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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title: Executive Control Training for Adolescents With ADHD: A Randomized Controlled

Status Recruiting

Clinical 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. 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?

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Executive Dysfunction

• NCT number: NCT05874791
• Study type: Interventional
• Source: Sykehuset Innlandet HF
• Contact: Merete G Øie, PhD
• Phone: 0047 40889007
• Email: m.g.oie@psykologi.uio.no
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2023
• Completion date: December 30, 2028