ADHDNCT02220140
Resilience for Young People With ADHD - a Randomized Controlled Trial of a Brief Intervention Program.
A study testing The Resilience Program in people with ADHD, run by University of Aarhus at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 18 to 27 years
- Conditions the study is for
- ADHD
- What is being tested?
- The Resilience Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,000 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 27 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A random sample with 8.000 patients registered in the Danish National Patient Register:
- Age 18-27
- ADHD diagnosis
Who cannot join
- Request for legal protection against contacts from researchers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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'.
Read the detailed description
The complete CONSORT trial protocol is available at http://myresilience.org/ at the subsite 'about us'.
- Conditions
- ADHD
- Being tested
- The Resilience Program
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Resilience ProgramBehavioural
See the CONSORT trial protocol at http://myresilience.org/ at the subsite 'about us'.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: The Resilience Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Follow-up will be on the average 1 year after intervention
Secondary outcomes (1)
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.
Measured: Follow-up will be on the average 1 year after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- TRYG Foundation
- Responsible party
- Sponsor
- Investigators
- Poul L Bak, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220140
- Sponsor's protocol ID
- DK-res-adhd
- Status last verified
- May 2015
- First submitted
- 15 Aug 2014
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resilience for Young People With Attention Deficit Hyperactivity Disorder (ADHD) - a Randomized Controlled Trial of a Brief Intervention Program.
- ClinicalTrials.gov ID
- NCT02220140
- Acronym / sponsor ID
- DK-res-adhd
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- TRYG Foundation
- Study start
- Aug 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 19 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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'.
Detailed description
The complete CONSORT trial protocol is available at http://myresilience.org/ at the subsite 'about us'.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Service as usual |
| Intervention group | Experimental | Behavioral: The Resilience ProgramParticipants are offered access to the web based resilience program and are invited to join a short introduction course. |
Who may qualify
- Ages
- 18 to 27 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-27
- ADHD diagnosis
Key exclusion criteria (1 listed)
- Request for legal protection against contacts from researchers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Resilience ProgramSee the CONSORT trial protocol at http://myresilience.org/ at the subsite 'about us'. | Behavioural | Intervention group |
Primary outcome
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.
1 secondary outcome
The 12-item General Health Questionnaire (GHQ-12)
Time frame: Follow-up will be on the average 1 year after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
- See the CONSORT trial protocol at the subsite 'about us'Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Poul L Bak principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Resilience Program in people with ADHD, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adult ADHD Self-Report Scale (ASRS-v1.1) (time frame: Follow-up will be on the average 1 year after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2015; AzTrials last refreshed its copy on 2 Nov 2026.