Attention Deficit Hyperactivity DisorderADHD EffectNCT05874791
Executive Control Training for Adolescents With ADHD: A Randomized Controlled Effectiveness Trial
A study testing Goal Management training in people with Attention Deficit Hyperactivity Disorder and Executive Dysfunction, run by Sykehuset Innlandet HF at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Executive Dysfunction
- What is being tested?
- Goal Management training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesNorway
- Study dates
- 15 Sep 2023to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents with a diagnosis of ADHD (ICD-10, DSM-5).
- Aged 12-18 years. We will include irrespective of concurrent or previous pharmacological treatment.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Innlandet hospital trust
Brumunddal, Brumunddal, 2380
Lovisenberg Diakonale Hospital
Oslo, Oslo, 0440
About this study
Official title: Executive Control Training for Adolescents With ADHD: A Randomized Controlled
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:
- Is GMT more effective than Treatment as Usual (TAU) in improving executive functioning in adolescents with ADHD?
- Is GMT more effective than TAU in improving emotional health and social functioning in adolescents with ADHD?
- Which clinical or cognitive characteristics are associated with treatment response?
- Do medication, age, gender, and functional status at intake influence treatment response and long-term outcomes?
- 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?
Read the detailed description
ADHD is characterized by impaired executive functions (EFs). EFs are brain functions that allow us to direct our attention, retain relevant information, and ignore distractions in order to achieve our daily goals. Impairments in EF are associated with poorer academic achievement and vocational functioning, psychopathology symptoms, emotional and social problems, as well as lower quality of life in children and adolescents with ADHD. Furthermore, pharmacological treatment has not been shown to significantly improve EF difficulties, and there is still a considerable knowledge gap regarding the efficacy of non-pharmacological treatment for ADHD. Additionally, the research is often limited by short follow-up periods and few outcome measures.
We propose a randomized controlled trial, comparing a seven-week non-pharmacological cognitive remediation program designed to improve EFs; Goal Management Training (GMT), to treatment-as-usual (TAU) for 120 adolescents with ADHD. The primary outcome is executive function behaviors in the school and home environments (Behavior Rating Inventory of Executive Function 2, parent report). Secondary outcomes include neuropsychological tests, mental health, quality of life, and social deficit symptoms. Participants will be assessed at baseline, after 12 weeks, and 12- and 24 months post-treatment. In addition, we will collect biological samples and brain MRI data in a sub-sample, which will allow us to test whether genetic (e.g. polygenic scores) and brain imaging data collected at baseline (e.g. estimates of brain maturation based on structural MRI or resting-state fMRI brain connectivity) are relevant clinical predictors for treatment response and long-term outcomes. If sample size allows, these analyses will be purely exploratory, and the relevant measures will not be specified in this registration.
The expected main benefit of the described study is to provide evidence-based non-pharmacological treatment to a vulnerable group, potentially improving life-long function and adherence to education, work, and social life.
During the autumn of 2024, a qualitative interview will be conducted with a few participants who have completed GMT, and the co-therapists will participate in a focus group interview. The purpose is to complement the quantitative data from the main study with qualitative data on how GMT is experienced by participants and therapists. This sub-study has been approved by the ethics committee and data protection authorities.
- Being tested
- Goal Management training
- Keywords
- adolescents, Goal Management Training
- 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.
Goal Management trainingBehavioural
metacognitive group intervention
| Study group | Role | What they receive |
|---|---|---|
| Goal management training | Experimental | Cognitive rehabilitation:14 hours of GMT in groups of 4-6 participants, administered following a script with accompanying PowerPoint slides and participant workbooks, over the course of 7 weeks (one 2-hour session per week). In addition, the participants receive Treatment as Usual Receives: Behavioral: Goal Management training |
| Treatment as Usual | No intervention | Norway has established clinical guidelines for ADHD assessment and treatment in public health, emphasizing psychoeducation, parent management training, school counseling, and pharmacological treatment adapted to the needs of each patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Parent-Reported Behavior Rating Inventory of Executive Function - Second Edition (BRIEF-2).
Rating inventory assessing executive function in daily life. Higher scores indicate greater executive dysfunction. The total score ranges from 86 - 258.
Measured: Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, after 12 months, and after 24 months).
Secondary outcomes (15)
Change in Self-Reported Behavior Rating Inventory of Executive Function - Second Edition (BRIEF-2).
Rating inventory assessing executive function in daily life. Higher scores indicate greater executive dysfunction. The total score ranges from 80 - 240.
Measured: Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, after 12 months, and after 24 months).
Change in Teacher-Reported Behavior Rating Inventory of Executive Function - Second Edition (BRIEF-2).
Rating inventory assessing executive function in daily life. Higher scores indicate greater executive dysfunction. The total score ranges from 86 - 258.
Measured: Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).
Change in Attention Span task from Cognitive Assessment at Bedside for IPad (CABPad).
Performance-based Executive functioning tests: To assess simple attention span. The scoring is based on the number of objects remembered. More objects indicate higher attention span.
Measured: Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).
Change in Working Memory task from Cognitive Assessment at Bedside for IPad (CABPad).
Performance-based Executive functioning test: To assess working memory. The scoring is based on the number of objects remembered. More objects indicate a better working memory.
Measured: Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).
Change in Arrow Stroop task from Cognitive Assessment at Bedside for IPad (CABPad).
Performance-based Executive functioning test: To investigate executive control of attention, more specifically cognitive impulse control. Scoring is based on reaction time and the number of incorrect/correct responses.
Measured: Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).
Change in Symbol Digit Coding (Mental and Visuo-Motor Speed) task from Cognitive Assessment at Bedside for IPad (CABPad).
Performance-based Executive functioning test: To investigate mental and visuo-motor speed. Scoring is based on reaction time and the number of incorrect/correct responses.
Measured: Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).
Change in Parent-Reported Achenbach System of Empirically Based Assessment (ASEBA).
Assessment rating adaptive and maladaptive functioning. Higher scores indicate greater difficulty. The total score ranges from 0 - 224.
Measured: Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, and after 24 months).
Change in Self-Reported Achenbach System of Empirically Based Assessment (ASEBA).
Assessment rating adaptive and maladaptive functioning. Higher scores indicate greater difficulty. The total score ranges from 0 - 224.
Measured: Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, and after 24 months).
Change in Parent-Reported Weiss Functional Impairment Rating Scale (WFIRS-P).
Rating inventory that evaluates the extent to which an individual's ability to function is impaired. The 50-item scale uses a Likert scale, such that any item rating 2 or 3 is clinically impaired. The total score ranges from 0 - 150.
Measured: Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, and after 24 months).
Change in Parent-Reported ADHD Rating scale (ADHD-RS-IV Home).
Rating inventory that detects ADHD symptoms in children and adolescents reported by parents. The 18-item scale generates a total score between 0 - 54, where the higher score indicates greater difficulty.
Measured: Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, and after 24 months).
Change in Teacher-Reported ADHD Rating scale (ADHD-RS-IV School).
Rating inventory that detects ADHD symptoms in children and adolescents. The 18-item scale generates a total score between 0 - 54, where the higher score indicates greater difficulty.
Measured: Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).
Change in Parent-Rated Pediatric Quality of Life Inventory (PedsQL).
Measurement of health-related quality of life. The 23-item scale generates a total score between 0-100, where 100 points indicate optimal quality of life.
Measured: Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, and after 24 months).
Change in Self-Rated Pediatric Quality of Life Inventory (PedsQL).
Measurement of health-related quality of life.The 23-items scale generates a total score between 0-100, where 100 points indicate optimal quality of life.
Measured: Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, and after 24 months).
Change in Goal Attainment Scaling (GAS).
Method of rating performance based on a criterion-referenced scale with defined anchor points. If the patient achieves the expected level, this is scored at 0. If they achieve a better than expected outcome this is scored at: +1 (somewhat better), +2 (much better). If they achieve a worse than expected outcome this is scored at: -1 (somewhat worse), or -2 (much worse). The patient and the clinician decide this score together.
Measured: Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).
Change in Children's Global Assessment Scale (CGAS).
Measure of a child's or adolescent's psychosocial functioning on a scale from 1 (lowest functioning) to 100 (superior functioning in all areas). Rated by an independent observer.
Measured: Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start15 Sep 2023
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sykehuset Innlandet HF
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Lovisenberg Diakonale Hospital, Oslo University Hospital
- Responsible party
- Sponsor
- Investigators
- Merete G Øie, PhD, Principal investigator, Department of Psychology, Faculty of Social Sciences, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874791
- Sponsor's protocol ID
- 150687 and 150688
- Other IDs
- 420217, 150688, 150687, 102610213, 103876101
- Acronym
- ADHD Effect
- Status last verified
- May 2025
- First submitted
- 14 Apr 2023
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Executive Control Training for Adolescents With ADHD: A Randomized Controlled
- ClinicalTrials.gov ID
- NCT05874791
- Acronym / sponsor ID
- ADHD Effect / 150687 and 150688
- Keywords
- adolescents, Goal Management Training
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sykehuset Innlandet HFUniversity, hospital or other
- Collaborators
- University of Oslo, Lovisenberg Diakonale Hospital, Oslo University Hospital
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 25 May 2023 (actual)
- 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.
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:
- Is GMT more effective than Treatment as Usual (TAU) in improving executive functioning in adolescents with ADHD?
- Is GMT more effective than TAU in improving emotional health and social functioning in adolescents with ADHD?
- Which clinical or cognitive characteristics are associated with treatment response?
- Do medication, age, gender, and functional status at intake influence treatment response and long-term outcomes?
- 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?
Detailed description
ADHD is characterized by impaired executive functions (EFs). EFs are brain functions that allow us to direct our attention, retain relevant information, and ignore distractions in order to achieve our daily goals. Impairments in EF are associated with poorer academic achievement and vocational functioning, psychopathology symptoms, emotional and social problems, as well as lower quality of life in children and adolescents with ADHD. Furthermore, pharmacological treatment has not been shown to significantly improve EF difficulties, and there is still a considerable knowledge gap regarding the efficacy of non-pharmacological treatment for ADHD. Additionally, the research is often limited by short follow-up periods and few outcome measures.
We propose a randomized controlled trial, comparing a seven-week non-pharmacological cognitive remediation program designed to improve EFs; Goal Management Training (GMT), to treatment-as-usual (TAU) for 120 adolescents with ADHD. The primary outcome is executive function behaviors in the school and home environments (Behavior Rating Inventory of Executive Function 2, parent report). Secondary outcomes include neuropsychological tests, mental health, quality of life, and social deficit symptoms. Participants will be assessed at baseline, after 12 weeks, and 12- and 24 months post-treatment. In addition, we will collect biological samples and brain MRI data in a sub-sample, which will allow us to test whether genetic (e.g. polygenic scores) and brain imaging data collected at baseline (e.g. estimates of brain maturation based on structural MRI or resting-state fMRI brain connectivity) are relevant clinical predictors for treatment response and long-term outcomes. If sample size allows, these analyses will be purely exploratory, and the relevant measures will not be specified in this registration.
The expected main benefit of the described study is to provide evidence-based non-pharmacological treatment to a vulnerable group, potentially improving life-long function and adherence to education, work, and social life.
During the autumn of 2024, a qualitative interview will be conducted with a few participants who have completed GMT, and the co-therapists will participate in a focus group interview. The purpose is to complement the quantitative data from the main study with qualitative data on how GMT is experienced by participants and therapists. This sub-study has been approved by the ethics committee and data protection authorities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goal management training | Experimental | Behavioral: Goal Management trainingCognitive rehabilitation:14 hours of GMT in groups of 4-6 participants, administered following a script with accompanying PowerPoint slides and participant workbooks, over the course of 7 weeks (one 2-hour session per week). In addition, the participants receive Treatment as Usual |
| Treatment as Usual | No intervention | –Norway has established clinical guidelines for ADHD assessment and treatment in public health, emphasizing psychoeducation, parent management training, school counseling, and pharmacological treatment adapted to the needs of each patient |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Adolescents with a diagnosis of ADHD (ICD-10, DSM-5).
- Aged 12-18 years. We will include irrespective of concurrent or previous pharmacological treatment.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Goal Management trainingmetacognitive group intervention | Behavioural | Goal management training |
Primary outcome
Change in Parent-Reported Behavior Rating Inventory of Executive Function - Second Edition (BRIEF-2).
Time frame: Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, after 12 months, and after 24 months).
Rating inventory assessing executive function in daily life. Higher scores indicate greater executive dysfunction. The total score ranges from 86 - 258.
15 secondary outcomes
Change in Self-Reported Behavior Rating Inventory of Executive Function - Second Edition (BRIEF-2).
Time frame: Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, after 12 months, and after 24 months).
Change in Teacher-Reported Behavior Rating Inventory of Executive Function - Second Edition (BRIEF-2).
Time frame: Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).
Change in Attention Span task from Cognitive Assessment at Bedside for IPad (CABPad).
Time frame: Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).
Change in Working Memory task from Cognitive Assessment at Bedside for IPad (CABPad).
Time frame: Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).
Change in Arrow Stroop task from Cognitive Assessment at Bedside for IPad (CABPad).
Time frame: Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).
Change in Symbol Digit Coding (Mental and Visuo-Motor Speed) task from Cognitive Assessment at Bedside for IPad (CABPad).
Time frame: Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).
Change in Parent-Reported Achenbach System of Empirically Based Assessment (ASEBA).
Time frame: Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, and after 24 months).
Change in Self-Reported Achenbach System of Empirically Based Assessment (ASEBA).
Time frame: Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, and after 24 months).
Change in Parent-Reported Weiss Functional Impairment Rating Scale (WFIRS-P).
Time frame: Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, and after 24 months).
Change in Parent-Reported ADHD Rating scale (ADHD-RS-IV Home).
Time frame: Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, and after 24 months).
Change in Teacher-Reported ADHD Rating scale (ADHD-RS-IV School).
Time frame: Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).
Change in Parent-Rated Pediatric Quality of Life Inventory (PedsQL).
Time frame: Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, and after 24 months).
Change in Self-Rated Pediatric Quality of Life Inventory (PedsQL).
Time frame: Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, and after 24 months).
Change in Goal Attainment Scaling (GAS).
Time frame: Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).
Change in Children's Global Assessment Scale (CGAS).
Time frame: Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: Yes
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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.
Merete G Øie, PhD principal investigator
Department of Psychology, Faculty of Social Sciences, University of Oslo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal Management training in people with Attention Deficit Hyperactivity Disorder and Executive Dysfunction, run by Sykehuset Innlandet HF at 2 sites in Norway.
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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Parent-Reported Behavior Rating Inventory of Executive Function - Second Edition (BRIEF-2). (time frame: Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, after 12 months, and after 24 months).). 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 28 May 2025.