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

Sykehuset Innlandet HF

Status: Enrolling

Conditions: Attention Deficit Hyperactivity Disorder; Executive Dysfunction

Treatments: Behavioral: Goal Management training

Study type: Interventional

Funder types: Other

Identifiers

NCT05874791

150688 (Other Identifier)

150687 (Other Identifier)

150687 and 150688

103876101 (Other Identifier)

420217 (Other Identifier)

102610213 (Other Identifier)

Details and patient eligibility

About

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?

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Goal management training

Experimental group

Description:

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

Treatment:

Behavioral: Goal Management training

Treatment as Usual

No Intervention group

Description:

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