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

ADHD Clinical Trial

Official title:

Resilience for Young People With Attention Deficit Hyperactivity Disorder (ADHD) - a Randomized Controlled Trial of a Brief Intervention Program.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02220140
• Other study ID #: DK-res-adhd
• Status: Active, not recruiting
• Phase: N/A
• First received: August 15, 2014
• Last updated: June 1, 2015
• Start date: August 2014
• Est. completion date: December 2016

Study information

• Verified date: May 2015
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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'.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8000
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 27 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

Behavioral:
• The Resilience Program
See the CONSORT trial protocol at http://myresilience.org/ at the subsite 'about us'.

Locations

Country	Name	City	State
Denmark	Aarhus University	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	TRYG Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Youth education attrition		December 2016	No
Primary	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	No
Secondary	The 12-item General Health Questionnaire (GHQ-12)	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.	Follow-up will be on the average 1 year after intervention	No

External Links

•   See the CONSORT trial protocol at the subsite 'about us'