Baseline (before the start of the intervention) ] [ Designated as safety issue: No ]
- Medication adherence in patients with a diagnosis of recent-onset schizophrenia [ Time Frame: 10-month follow-up (3 months after the intervention has ended) ] [ Designated as safety issue: No ]
- Medication adherence in patients with a diagnosis of recent-onset schizophrenia [ Time Frame: 22-month follow-up (15 months after the intervention has ended) ] [ Designated as safety issue: No ]
- Quality of life in patients with recent-onset schizophrenia [ Time Frame: Baseline (before the start of the intervention) ] [ Designated as safety issue: No ]
- Quality of life in patients with recent-onset schizophrenia [ Time Frame: 10-month follow-up (3 months after the intervention has ended) ] [ Designated as safety issue: No ]
- Quality of life in patients with recent-onset schizophrenia [ Time Frame: 22-month follow-up (15 months after the intervention has ended) ] [ Designated as safety issue: No ]
- Stress in parents due to caring for a child with recent-onset schizophrenia [ Time Frame: Baseline (before the start of the intervention) ] [ Designated as safety issue: No ]
- Stress in parents due to caring for a child with recent-onset schizophrenia [ Time Frame: 10-month follow-up (3 months after the intervention has ended) ] [ Designated as safety issue: No ]
- Stress in parents due to caring for a child with recent-onset schizophrenia [ Time Frame: 22-month follow-up (15 months after the intervention has ended) ] [ Designated as safety issue: No ]
- Expressed emotion in parents of patients with recent-onset schizophrenia [ Time Frame: Baseline (before the start of the intervention) ] [ Designated as safety issue: No ]
- Expressed emotion in parents of patients with recent-onset schizophrenia [ Time Frame: 10-month follow-up (3 months after the intervention has ended) ] [ Designated as safety issue: No ]
- Expressed emotion in parents of patients with recent-onset schizophrenia [ Time Frame: 22-month follow-up (15 months after the intervention has ended) ] [ Designated as safety issue: No ]
| Enrollment: | 147 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | February 2011 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Family Motivational Intervention
An intervention provided to parents consisting of 6 sessions of training in Interactions Skills and 6 sessions training in Motivational Interviewing.
|
Behavioral: Family Motivational Intervention
A intervention with provided parents 6 sessions of Interaction Skills training and 6 sessions Motivational Interviewing training.
|
|
Active Comparator: Routine care for parents
Routine care for parents consisting of 2 sessions psycho-education and individual support
|
Behavioral: Family Motivational Intervention
A intervention with provided parents 6 sessions of Interaction Skills training and 6 sessions Motivational Interviewing training.
|
Eligibility| Ages Eligible for Study: | 16 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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:
-
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01167556
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167556
Locations
| Netherlands | |
| Academic Medical Center | |
| Amsterdam, North Holland, Netherlands, 1066 DP | |
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
| Study Director: | Gerard Schippers, Prof. dr. | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | |
| Principal Investigator: | Don Linszen, Prof.dr. | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | |
| Study Chair: | Lieuwe de Haan, Dr. | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
More Information
Publications:
| Responsible Party: | Don Linszen/ MD, PhD, AMC |
| ClinicalTrials.gov Identifier: | NCT01167556 History of Changes |
| Other Study ID Numbers: | Grant 100003014 |
| Study First Received: | July 20, 2010 |
| Last Updated: | July 21, 2010 |
| Health Authority: | Netherlands: ZonMw, Netherlands Organisation for Health Research and Development |
Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
|
Family intervention Recent-onset schizophrenia Motivational Interviewing Cannabis use |
Additional relevant MeSH terms:
|
Schizophrenia Mental Disorders Schizophrenia and Disorders with Psychotic Features |
ClinicalTrials.gov processed this record on February 27, 2015