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| [ Print-friendly version ] |
| Multidimensional family therapy (MDFT) treatment of adolescents with substance use disorders, focusing on risk and protective factors in major youth life domains |
| ISRCTN | ISRCTN51014277 |
| ClinicalTrials.gov identifier | |
| Public title | Multidimensional family therapy (MDFT) treatment of adolescents with substance use disorders, focusing on risk and protective factors in major youth life domains |
| 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) |
| Serial number at source | IST0808 |
| 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 |
| Lay summary | |
| Ethics approval |
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 d’”Ethique 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 |
| Countries of recruitment | Belgium, France, Germany, Netherlands, Switzerland |
| Disease/condition/study domain | Cannabis abuse and cannabis dependence |
| Participants - 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) |
| Participants - exclusion criteria |
1. Disorder requiring hospitalisation or other residential treatment
2. Intelligence Quotient (IQ) of adolescent below 70 |
| Anticipated start date | 01/08/2007 |
| Anticipated end date | 01/08/2010 |
| Status of trial | Completed |
| Patient information material | Can be found at http://incant.eu |
| Target number of participants | 480 |
| Interventions |
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. |
| Primary outcome measure(s) |
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 measure(s) |
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. |
| Sources of funding |
1. Federal Ministry of Health (Federaal Ministerie van Volksgezondheid) (Belgium)
2. Federal Ministry of Health (Bundesministerium für Gesundheit) (Germany) 3. The Inter-Departmental Mission for the Fight Against Drugs and Drug Addiction (Mission interministérielle de lutte contre la drogue et la toxicomanie [MILDT]) (France) 4. Ministry of Health, Welfare and Sports (Ministerie van Volksgezondheid, Welzijn en Sport [VWS]) (Netherlands) 5. Federal Office of Public Health (das Bundesamt für Gesundheit [BAG]) (Switzerland) |
| Trial website | http://incant.eu |
| Publications | 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20380718 |
| Contact name | Dr Henk Rigter |
| Address | Viviënstraat 24 |
| City/town | The Hague |
| Zip/Postcode | 2582 RT |
| Country | Netherlands |
| Sponsor | Erasmus Medical Centre (Netherlands) |
| Address |
c/o Dr Henk Rigter
Department of Public Health, Ae-233 P.O. Box 2040 |
| City/town | Rotterdam |
| Zip/Postcode | 3000 CA |
| Country | Netherlands |
| Sponsor website: | http://www.erasmusmc.nl/ |
| Date applied | 08/03/2010 |
| Last edited | 26/05/2010 |
| Date ISRCTN assigned | 17/03/2010 |
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