NCT01726361

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 7, 2013

Status Verified

November 1, 2013

Enrollment Period

2.6 years

First QC Date

November 9, 2012

Last Update Submit

November 6, 2013

Conditions

Adolescent BehaviourFamily Functioning

Keywords

Multidimension Treatment Foster CareAdolescentsDisadvantaged familiesOut-of-home placementConduct DisorderFamily programDenmarkYouth

Outcome Measures

Primary Outcomes (1)

  • Strengths and difficulties questionnaire, Child Behavior Checklist

    Measuring child/youth behaviour

    12 months post baseline

Secondary Outcomes (4)

  • Parental Stress Scale

    12 months post baseline

  • Sense of Cohesion 13

    12 months post baseline

  • Ladder of life

    12 months post baseline

  • Major Depression Index 10

    12 months post baseline

Other Outcomes (1)

  • Other outcomes

    12 months post baseline

Study Arms (2)

MTFC

EXPERIMENTAL

Out of home placement in MTFC family program

Behavioral: Multidimensional Treatment Foster Care

TAU

ACTIVE COMPARATOR

Other kind of out of home placement

Behavioral: Treatment as usual

Interventions

Multidimensional Treatment Foster CareBEHAVIORAL

Out of home placement in MTFC family for 10-12 months

MTFC
Treatment as usualBEHAVIORAL

Other kinds of out of home placement

Also known as: TAU
TAU

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years old
  • In need of out of home placement
  • serious behaviour problems

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SFI the Danish National Centre for Social Research

Copenhagen, 1052, Denmark

Location

MeSH Terms

Conditions

Conduct Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Mette Deding

    SFI the Danish National Centre for Social Research

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2012

First Posted

November 14, 2012

Study Start

November 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2016

Last Updated

November 7, 2013

Record last verified: 2013-11

Locations

DK(1)