Family Motivational Intervention in Schizophrenia

Study Overview
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Brief Summary
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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.

Official Title
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Motivational Interviewing and Interaction Skills Training for Carers to Change Cannabis Use in Young Adults With Recent-onset Schizophrenia: Randomised Controlled Trial

Conditions
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Cannabis, Schizophrenia

Intervention / Treatment
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* Behavioral: Family Motivational Intervention


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family Motivational Intervention<br>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<br>* A intervention with provided parents 6 sessions of Interaction Skills training and 6 sessions Motivational Interviewing training.<br>|
| Active Comparator: Routine care for parents<br>Routine care for parents consisting of 2 sessions psycho-education and individual support | Behavioral: Family Motivational Intervention<br>* A intervention with provided parents 6 sessions of Interaction Skills training and 6 sessions Motivational Interviewing training.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Family intervention, Recent-onset schizophrenia, Motivational Interviewing, Cannabis use