NCT02220140

Brief Summary

In this project we invite 8.000 young persons (age 18-27) in Denmark and to participate in a 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
8,000

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

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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
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 2, 2015

Status Verified

May 1, 2015

Enrollment Period

2.3 years

First QC Date

August 15, 2014

Last Update Submit

June 1, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Adult ADHD Self-Report Scale (ASRS-v1.1)

    The Symptom Checklist is an instrument consisting of the eighteen Diagnostic and Statistical Manual criteria (DSM-IV). Six of the eighteen questions were found to be the most predictive of symptoms consistent with ADHD. These six questions are the basis for the ASRS v1.1. The measure is a number score. The ASRS-v1.1 will be administered to all participants before and 1 year after the intervention.

    Follow-up will be on the average 1 year after intervention

Secondary Outcomes (1)

  • The 12-item General Health Questionnaire (GHQ-12)

    Follow-up will be on the average 1 year after intervention

Other Outcomes (1)

  • Youth education attrition

    December 2016

Study Arms (2)

Control

NO INTERVENTION

Service as usual

Intervention group

EXPERIMENTAL

Participants are offered access to the web based resilience program and are invited to join a short introduction course.

Behavioral: The Resilience Program

Interventions

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

Intervention group

Eligibility Criteria

Age18 Years - 27 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • A random sample with 8.000 patients registered in the Danish National Patient Register:
  • Age 18-27
  • ADHD diagnosis

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

Location

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Poul L Bak

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2014

First Posted

August 19, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

June 2, 2015

Record last verified: 2015-05

Locations