Active — Not RecruitingNot Applicable

Executive Control Training for Adolescents With ADHD: A Randomized Controlled Effectiveness Trial

Norway120 participantsStarted 2023-09-15

Plain-language summary

The goal of this clinical trial is to evaluate an evidence-based, non-pharmacological treatment alternative: Goal Management Training (GMT) for adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). The main questions we aim to answer are: 1. Is GMT more effective than Treatment as Usual (TAU) in improving executive functioning in adolescents with ADHD? 2. Is GMT more effective than TAU in improving emotional health and social functioning in adolescents with ADHD? 3. Which clinical or cognitive characteristics are associated with treatment response? 4. Do medication, age, gender, and functional status at intake influence treatment response and long-term outcomes? 5. Are genetic (e.g. polygenic risk scores) and brain imaging data (e.g. estimates of brain maturation based on structural MRI or resting-state functional magnetic resonance imaging (fMRI) brain connectivity) relevant clinical predictors for treatment response and long-term outcomes?

Who can participate

Age range

12 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Adolescents with a diagnosis of ADHD (ICD-10, DSM-5).
. Aged 12-18 years. We will include irrespective of concurrent or previous pharmacological treatment.

Exclusion criteria

. Severe depression, suicidality, psychosis, bipolar disorder without stable medication and current substance abuse
. Organic brain injury or verified neurological disease (3) cognitive or medical impairments that have affected or are affecting the capacity to attend regular school.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Parent-Reported Behavior Rating Inventory of Executive Function - Second Edition (BRIEF-2).

Timeframe: Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, after 12 months, and after 24 months).

Trial details

NCT IDNCT05874791

SponsorSykehuset Innlandet HF

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-30

View on ClinicalTrials.gov More Attention Deficit Hyperactivity Disorder trials