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

NCT05874791 | Active Not Recruiting

• 6 other identifiers: 150687 and 150688420217150688150687102610213103876101
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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. 1.Is GMT more effective than Treatment as Usual (TAU) in improving executive functioning in adolescents with ADHD?
2. 2.Is GMT more effective than TAU in improving emotional health and social functioning in adolescents with ADHD?
3. 3.Which clinical or cognitive characteristics are associated with treatment response?
4. 4.Do medication, age, gender, and functional status at intake influence treatment response and long-term outcomes?
5. 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?

Conditions

Attention Deficit Hyperactivity Disorder; Executive Dysfunction

Keywords

adolescents; Goal Management Training

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, after 12 months, and after 24 months).

Secondary Outcomes (15)

• Change in Self-Reported Behavior Rating Inventory of Executive Function - Second Edition (BRIEF-2).

  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).

  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).

  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).

  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).

  Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).

Study Arms (2)

Goal management training

EXPERIMENTAL

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

Behavioral: Goal Management training

Treatment as Usual

NO INTERVENTION

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

Interventions

Goal Management training BEHAVIORAL

metacognitive group intervention

Goal management training

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sykehuset Innlandet HF: lead
• University of Oslo: collaborator
• Lovisenberg Diakonale Hospital: collaborator
• Oslo University Hospital: collaborator

Study Sites (2)

Innlandet hospital trust

Brumunddal, Brumunddal, 2380, Norway

Location

Lovisenberg Diakonale Hospital

Oslo, Oslo County, 0440, Norway

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Merete G Øie, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: May 25, 2023
• Study Start: September 15, 2023
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

NO (2)