INCANT: a transnational randomized trial of Multidimensional Family Therapy versus treatment as usual for adolescents with cannabis use disorder

BACKGROUND: In 2003, the governments of Belgium, France, Germany, the Netherlands and Switzerland agreed that there was a need in Europe for a treatment programme for adolescents with cannabis use disorders and other behavioural problems. Based on an exhaustive literature review of evidence-based treatments and an international experts meeting, Multidimensional Family Therapy (MDFT) was selected for a pilot study first, which was successful, and then for a joint, transnational randomized controlled trial named INCANT (INternational CAnnabis Need for Treatment). METHODS/DESIGN: INCANT is a randomized controlled trial (RCT) with an open-label, parallel group design. This study compares MDFT with treatment as usual (TAU) at and across sites in Brussels, Berlin, Paris, The Hague and Geneva. Assessments are at baseline and at 3, 6, 9 and 12 months after randomization. A minimum of 450 cases in total is required; sites will recruit 60 cases each in Belgium and Switzerland, and a maximum of 120 each in France, Germany and the Netherlands. Eligible for INCANT are adolescents from 13 through 18 years of age with a cannabis use disorder (dependence or abuse), with at least one parent willing to take part in the treatment. Randomization is concealed to, and therefore beyond control by, the researcher/site requesting it. Randomization is stratified as to gender, age and level of cannabis consumption. Assessments focus on substance use; mental function; behavioural problems; and functioning regarding family, school, peers and leisure time. For outcome analyses, the study will use state of the art latent growth curve modelling techniques, including all randomized participants according to the intention-to-treat principle. INCANT has been approved by the appropriate ethical boards in Belgium, France, Germany, the Netherlands, Switzerland, and the University of Miami Miller School of Medicine. INCANT is funded by the (federal) Ministries of Health of Belgium, Germany, the Netherlands, Switzerland, and by MILDT: the Mission Interministerielle de Lutte Contra la Drogue et de Toximanie, France. DISCUSSION: Until recently, cannabis use disorders in adolescents were not viewed in Europe as requiring treatment, and the co-occurrence of such disorders with other mental and behavioural problems was underestimated. This has changed now. Initially, there was doubt that a RCT would be feasible in treatment sectors and countries with no experience in this type of study. INCANT has proven that such doubts are unjustified. Governments and treatment sites from the five participating countries agreed on a sound study protocol, and the INCANT trial is now underway as planned. TRIAL REGISTRATION: ISRCTN51014277