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Family Motivational Intervention in Schizophrenia (FMI)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2008 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01167556
First Posted: July 22, 2010
Last Update Posted: July 22, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  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
Intervention Model: Parallel Assignment
Masking: Single (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) ]
  • Cannabis use in patients with a diagnosis of recent-onset schizophrenia [ Time Frame: 10-month follow-up (3 months after the intervention has ended) ]
  • Cannabis use in patients with a diagnosis of recent-onset schizophrenia [ Time Frame: 22-month follow-up (15 months after the intervention has ended) ]

Secondary Outcome Measures:
  • Medication adherence in patients with a diagnosis of recent-onset schizophrenia [ Time Frame: Baseline (before the start of the intervention) ]
  • Medication adherence in patients with a diagnosis of recent-onset schizophrenia [ Time Frame: 10-month follow-up (3 months after the intervention has ended) ]
  • Medication adherence in patients with a diagnosis of recent-onset schizophrenia [ Time Frame: 22-month follow-up (15 months after the intervention has ended) ]
  • Quality of life in patients with recent-onset schizophrenia [ Time Frame: Baseline (before the start of the intervention) ]
  • Quality of life in patients with recent-onset schizophrenia [ Time Frame: 10-month follow-up (3 months after the intervention has ended) ]
  • Quality of life in patients with recent-onset schizophrenia [ Time Frame: 22-month follow-up (15 months after the intervention has ended) ]
  • Stress in parents due to caring for a child with recent-onset schizophrenia [ Time Frame: Baseline (before the start of the intervention) ]
  • 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) ]
  • 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) ]
  • Expressed emotion in parents of patients with recent-onset schizophrenia [ Time Frame: Baseline (before the start of the intervention) ]
  • Expressed emotion in parents of patients with recent-onset schizophrenia [ Time Frame: 10-month follow-up (3 months after the intervention has ended) ]
  • Expressed emotion in parents of patients with recent-onset schizophrenia [ Time Frame: 22-month follow-up (15 months after the intervention has ended) ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: July 20, 2010
First Posted: July 22, 2010
Last Update Posted: July 22, 2010
Last Verified: February 2008

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
Marijuana Abuse
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders