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 |
| Secondary identifying numbers | IST0808 |
- 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
Not provided at time of registration
Contact information
Dr Henk Rigter
Scientific
Scientific
Viviënstraat 24
The Hague
2582 RT
Netherlands
Study information
| 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 |
| Participant information sheet | Can be found at http://incant.eu |
| 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 |
| Study 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) |
| 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 |
Eligibility
| 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 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 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
2582 RT
Netherlands
Sponsor information
Erasmus Medical Centre (Netherlands)
Government
Government
c/o Dr Henk Rigter
Department of Public Health, Ae-233
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
| Website | http://www.erasmusmc.nl/ |
|---|---|
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Government
Federal Ministry of Health (Federaal Ministerie van Volksgezondheid) (Belgium)
No information available
Federal Ministry of Health (Bundesministerium für Gesundheit) (Germany)
No information available
The Inter-Departmental Mission for the Fight Against Drugs and Drug Addiction (Mission interministérielle de lutte contre la drogue et la toxicomanie [MILDT]) (France)
No information available
Ministry of Health, Welfare and Sports (Ministerie van Volksgezondheid, Welzijn en Sport [VWS]) (Netherlands)
No information available
Federal Office of Public Health (das Bundesamt für Gesundheit [BAG]) (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
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 |
Editorial Notes
28/08/2018: Publication reference added.
