Children and Adolescents in Foster Care and Residential CareNCT02220179
Resilience for Children and Young People in Foster Care and Residential Care in Denmark
A study testing The Resilience Program in people with Children and Adolescents in Foster Care and Residential Care, run by Poul Bak at 1 site in Denmark.
Trial summary
In this project we invite 9.000 children and young persons in Denmark and their foster parents and staff at the residential institutions to participate in a cluster randomized controlled intervention study where we aim to test the effectiveness of a web based knowledge and inspiration program about resilience for… Read more about this study
- Who is it for?
- Ages Up to 23 years
- Conditions the study is for
- Children and Adolescents in Foster Care and Residential Care
- What is being tested?
- The Resilience Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,000 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2014to Aug 2017
- Phase
- Interventional
- 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 Up to 23 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All children and adolescents registered in foster care in Denmark on august 11th 2014.
- All children and adolescents registered in residential care in Denmark on august 11th 2014.
Who cannot join
- Request for legal protection against contacts from researchers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resilience for Children and Young People
In this project we invite 9.000 children and young persons in Denmark and their foster parents and staff at the residential institutions to participate in a cluster randomized controlled intervention study where we aim to test the effectiveness of a web based knowledge and inspiration program about resilience for children, adolescents and adults (called myresilience.org). The complete CONSORT trial protocol is available at http://myresilience.org/ at the subsite 'about us'.
Read the detailed description
The complete CONSORT trial protocol is available at http://myresilience.org/ at the subsite 'about us'.
- Being tested
- The Resilience Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Resilience ProgramBehavioural
Se the CONSORT trial protocol at http://myresilience.org/ at the subsite 'about us'
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | service as usual |
| Intervention group 1 | Experimental | Participants are offered access to the web based resilience program Receives: Behavioral: The Resilience Program |
| Intervention group 2 | Experimental | Participants are offered access to the web based resilience program and are also invited to join a short introduction course about the program Receives: Behavioral: The Resilience Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
National Test in Danish Reading
The National test in danish reading is a standard performance test which is mandatory for all danish student. It is administered for every other year.
Measured: Outcome data will be collected on the average 2 years after intervention
Secondary outcomes (1)
The frequency of Care collapse
All incidents of collapse in a care relation is registered by the danish authorities. The informations in this register are used for this outcome measure.
Measured: Outcome data will be collected on the average 2 years after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children and Adolescents in Foster Care and Residential CareStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 9,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poul Bak
- Sponsor type
- University, hospital or other
- Collaborators
- TRYG Foundation
- Responsible party
- Sponsor-investigator, Poul Bak, University of Aarhus
- Investigators
- Poul L Bak, MD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220179
- Sponsor's protocol ID
- DK-res-care
- Status last verified
- Jun 2015
- First submitted
- 15 Aug 2014
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resilience for Children and Young People
- ClinicalTrials.gov ID
- NCT02220179
- Acronym / sponsor ID
- DK-res-care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9,000 participants (estimated)
- Lead sponsor
- Poul BakUniversity, hospital or other
- Collaborators
- TRYG Foundation
- Study start
- Aug 2014
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 19 Aug 2014 (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.
In this project we invite 9.000 children and young persons in Denmark and their foster parents and staff at the residential institutions to participate in a cluster randomized controlled intervention study where we aim to test the effectiveness of a web based knowledge and inspiration program about resilience for children, adolescents and adults (called myresilience.org). The complete CONSORT trial protocol is available at http://myresilience.org/ at the subsite 'about us'.
Detailed description
The complete CONSORT trial protocol is available at http://myresilience.org/ at the subsite 'about us'.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –service as usual |
| Intervention group 1 | Experimental | Behavioral: The Resilience ProgramParticipants are offered access to the web based resilience program |
| Intervention group 2 | Experimental | Behavioral: The Resilience ProgramParticipants are offered access to the web based resilience program and are also invited to join a short introduction course about the program |
Who may qualify
- Ages
- Up to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- All children and adolescents registered in foster care in Denmark on august 11th 2014.
- All children and adolescents registered in residential care in Denmark on august 11th 2014.
Key exclusion criteria (1 listed)
- Request for legal protection against contacts from researchers.
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 |
|---|---|---|
| The Resilience ProgramSe the CONSORT trial protocol at http://myresilience.org/ at the subsite 'about us' | Behavioural | Intervention group 1, Intervention group 2 |
Primary outcome
National Test in Danish Reading
Time frame: Outcome data will be collected on the average 2 years after intervention
The National test in danish reading is a standard performance test which is mandatory for all danish student. It is administered for every other year.
1 secondary outcome
The frequency of Care collapse
Time frame: Outcome data will be collected on the average 2 years after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
- Find the CONSORT trial protocol on the subsite 'about us'Link provided by the sponsor.
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.
Poul L Bak, MD principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Resilience Program in people with Children and Adolescents in Foster Care and Residential Care, run by Poul Bak 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Jun 2015. 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.
Are results available for this study?
Results are not available in the source record.
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?
National Test in Danish Reading (time frame: Outcome data will be collected on the average 2 years after intervention). 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 2 Jun 2015.