Family Motivational Intervention in Schizophrenia (FMI)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Cannabis; Schizophrenia	Behavioral: Family Motivational Intervention	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	147 participants
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
Study Start Date :	March 2006
Estimated Primary Completion Date :	August 2010
Estimated Study Completion Date :	February 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Cannabis use in patients with a diagnosis of recent-onset schizophrenia [ Time Frame: Baseline (before the start of the intervention) ]
2. Cannabis use in patients with a diagnosis of recent-onset schizophrenia [ Time Frame: 10-month follow-up (3 months after the intervention has ended) ]
3. 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 :

1. Medication adherence in patients with a diagnosis of recent-onset schizophrenia [ Time Frame: Baseline (before the start of the intervention) ]
2. Medication adherence in patients with a diagnosis of recent-onset schizophrenia [ Time Frame: 10-month follow-up (3 months after the intervention has ended) ]
3. Medication adherence in patients with a diagnosis of recent-onset schizophrenia [ Time Frame: 22-month follow-up (15 months after the intervention has ended) ]
4. Quality of life in patients with recent-onset schizophrenia [ Time Frame: Baseline (before the start of the intervention) ]
5. Quality of life in patients with recent-onset schizophrenia [ Time Frame: 10-month follow-up (3 months after the intervention has ended) ]
6. Quality of life in patients with recent-onset schizophrenia [ Time Frame: 22-month follow-up (15 months after the intervention has ended) ]
7. Stress in parents due to caring for a child with recent-onset schizophrenia [ Time Frame: Baseline (before the start of the intervention) ]
8. 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) ]
9. 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) ]
10. Expressed emotion in parents of patients with recent-onset schizophrenia [ Time Frame: Baseline (before the start of the intervention) ]
11. Expressed emotion in parents of patients with recent-onset schizophrenia [ Time Frame: 10-month follow-up (3 months after the intervention has ended) ]
12. Expressed emotion in parents of patients with recent-onset schizophrenia [ Time Frame: 22-month follow-up (15 months after the intervention has ended) ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Dekker N, Smeerdijk AM, Wiers RW, Duits JH, van Gelder G, Houben K, Schippers G, Linszen DH, de Haan L. Implicit and explicit affective associations towards cannabis use in patients with recent-onset schizophrenia and healthy controls. Psychol Med. 2010 Aug;40(8):1325-36. doi: 10.1017/S0033291709991814. Epub 2009 Nov 17.

Responsible Party:	Don Linszen/ MD, PhD, AMC
ClinicalTrials.gov Identifier:	NCT01167556 History of Changes
Other Study ID Numbers:	Grant 100003014
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