NCT02220179

Brief 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 children, adolescents and adults (called myresilience.org). The complete CONSORT trial protocol is available at http://myresilience.org/ at the subsite 'about us'.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
9,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2014

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

June 2, 2015

Status Verified

June 1, 2015

Enrollment Period

3 years

First QC Date

August 15, 2014

Last Update Submit

June 1, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Outcome data will be collected on the average 2 years after intervention

Secondary Outcomes (1)

  • The frequency of Care collapse

    Outcome data will be collected on the average 2 years after intervention

Other Outcomes (1)

  • Questionnaire data

    data collected august 2015

Study Arms (3)

control

NO INTERVENTION

service as usual

Intervention group 1

EXPERIMENTAL

Participants are offered access to the web based resilience program

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

Behavioral: The Resilience Program

Interventions

Se the CONSORT trial protocol at http://myresilience.org/ at the subsite 'about us'

Intervention group 1Intervention group 2

Eligibility Criteria

AgeUp to 23 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Request for legal protection against contacts from researchers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University

Aarhus, Denmark, 8000, Denmark

Location

Related Links

Study Officials

  • Poul L Bak, MD

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 15, 2014

First Posted

August 19, 2014

Study Start

August 1, 2014

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

June 2, 2015

Record last verified: 2015-06

Locations