Multidimensional family therapy (MDFT) treatment of adolescents with substance use disorders, focusing on risk and protective factors in major youth life domains

ISRCTN ISRCTN51014277
DOI https://doi.org/10.1186/ISRCTN51014277
Protocol serial number IST0808
Sponsor Erasmus Medical Centre (Netherlands)
Funders Federal Ministry of Health (Federaal Ministerie van Volksgezondheid) (Belgium), Federal Ministry of Health (Bundesministerium für Gesundheit) (Germany), The Inter-Departmental Mission for the Fight Against Drugs and Drug Addiction (Mission interministérielle de lutte contre la drogue et la toxicomanie [MILDT]) (France), Ministry of Health, Welfare and Sports (Ministerie van Volksgezondheid, Welzijn en Sport [VWS]) (Netherlands), Federal Office of Public Health (das Bundesamt für Gesundheit [BAG]) (Switzerland)
Submission date
08/03/2010
Registration date
17/03/2010
Last edited
28/08/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Henk Rigter
Scientific

Viviënstraat 24
The Hague
2582 RT
Netherlands

Study information

Primary study designInterventional
Study designMulticentre phase III(b) randomised controlled trial with an open-label, parallel group design
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleThe 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
Study acronymINCANT (International Cannabis Need of Treatment study)
Study objectivesAim:
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 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)
Health condition(s) or problem(s) studiedCannabis abuse and cannabis dependence
InterventionMDFT:
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 typeOther
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.

Key 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.

Completion date01/08/2010

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit13 Years
Upper age limit18 Years
SexAll
Target sample size at registration480
Key inclusion criteria1. 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)
Key exclusion criteria1. Disorder requiring hospitalisation or other residential treatment
2. Intelligence Quotient (IQ) of adolescent below 70
Date of first enrolment01/08/2007
Date of final enrolment01/08/2010

Locations

Countries of recruitment

  • Belgium
  • France
  • Germany
  • Netherlands
  • Switzerland

Study participating centre

Viviënstraat 24
The Hague
2582 RT
Netherlands

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 31/01/2014 Yes No
Results article results 17/08/2018 Yes No
Protocol article protocol 09/04/2010 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Study website Study website 11/11/2025 11/11/2025 No Yes

Editorial Notes

28/08/2018: Publication reference added.

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