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Family Motivational Intervention in Schizophrenia (FMI)

Primary Purpose

Cannabis, Schizophrenia

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Family Motivational Intervention
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis focused on measuring Family intervention, Recent-onset schizophrenia, Motivational Interviewing, Cannabis use

Eligibility Criteria

16 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

  • Academic Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Family Motivational Intervention

Routine care for parents

Arm Description

An intervention provided to parents consisting of 6 sessions of training in Interactions Skills and 6 sessions training in Motivational Interviewing.

Routine care for parents consisting of 2 sessions psycho-education and individual support

Outcomes

Primary Outcome Measures

Cannabis use in patients with a diagnosis of recent-onset schizophrenia
Cannabis use in patients with a diagnosis of recent-onset schizophrenia
Cannabis use in patients with a diagnosis of recent-onset schizophrenia

Secondary Outcome Measures

Medication adherence in patients with a diagnosis of recent-onset schizophrenia
Medication adherence in patients with a diagnosis of recent-onset schizophrenia
Medication adherence in patients with a diagnosis of recent-onset schizophrenia
Quality of life in patients with recent-onset schizophrenia
Quality of life in patients with recent-onset schizophrenia
Quality of life in patients with recent-onset schizophrenia
Stress in parents due to caring for a child with recent-onset schizophrenia
Stress in parents due to caring for a child with recent-onset schizophrenia
Stress in parents due to caring for a child with recent-onset schizophrenia
Expressed emotion in parents of patients with recent-onset schizophrenia
Expressed emotion in parents of patients with recent-onset schizophrenia
Expressed emotion in parents of patients with recent-onset schizophrenia

Full Information

First Posted
July 20, 2010
Last Updated
July 21, 2010
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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1. Study Identification

Unique Protocol Identification Number
NCT01167556
Brief Title
Family Motivational Intervention in Schizophrenia
Acronym
FMI
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 Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2006 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
February 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis, Schizophrenia
Keywords
Family intervention, Recent-onset schizophrenia, Motivational Interviewing, Cannabis use

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Family Motivational Intervention
Arm Type
Experimental
Arm Description
An intervention provided to parents consisting of 6 sessions of training in Interactions Skills and 6 sessions training in Motivational Interviewing.
Arm Title
Routine care for parents
Arm Type
Active Comparator
Arm Description
Routine care for parents consisting of 2 sessions psycho-education and individual support
Intervention Type
Behavioral
Intervention Name(s)
Family Motivational Intervention
Intervention Description
A intervention with provided parents 6 sessions of Interaction Skills training and 6 sessions Motivational Interviewing training.
Primary Outcome Measure Information:
Title
Cannabis use in patients with a diagnosis of recent-onset schizophrenia
Time Frame
Baseline (before the start of the intervention)
Title
Cannabis use in patients with a diagnosis of recent-onset schizophrenia
Time Frame
10-month follow-up (3 months after the intervention has ended)
Title
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 Measure Information:
Title
Medication adherence in patients with a diagnosis of recent-onset schizophrenia
Time Frame
Baseline (before the start of the intervention)
Title
Medication adherence in patients with a diagnosis of recent-onset schizophrenia
Time Frame
10-month follow-up (3 months after the intervention has ended)
Title
Medication adherence in patients with a diagnosis of recent-onset schizophrenia
Time Frame
22-month follow-up (15 months after the intervention has ended)
Title
Quality of life in patients with recent-onset schizophrenia
Time Frame
Baseline (before the start of the intervention)
Title
Quality of life in patients with recent-onset schizophrenia
Time Frame
10-month follow-up (3 months after the intervention has ended)
Title
Quality of life in patients with recent-onset schizophrenia
Time Frame
22-month follow-up (15 months after the intervention has ended)
Title
Stress in parents due to caring for a child with recent-onset schizophrenia
Time Frame
Baseline (before the start of the intervention)
Title
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)
Title
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)
Title
Expressed emotion in parents of patients with recent-onset schizophrenia
Time Frame
Baseline (before the start of the intervention)
Title
Expressed emotion in parents of patients with recent-onset schizophrenia
Time Frame
10-month follow-up (3 months after the intervention has ended)
Title
Expressed emotion in parents of patients with recent-onset schizophrenia
Time Frame
22-month follow-up (15 months after the intervention has ended)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerard Schippers, Prof. dr.
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Don Linszen, Prof.dr.
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lieuwe de Haan, Dr.
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Study Chair
Facility Information:
Facility Name
Academic Medical Center
City
Amsterdam
State/Province
North Holland
ZIP/Postal Code
1066 DP
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
19917142
Citation
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.
Results Reference
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Family Motivational Intervention in Schizophrenia

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