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

Executive Control Training for Adolescents With ADHD: A Randomized Controlled

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?

Study Overview

• Status: Recruiting
• Conditions: Attention Deficit Hyperactivity Disorder; Executive Dysfunction
• Intervention / Treatment: Behavioral: Goal Management training

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Merete G Øie, PhD; Phone Number: 0047 40889007; Email: m.g.oie@psykologi.uio.no
• Study Contact Backup: Name: Ingvild Haugen, PhD; Phone Number: 0047 48212595; Email: ingvild.haugen@sykehuset-innlandet.no

Study Locations

• Norway
  • Brumunddal, Norway, 2380
    • Recruiting
    • Innlandet Hospital Trust
    • Contact: Ingvild Haugen, Phd
    • Principal Investigator: Merete G Øie, PhD
  • Oslo, Norway, 0440
    • Recruiting
    • Lovisenberg Diakonale Hospital
    • Principal Investigator: Merete G Øie, PhD
    • Contact: Agnete Dyresen, cand.psychol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: Goal Management training; metacognitive group intervention
No 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Self-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 80 - 240.	Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, after 12 months, and after 24 months).
Change in Attention Span task from Cognitive Assessment at Bedside for IPad (CABPad).	Performance-based Executive functioning tests: To assess simple attention span. The scoring is based on the number of objects remembered. More objects indicate higher attention span.	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).	Performance-based Executive functioning test: To assess working memory. The scoring is based on the number of objects remembered. More objects indicate a better working memory.	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).	Performance-based Executive functioning test: To investigate executive control of attention, more specifically cognitive impulse control. Scoring is based on reaction time and the number of incorrect/correct responses.	Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).
Change in Symbol Digit Coding (Mental and Visuo-Motor Speed) task from Cognitive Assessment at Bedside for IPad (CABPad).	Performance-based Executive functioning test: To investigate mental and visuo-motor speed. Scoring is based on reaction time and the number of incorrect/correct responses.	Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).
Change in Parent-Reported Achenbach System of Empirically Based Assessment (ASEBA).	Assessment rating adaptive and maladaptive functioning. Higher scores indicate greater difficulty. The total score ranges from 0 - 224.	Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, and after 24 months).
Change in Self-Reported Achenbach System of Empirically Based Assessment (ASEBA).	Assessment rating adaptive and maladaptive functioning. Higher scores indicate greater difficulty. The total score ranges from 0 - 224.	Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, and after 24 months).
Change in Parent-Reported Weiss Functional Impairment Rating Scale (WFIRS-P).	Rating inventory that evaluates the extent to which an individual's ability to function is impaired. The 50-item scale uses a Likert scale, such that any item rating 2 or 3 is clinically impaired. The total score ranges from 0 - 150.	Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, and after 24 months).
Change in Parent-Reported ADHD Rating scale (ADHD-RS-IV Home).	Rating inventory that detects ADHD symptoms in children and adolescents reported by parents. The 18-item scale generates a total score between 0 - 54, where the higher score indicates greater difficulty.	Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, and after 24 months).
Change in Parent-Rated Pediatric Quality of Life Inventory (PedsQL).	Measurement of health-related quality of life. The 23-item scale generates a total score between 0-100, where 100 points indicate optimal quality of life.	Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, and after 24 months).
Change in Self-Rated Pediatric Quality of Life Inventory (PedsQL).	Measurement of health-related quality of life.The 23-items scale generates a total score between 0-100, where 100 points indicate optimal quality of life.	Change from Baseline up to 24 months (Assessed at Baseline, after 12 weeks, and after 24 months).
Change in Goal Attainment Scaling (GAS).	Method of rating performance based on a criterion-referenced scale with defined anchor points. If the patient achieves the expected level, this is scored at 0. If they achieve a better than expected outcome this is scored at: +1 (somewhat better), +2 (much better). If they achieve a worse than expected outcome this is scored at: -1 (somewhat worse), or -2 (much worse). The patient and the clinician decide this score together.	Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).
Change in Children's Global Assessment Scale (CGAS).	Measure of a child's or adolescent's psychosocial functioning on a scale from 1 (lowest functioning) to 100 (superior functioning in all areas). Rated by an independent observer.	Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).
Change in Teacher-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 12 weeks (Assessed at Baseline, and after 12 weeks).
Change in Teacher-Reported ADHD Rating scale (ADHD-RS-IV School).	Rating inventory that detects ADHD symptoms in children and adolescents. The 18-item scale generates a total score between 0 - 54, where the higher score indicates greater difficulty.	Change from Baseline up to 12 weeks (Assessed at Baseline, and after 12 weeks).

Collaborators and Investigators

• Sponsor: Sykehuset Innlandet HF
• Collaborators: University of Oslo; Oslo University Hospital; Lovisenberg Diakonale Hospital
• Investigators: Principal Investigator: Merete G Øie, PhD, Department of Psychology, Faculty of Social Sciences, University of Oslo

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: April 14, 2023
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: adolescents; Goal Management Training
• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: 150687 and 150688; 420217 (Other Identifier: REK); 150688 (Other Identifier: Innlandet Hospital Trust (PhD)); 150687 (Other Identifier: Innlandet Hospital Trust (Post doc)); 102610213 (Other Identifier: Department of Psychology, University of Oslo (PhD)); 103876101 (Other Identifier: Oslo University Hospital, NEVSOM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No