Clinical trial NCT05874791: Executive Control Training for Adolescents With ADHD: A Randomized Controlled Effectiveness Trial
Official title: Executive Control Training for Adolescents With ADHD: A Randomized Controlled
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Executive Dysfunction
Keywords: adolescents
Goal Management Training
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Lovisenberg Diakonale Hospital
name: Oslo University Hospital
First posted: 2023-05-25
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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?

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: 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).
Secondary outcomes:
measure: Change in Self-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).
measure: Change in Teacher-Reported Behavior Rating Inventory of Executive Function - Second Edition (BRIEF-2).
timeFrame: Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).
measure: Change in Attention Span task from Cognitive Assessment at Bedside for IPad (CABPad).
timeFrame: Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).
measure: Change in Working Memory task from Cognitive Assessment at Bedside for IPad (CABPad).
timeFrame: Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).
measure: Change in Arrow Stroop task from Cognitive Assessment at Bedside for IPad (CABPad).
timeFrame: Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).
measure: Change in Symbol Digit Coding (Mental and Visuo-Motor Speed) task from Cognitive Assessment at Bedside for IPad (CABPad).
timeFrame: Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).
measure: Change in Parent-Reported Achenbach System of Empirically Based Assessment (ASEBA).
timeFrame: Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, and after 24 months).
measure: Change in Self-Reported Achenbach System of Empirically Based Assessment (ASEBA).
timeFrame: Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, and after 24 months).
measure: Change in Parent-Reported Weiss Functional Impairment Rating Scale (WFIRS-P).
timeFrame: Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, and after 24 months).
measure: Change in Parent-Reported ADHD Rating scale (ADHD-RS-IV Home).
timeFrame: Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, and after 24 months).
measure: Change in Teacher-Reported ADHD Rating scale (ADHD-RS-IV School).
timeFrame: Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).
measure: Change in Parent-Rated Pediatric Quality of Life Inventory (PedsQL).
timeFrame: Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, and after 24 months).
measure: Change in Self-Rated Pediatric Quality of Life Inventory (PedsQL).
timeFrame: Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, and after 24 months).
measure: Change in Goal Attainment Scaling (GAS).
timeFrame: Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).
measure: Change in Children's Global Assessment Scale (CGAS).
timeFrame: Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).
Other outcomes:
Locations:
city: Brumunddal
country: Norway
facility: Innlandet hospital trust
city: Oslo
country: Norway
facility: Lovisenberg Diakonale Hospital
Study officials:
affiliation: Department of Psychology, Faculty of Social Sciences, University of Oslo
name: Merete G Øie, PhD
role: PRINCIPAL_INVESTIGATOR
References: