Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05874791
Status:
RECRUITING
Last Update Posted:
2023-09-29
First Post:
2023-04-14
Brief Title:
Executive Control Training for Adolescents With ADHD A Randomized Controlled Effectiveness Trial
Sponsor:
Sykehuset Innlandet HF
Organization:
Sykehuset Innlandet HF
Study Overview
Official Title:
Executive Control Training for Adolescents With ADHD A Randomized Controlled
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADHD Effect
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-DeficitHyperactivity 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 eg polygenic risk scores and brain imaging data eg 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
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 eg polygenic risk scores and brain imaging data eg 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 eg polygenic scores and brain imaging data collected at baseline eg 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
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 eg polygenic scores and brain imaging data collected at baseline eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 103876101 | OTHER | Oslo University Hospital NEVSOM | None |
| 420217 | OTHER | None | None |
| 150688 | OTHER | None | None |
| 150687 | OTHER | None | None |
| 102610213 | OTHER | None | None |