Adolescent BehaviourPhase 4NCT01726361
Multidimensional Treatment Foster Care for Adolescents
A Phase 4 study testing Multidimensional Treatment Foster Care and Treatment as usual in people with Adolescent Behaviour and Family Functioning, run by VIVE - The Danish Center for Social Science Research at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Adolescent Behaviour, Family Functioning
- What is being tested?
- Multidimensional Treatment Foster Care and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2012to Jun 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 12-17 years old
- In need of out of home placement
- serious behaviour problems
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
SFI the Danish National Centre for Social Research
Copenhagen, 1052
About this study
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.
Read the detailed 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.
- Conditions
- Adolescent Behaviour, Family Functioning
- Being tested
- Multidimensional Treatment Foster Care, Treatment as usual
- Keywords
- Multidimension Treatment Foster Care, Adolescents, Disadvantaged families, Out-of-home placement, Conduct Disorder, Family program, Denmark, Youth
- Medical subject headings
- Conduct Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidimensional Treatment Foster CareBehavioural
Out of home placement in MTFC family for 10-12 months
Treatment as usualBehavioural
Also called TAU
Other kinds of out of home placement
| Study group | Role | What they receive |
|---|---|---|
| MTFC | Experimental | Out of home placement in MTFC family program Receives: Behavioral: Multidimensional Treatment Foster Care |
| TAU | Active comparator | Other kind of out of home placement Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strengths and difficulties questionnaire, Child Behavior Checklist
Measuring child/youth behaviour
Measured: 12 months post baseline
Secondary outcomes (4)
Parental Stress Scale
Measuring parental stress
Measured: 12 months post baseline
Sense of Cohesion 13
Measuring stress in human functioning
Measured: 12 months post baseline
Ladder of life
Measuring overall quality of life
Measured: 12 months post baseline
Major Depression Index 10
Measuring parent's depression symptoms
Measured: 12 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2015 (estimated)
- Study completionJun 2016 (estimated)
Why it stopped: We were not able to recruit families
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent BehaviourStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIVE - The Danish Center for Social Science Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Board of Social Services, Denmark, Ministry of Social Affairs, Denmark
- Responsible party
- Sponsor
- Investigators
- Mette Deding, Study director, SFI the Danish National Centre for Social Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726361
- Sponsor's protocol ID
- SFI 2506
- Status last verified
- Nov 2013
- First submitted
- 9 Nov 2012
- Last updated
- 7 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Treatment Foster Care for Adolescents
- ClinicalTrials.gov ID
- NCT01726361
- Acronym / sponsor ID
- SFI 2506
- Conditions
- Adolescent Behaviour, Family Functioning
- Keywords
- Multidimension Treatment Foster Care, Adolescents, Disadvantaged families, Out-of-home placement, Conduct Disorder, Family program, Denmark, Youth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We were not able to recruit families
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VIVE - The Danish Center for Social Science ResearchUniversity, hospital or other
- Collaborators
- National Board of Social Services, Denmark, Ministry of Social Affairs, Denmark
- Study start
- Nov 2012
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 14 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTFC | Experimental | Behavioral: Multidimensional Treatment Foster CareOut of home placement in MTFC family program |
| TAU | Active comparator | Behavioral: Treatment as usualOther kind of out of home placement |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 12-17 years old
- In need of out of home placement
- serious behaviour problems
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidimensional Treatment Foster CareOut of home placement in MTFC family for 10-12 months | Behavioural | MTFC |
| Treatment as usualAlso: TAUOther kinds of out of home placement | Behavioural | TAU |
Primary outcome
Strengths and difficulties questionnaire, Child Behavior Checklist
Time frame: 12 months post baseline
Measuring child/youth behaviour
4 secondary outcomes
Parental Stress Scale
Time frame: 12 months post baseline
Sense of Cohesion 13
Time frame: 12 months post baseline
Ladder of life
Time frame: 12 months post baseline
Major Depression Index 10
Time frame: 12 months post baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mette Deding study director
SFI the Danish National Centre for Social Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Multidimensional Treatment Foster Care and Treatment as usual in people with Adolescent Behaviour and Family Functioning, run by VIVE - The Danish Center for Social Science Research at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strengths and difficulties questionnaire, Child Behavior Checklist (time frame: 12 months post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2013.