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

June 1, 2015 updated by: University of Aarhus

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

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'.

Study Overview

Status

Unknown

Conditions

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)

8000

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

  • Denmark
      • Aarhus, Denmark
        • 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

18 years to 27 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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'.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Follow-up will be on the average 1 year after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Follow-up will be on the average 1 year after intervention

Other Outcome Measures

Outcome Measure
Time Frame
Youth education attrition
Time Frame: December 2016
December 2016

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

TRYG Foundation

Investigators

  • Principal Investigator: Poul L Bak, 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.

Helpful Links

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)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

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

May 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • DK-res-adhd

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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