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Resilience for Young People With ADHD - a Randomized Controlled Trial of a Brief Intervention Program.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02220140
Recruitment Status : Unknown
Verified May 2015 by University of Aarhus.
Recruitment status was:  Active, not recruiting
First Posted : August 19, 2014
Last Update Posted : June 2, 2015
Sponsor:
Collaborator:
TRYG Foundation
Information provided by (Responsible Party):
University of Aarhus

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'.

Condition or disease Intervention/treatment Phase
ADHD Behavioral: The Resilience Program Not Applicable

Detailed Description:
The complete CONSORT trial protocol is available at http://myresilience.org/ at the subsite 'about us'.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Resilience for Young People With Attention Deficit Hyperactivity Disorder (ADHD) - a Randomized Controlled Trial of a Brief Intervention Program.
Study Start Date : August 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Service as usual
Experimental: Intervention group
Participants are offered access to the web based resilience program and are invited to join a short introduction course.
Behavioral: The Resilience Program
See the CONSORT trial protocol at http://myresilience.org/ at the subsite 'about us'.




Primary Outcome Measures :
  1. Adult ADHD Self-Report Scale (ASRS-v1.1) [ Time Frame: Follow-up will be on the average 1 year after intervention ]

    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.



Secondary Outcome Measures :
  1. The 12-item General Health Questionnaire (GHQ-12) [ Time Frame: Follow-up will be on the average 1 year after intervention ]

    The GHQ-12 is a widely used standard Health Questionnaire. The GHQ-12 will be administered to all participants before and 1 year after the intervention.

    The measure is a number score.



Other Outcome Measures:
  1. Youth education attrition [ Time Frame: December 2016 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 27 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A random sample with 8.000 patients registered in the Danish National Patient Register:

  • Age 18-27
  • ADHD diagnosis

Exclusion Criteria:

• Request for legal protection against contacts from researchers.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220140


Locations
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Denmark
Aarhus University
Aarhus, Denmark
Sponsors and Collaborators
University of Aarhus
TRYG Foundation
Investigators
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Principal Investigator: Poul L Bak University of Aarhus
Additional Information:
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02220140    
Other Study ID Numbers: DK-res-adhd
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: June 2, 2015
Last Verified: May 2015