Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
IST0808
Study information
Scientific title
The effectiveness of outpatient multidimensional family therapy (MDFT) compared with outpatient treatment as usual in adolescents with a cannabis use disorder and other problem behaviour: a multicentre, trans-national randomised controlled trial
Acronym
INCANT (International Cannabis Need of Treatment study)
Study hypothesis
Aim:
To examine if multidimensional family therapy (MDFT) is superior to treatment as usual in reducing substance abuse (notably cannabis) and other problem behaviour in adolescents. This is a multicentre trial, with sites in Brussels, Berlin, Paris, The Hague and Geneva.
Primary hypotheses:
1. Youths assigned to MDFT will diminish their use of cannabis more than youths in the treatment as usual condition between baseline and 4 follow-up assessments spaced across a 1-year follow-up period
2. Youths assigned to MDFT will be less likely to meet diagnostic criteria of cannabis disorders going from baseline to the 12 months follow-up assessment than youths treated as usual
Ethics approval(s)
1. Belgium: Comité dÉthique Hospitalier approved on the 8th August 2006 (ref: CE2006/39)
2. France: Comité Consultatif de Protection des Personnes dans la Recherche Biomedicale approved on the 28th August 2006 (ref: 0611357)
3. Germany: Kammer für Psychologische Psychotherapeuten und Kinder- und Jugendlichenpsychotherapeuten im Land Berlin approved on the 19th September 2006
4. Netherlands: Medisch-ethische Toetsingscommissie Instellingen Geestelijke Gezondheidszorg (METiGG) approved on the 9th May 2006 (ref: 5238)
5. Switzerland: Association des Médecins du Canton de Genève et Societé Médicale Commission dEthique pour la Recherche Clinique en Ambulatoire approved on the 6th February 2007 (ref: 07-02)
6. USA (Miami): Institutional Review Board of University of Miami Miller School of Medicine, Human Subjects Research Office approved on the 21st September 2006 (ref: 20060330)
Study design
Multicentre phase III(b) randomised controlled trial with an open-label, parallel group design
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Other
Study type
Treatment
Patient information sheet
Can be found at http://incant.eu
Condition
Cannabis abuse and cannabis dependence
Intervention
MDFT:
4 - 6 months; sessions 2 - 3 times a week. Office-based and home-based sessions with:
1. The adolescent alone
2. The parent(s) alone
3. The family = adolescent + parent(s), and
4. Representatives of other social systems (friends, school, or probation) present
Treatment as usual (TAU):
This differs between countries to reflect local practice, but is based on cognitive-behavioural therapy and it matches MDFT in duration. In France and the Netherlands, TAU has been manualised.
Intervention type
Other
Primary outcome measure
1. MDFT reduces cannabis consumption more strongly than TAU in the 90-day periods preceding follow-up assessments points (a lower number of consumption days: TLFB = TimeLine Follow Back), the difference growing bigger over time
2. Number of urine tests indicative of cannabis use is lower in MDFT than in TAU at follow-up assessments points
3. In MDFT, youth show fewer (symptoms of) diagnoses of cannabis use disorders (as measured with the Adolescent Diagnostic Interview-Light [ADI-Light]) than in TAU at 12 months follow-up (the validated ADI-Light measures symptoms of substance use disorders). Assessment points: baseline, 12 months follow up.
Secondary outcome measures
1. MDFT reduces alcohol consumption to a greater extent than TAU, on the same measures and the same assessment points as outlined for cannabis
2. MDFT is superior to TAU in diminishing delinquent behaviour (less recidivism), as measured with the validated Adolescent and Parent Interviews, the Self-Reported Delinquency survey (SRD; lower score), lower scores on the delinquency sub-scales of Youth-Self Report (YSR) and its parent version, the Child Behaviour Checklist (CBCL). Also police and justice registration databases. Assessment points: baseline, 6 months and 12 months follow up.
3. MDFT improves family functioning more than TAU (validated Adolescent and Parent Interviews using the Family Environment Scale [FES]). Interviews: baseline, 6 months and 12 months follow-up. FES: idem, but also 9-months follow up.
4. MDFT improves the youth's performance at school or work more than TAU (validated Adolescent and Parent Interviews, school reports, truancy logs). Assessment points: baseline, 6 months and 12 months follow up.
Overall study start date
01/08/2007
Overall study end date
01/08/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age of the adolescent 13 through 18 years, either sex
2. Diagnosis of cannabis use disorder
3. At least 1 parent willing to take part in the treatment programme
4. Informed consent by both adolescent and parent(s)
Participant type(s)
Patient
Age group
Child
Lower age limit
13 Years
Upper age limit
18 Years
Sex
Both
Target number of participants
480
Participant exclusion criteria
1. Disorder requiring hospitalisation or other residential treatment
2. Intelligence Quotient (IQ) of adolescent below 70
Recruitment start date
01/08/2007
Recruitment end date
01/08/2010
Locations
Countries of recruitment
Belgium, France, Germany, Netherlands, Switzerland
Study participating centre
Viviënstraat 24
The Hague
2582 RT
Netherlands
Sponsor information
Organisation
Erasmus Medical Centre (Netherlands)
Sponsor details
c/o Dr Henk Rigter
Department of Public Health
Ae-233
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
Sponsor type
Government
Website
ROR
Funders
Funder type
Government
Funder name
Federal Ministry of Health (Federaal Ministerie van Volksgezondheid) (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Federal Ministry of Health (Bundesministerium für Gesundheit) (Germany)
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Funding Body Type
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Location
Funder name
The Inter-Departmental Mission for the Fight Against Drugs and Drug Addiction (Mission interministérielle de lutte contre la drogue et la toxicomanie [MILDT]) (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Ministry of Health, Welfare and Sports (Ministerie van Volksgezondheid, Welzijn en Sport [VWS]) (Netherlands)
Alternative name(s)
Funding Body Type
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Location
Funder name
Federal Office of Public Health (das Bundesamt für Gesundheit [BAG]) (Switzerland)
Alternative name(s)
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Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 09/04/2010 | Yes | No | |
| Results article | results | 31/01/2014 | Yes | No | |
| Results article | results | 17/08/2018 | Yes | No |