Family Motivational Intervention in Schizophrenia (FMI)

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.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia; Cannabis
• Intervention / Treatment: Behavioral: Family Motivational Intervention

• Study Type: Interventional
• Enrollment (Actual): 147
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1066 DP
      • Academic Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cannabis use in patients with a diagnosis of recent-onset schizophrenia	Baseline (before the start of the intervention)
Cannabis use in patients with a diagnosis of recent-onset schizophrenia	10-month follow-up (3 months after the intervention has ended)
Cannabis use in patients with a diagnosis of recent-onset schizophrenia	22-month follow-up (15 months after the intervention has ended)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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)

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Anticipated): August 1, 2010
• Study Completion (Anticipated): February 1, 2011

Study Registration Dates

• First Submitted: July 20, 2010
• First Submitted That Met QC Criteria: July 21, 2010
• First Posted (Estimate): July 22, 2010

Study Record Updates

• Last Update Posted (Estimate): July 22, 2010
• Last Update Submitted That Met QC Criteria: July 21, 2010
• Last Verified: February 1, 2008

More Information

Terms related to this study

• Keywords: Motivational Interviewing; Cannabis use; Family intervention; Recent-onset schizophrenia
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Marijuana Abuse
• Other Study ID Numbers: Grant 100003014