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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01726361
Other study ID # SFI 2506
Secondary ID
Status Withdrawn
Phase Phase 4
First received November 9, 2012
Last updated November 6, 2013
Start date November 2012
Est. completion date June 2016

Study information

Verified date November 2013
Source The Danish National Centre For Social Research
Contact n/a
Is FDA regulated No
Health authority Denmark:SFI the Danish National Centre for Social Research
Study type Interventional

Clinical Trial Summary

The purpose of the study is to examine the effects of Multidimensional Treatment Foster Care compared to treatment as usual (TAU) for adolescents in Denmark in need of out-of-home placement.


Description:

It is difficult to treat adolescents with serious behaviour problems. Although the number of adolescents displaying serious behaviour problems is limited, they are a serious concern to the society e.g. because of their frequent violent behaviour, criminal activities and lack of school adherence.

Multidimensional Treatment Foster Care (MTFC)is a community-based treatment program developed in USA. The goal of the MTFC program is to decrease problem behaviour and to increase developmentally appropriate normative and prosocial behavior in adolescents who are in need of out-of-home placement.

This study will evaluate the effect of MTFC on adolescents in out-of-home placement.

Participants will be recruited by caseworkers in the municipalities and randomly assigned to either MTFC or TAU. TAU will consist of other kinds of out-of-home placements. Outcomes will be assessed for all participants at baseline, post-treatment (12 months), and 12 months post-treatment. Parents and youth will be asked to fill out questionnaires on e.g. behaviour, parental stress, sense of cohesion, general health.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2016
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 17 Years
Eligibility Inclusion Criteria:

- 12-17 years old

- In need of out of home placement

- serious behaviour problems

Exclusion Criteria:

- severe psychiatric illness in youth or parent

- risk of suicide in youth

- acute psychosis in youth

- sexual offence by youth

- severe substance abuse in youth or parent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Multidimensional Treatment Foster Care
Out of home placement in MTFC family for 10-12 months
Treatment as usual
Other kinds of out of home placement

Locations

Country Name City State
Denmark SFI the Danish National Centre for Social Research Copenhagen

Sponsors (3)

Lead Sponsor Collaborator
The Danish National Centre For Social Research Ministry of Social Affairs, Denmark, National Board of Social Services, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Other outcomes crime (register and self-report) school truancy (register and self-report) general health including substance abuse (self-report) 12 months post baseline No
Primary Strengths and difficulties questionnaire, Child Behavior Checklist Measuring child/youth behaviour 12 months post baseline No
Secondary Parental Stress Scale Measuring parental stress 12 months post baseline No
Secondary Sense of Cohesion 13 Measuring stress in human functioning 12 months post baseline No
Secondary Ladder of life Measuring overall quality of life 12 months post baseline No
Secondary Major Depression Index 10 Measuring parent's depression symptoms 12 months post baseline No
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