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Family Motivational Intervention in Schizophrenia (FMI)

This study is enrolling participants by invitation only.
Sponsor:
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
History of Changes
  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:

U.S. FDA Resources

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
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:
Marijuana Abuse
Schizophrenia
Substance-Related Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on June 18, 2013