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

NCT ID: NCT05874791

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2028-12-30

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.

Conditions

Attention Deficit Hyperactivity Disorder; Executive Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Goal management training

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

Group Type: EXPERIMENTAL

Goal Management training

Intervention Type: BEHAVIORAL

metacognitive group intervention

Treatment as Usual

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Goal Management training

metacognitive group intervention

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oslo

OTHER

Sponsor Role: collaborator

Lovisenberg Diakonale Hospital

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: collaborator

Sykehuset Innlandet HF

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Merete G Øie, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychology, Faculty of Social Sciences, University of Oslo

Locations

Innlandet hospital trust

Brumunddal, Brumunddal, Norway

Lovisenberg Diakonale Hospital

Oslo, Oslo County, Norway

Countries

Norway

Other Identifiers

420217

Identifier Type: OTHER

Identifier Source: secondary_id

150688

Identifier Type: OTHER

Identifier Source: secondary_id

150687

Identifier Type: OTHER

Identifier Source: secondary_id

102610213

Identifier Type: OTHER

Identifier Source: secondary_id

103876101

Identifier Type: OTHER

Identifier Source: secondary_id

150687 and 150688

Identifier Type: -

Identifier Source: org_study_id