CannabisFMINCT01167556
Family Motivational Intervention in Schizophrenia
A study testing Family Motivational Intervention in people with Cannabis and Schizophrenia, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Cannabis, Schizophrenia
- What is being tested?
- Family Motivational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2006to Feb 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academic Medical Center
Amsterdam, North Holland, 1066 DP
About this study
Official title: 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.
- Conditions
- Cannabis, Schizophrenia
- Being tested
- Family Motivational Intervention
- Keywords
- Family intervention, Recent-onset schizophrenia, Motivational Interviewing, Cannabis use
- Medical subject headings
- Marijuana Abuse, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Motivational InterventionBehavioural
A intervention with provided parents 6 sessions of Interaction Skills training and 6 sessions Motivational Interviewing training.
| Study group | Role | What they receive |
|---|---|---|
| Family Motivational Intervention | Experimental | An intervention provided to parents consisting of 6 sessions of training in Interactions Skills and 6 sessions training in Motivational Interviewing. Receives: Behavioral: Family Motivational Intervention |
| Routine care for parents | Active comparator | Routine care for parents consisting of 2 sessions psycho-education and individual support Receives: Behavioral: Family Motivational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cannabis use in patients with a diagnosis of recent-onset schizophrenia
Measured: Baseline (before the start of the intervention)
Cannabis use in patients with a diagnosis of recent-onset schizophrenia
Measured: 10-month follow-up (3 months after the intervention has ended)
Cannabis use in patients with a diagnosis of recent-onset schizophrenia
Measured: 22-month follow-up (15 months after the intervention has ended)
Secondary outcomes (12)
Medication adherence in patients with a diagnosis of recent-onset schizophrenia
Measured: Baseline (before the start of the intervention)
Medication adherence in patients with a diagnosis of recent-onset schizophrenia
Measured: 10-month follow-up (3 months after the intervention has ended)
Medication adherence in patients with a diagnosis of recent-onset schizophrenia
Measured: 22-month follow-up (15 months after the intervention has ended)
Quality of life in patients with recent-onset schizophrenia
Measured: Baseline (before the start of the intervention)
Quality of life in patients with recent-onset schizophrenia
Measured: 10-month follow-up (3 months after the intervention has ended)
Quality of life in patients with recent-onset schizophrenia
Measured: 22-month follow-up (15 months after the intervention has ended)
Stress in parents due to caring for a child with recent-onset schizophrenia
Measured: Baseline (before the start of the intervention)
Stress in parents due to caring for a child with recent-onset schizophrenia
Measured: 10-month follow-up (3 months after the intervention has ended)
Stress in parents due to caring for a child with recent-onset schizophrenia
Measured: 22-month follow-up (15 months after the intervention has ended)
Expressed emotion in parents of patients with recent-onset schizophrenia
Measured: Baseline (before the start of the intervention)
Expressed emotion in parents of patients with recent-onset schizophrenia
Measured: 10-month follow-up (3 months after the intervention has ended)
Expressed emotion in parents of patients with recent-onset schizophrenia
Measured: 22-month follow-up (15 months after the intervention has ended)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startMar 2006
- Primary completionAug 2010 (estimated)
- Study completionFeb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CannabisStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Gerard Schippers, Prof. dr., Study director, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Don Linszen, Prof.dr., Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Lieuwe de Haan, Dr., Study chair, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167556
- Sponsor's protocol ID
- Grant 100003014
- Acronym
- FMI
- Status last verified
- Feb 2008
- First submitted
- 20 Jul 2010
- Last updated
- 22 Jul 2010
- Results posted
- No
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.
PubMed 19917142
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing and Interaction Skills Training for Carers to Change Cannabis Use in Young Adults With Recent-onset Schizophrenia: Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01167556
- Acronym / sponsor ID
- FMI / Grant 100003014
- Conditions
- Cannabis, Schizophrenia
- Keywords
- Family intervention, Recent-onset schizophrenia, Motivational Interviewing, Cannabis use
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Mar 2006
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 22 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Motivational Intervention | Experimental | Behavioral: Family Motivational InterventionAn intervention provided to parents consisting of 6 sessions of training in Interactions Skills and 6 sessions training in Motivational Interviewing. |
| Routine care for parents | Active comparator | Behavioral: Family Motivational InterventionRoutine care for parents consisting of 2 sessions psycho-education and individual support |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Motivational InterventionA intervention with provided parents 6 sessions of Interaction Skills training and 6 sessions Motivational Interviewing training. | Behavioural | Family Motivational Intervention, Routine care for parents |
Primary outcome
Cannabis use in patients with a diagnosis of recent-onset schizophrenia
Time frame: Baseline (before the start of the intervention)
Cannabis use in patients with a diagnosis of recent-onset schizophrenia
Time frame: 10-month follow-up (3 months after the intervention has ended)
Cannabis use in patients with a diagnosis of recent-onset schizophrenia
Time frame: 22-month follow-up (15 months after the intervention has ended)
12 secondary outcomes
Medication adherence in patients with a diagnosis of recent-onset schizophrenia
Time frame: Baseline (before the start of the intervention)
Medication adherence in patients with a diagnosis of recent-onset schizophrenia
Time frame: 10-month follow-up (3 months after the intervention has ended)
Medication adherence in patients with a diagnosis of recent-onset schizophrenia
Time frame: 22-month follow-up (15 months after the intervention has ended)
Quality of life in patients with recent-onset schizophrenia
Time frame: Baseline (before the start of the intervention)
Quality of life in patients with recent-onset schizophrenia
Time frame: 10-month follow-up (3 months after the intervention has ended)
Quality of life in patients with recent-onset schizophrenia
Time frame: 22-month follow-up (15 months after the intervention has ended)
Stress in parents due to caring for a child with recent-onset schizophrenia
Time frame: Baseline (before the start of the intervention)
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)
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)
Expressed emotion in parents of patients with recent-onset schizophrenia
Time frame: Baseline (before the start of the intervention)
Expressed emotion in parents of patients with recent-onset schizophrenia
Time frame: 10-month follow-up (3 months after the intervention has ended)
Expressed emotion in parents of patients with recent-onset schizophrenia
Time frame: 22-month follow-up (15 months after the intervention has ended)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2010.
- Background: PubMed 19917142Dekker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerard Schippers, Prof. dr. study director
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Don Linszen, Prof.dr. principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lieuwe de Haan, Dr. study chair
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Motivational Intervention in people with Cannabis and Schizophrenia, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cannabis use in patients with a diagnosis of recent-onset schizophrenia (time frame: Baseline (before the start of the intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01167556, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2010.