- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02220179
Resilience for Children and Young People in Foster Care and Residential Care in Denmark
June 1, 2015 updated by: Poul Bak
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'.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
The complete CONSORT trial protocol is available at http://myresilience.org/ at the subsite 'about us'.
Study Type
Interventional
Enrollment (Anticipated)
9000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aarhus, Denmark, 8000
- Aarhus University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 23 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
• Request for legal protection against contacts from researchers.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control
service as usual
|
|
Experimental: Intervention group 1
Participants are offered access to the web based resilience program
|
Se the CONSORT trial protocol at http://myresilience.org/ at the subsite 'about us'
|
Experimental: Intervention group 2
Participants are offered access to the web based resilience program and are also invited to join a short introduction course about the program
|
Se the CONSORT trial protocol at http://myresilience.org/ at the subsite 'about us'
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Outcome data will be collected on the average 2 years after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The frequency of Care collapse
Time Frame: Outcome data will be collected on the average 2 years after intervention
|
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.
|
Outcome data will be collected on the average 2 years after intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Questionnaire data
Time Frame: data collected august 2015
|
Se the trial CONSORT protocol at http://myresilience.org/ at the subsite 'about us'
|
data collected august 2015
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Poul L Bak, MD, University of Aarhus
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Anticipated)
August 1, 2017
Study Completion (Anticipated)
August 1, 2017
Study Registration Dates
First Submitted
August 15, 2014
First Submitted That Met QC Criteria
August 18, 2014
First Posted (Estimate)
August 19, 2014
Study Record Updates
Last Update Posted (Estimate)
June 2, 2015
Last Update Submitted That Met QC Criteria
June 1, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- DK-res-care
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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