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?
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
metacognitive group intervention
Innlandet hospital trust
Brumunddal, Brumunddal, Norway
Lovisenberg Diakonale Hospital
Oslo, Oslo County, Norway
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.
Time frame: Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, after 12 months, and after 24 months).
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.
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).
Rating inventory assessing executive function in daily life. Higher scores indicate greater executive dysfunction. The total score ranges from 86 - 258.
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).
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.
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).
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.
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).
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.
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).
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.
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).
Assessment rating adaptive and maladaptive functioning. Higher scores indicate greater difficulty. The total score ranges from 0 - 224.
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).
Assessment rating adaptive and maladaptive functioning. Higher scores indicate greater difficulty. The total score ranges from 0 - 224.
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).
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.
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).
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.
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).
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.
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).
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.
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).
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.
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).
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.
Time frame: 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.
Time frame: Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).
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