Ignite Creation Date:
2024-05-06 @ 3:26 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04638283
Status:
COMPLETED
Last Update Posted:
2022-02-18
First Post:
2020-10-15
Brief Title:
The Efficacy of Goal Focused Non-Pharmacological Treatment for Persons With ADHDADD
Sponsor:
University Hospital Akershus
Organization:
University Hospital Akershus
Study Overview
Official Title:
The Efficacy of Goal Focused Non-Pharmacological Treatment for Persons With ADHDADD A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-02
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:
None
Brief Summary:
The study aims to improve the understanding of non-pharmacological treatments of ADHD with a particular emphasis on coping with executive problems Executive functions can be defined as those abilities necessary to formulate goals carry them out effectively and enabling a person to engage successfully in independent purposive self-serving behavior
The intervention consists of
1 Eight psycho-educative group sessions focusing on Goal Management Training GMT a method aiming to enhance goal directed behavior developed by Levine and colleagues in 2011
2 Four individual sessions where the participants are guided through the process of formulation individual goals for improving functioning in everyday life The method used for goal setting is Goal Attainment Scaling GAS developed by Kiresuk and Sherman in 1968
3 Bi-weekly telephone follow up the first three months preceding the group sessions focusing on the attainment of GAS-goals
Adult participants with ADHDADD are recruited from the outpatient psychiatric health care clinic DPS Nedre Romerike at Akershus University Hospital and are randomized into either 1 an intervention-group receiving the intervention described above or 2 a control-group receiving treatment as usual
It is hypothesized that the intervention will improve executive functioning reported ADHD-symptoms and psychological well-being It is also hypothesized that the participants sucessfully will formulate and implement GAS-goals and that goal attainment will sustain throughout the follow-up phase
The intervention consists of
1 Eight psycho-educative group sessions focusing on Goal Management Training GMT a method aiming to enhance goal directed behavior developed by Levine and colleagues in 2011
2 Four individual sessions where the participants are guided through the process of formulation individual goals for improving functioning in everyday life The method used for goal setting is Goal Attainment Scaling GAS developed by Kiresuk and Sherman in 1968
3 Bi-weekly telephone follow up the first three months preceding the group sessions focusing on the attainment of GAS-goals
Adult participants with ADHDADD are recruited from the outpatient psychiatric health care clinic DPS Nedre Romerike at Akershus University Hospital and are randomized into either 1 an intervention-group receiving the intervention described above or 2 a control-group receiving treatment as usual
It is hypothesized that the intervention will improve executive functioning reported ADHD-symptoms and psychological well-being It is also hypothesized that the participants sucessfully will formulate and implement GAS-goals and that goal attainment will sustain throughout the follow-up phase
Detailed Description:
Given the 1 high prevalence and possible detrimental consequences of ADHD 2 limitations related to pharmacological ADHD-treatments 3 scarce evidence of the effects of long term use of pharmacological treatment and 4 limitations related to the present evidence base for the effects of non-pharmacological treatments research on the effects of non-pharmacological ADHD treatment is highly required
Goal Management Training GMT Levine et al 2011 is a theory-driven intervention relying on metacognitive strategies to reengage endogenous attention processes in addition to teaching problem-solving techniques to improve goal-directed capacity GMT draws upon theories regarding sustained attention mindfulness and goal processing The aim is to increase awareness of errors and strategies while facing complex everyday challenges The patient learns to stop ongoing behavior define goal hierarchies and to adjust and monitor goals Generalization to everyday-life is heavily emphasized
In previous studies GMT has been shown to improve goal directed behaviour including generalization effects to daily life and psychological well-being in various neurological conditions eg acquired brain injury and spina bifida Hypher et al 2019 Stubberud et al 2014 Tornås et al 2016 and normal ageing Levine et al 2007 The evidence of GMT in the adult ADHD populations is scarce
To the investigators knowledge this is the first trial combining group based GMT and individual goal setting within the frame of a psycho-educative cognitive rehabilitation intervention in order to help adults with ADHD cope with executive problems in everyday life
Research questions and hypotheses
1 Does the intervention combining GMT psychoeducation and implementation of GAS goals result in improvements in executive problems for adults with ADHD when compared to treatment as usual TAU Hypothesis 1 Post intervention changes in executive functions will be reflected in improved scores on a measure pertaining to daily life executive function BRIEF-A at five- and eights months follow up
2 Does the intervention result in improvements of reported ADHD symptoms when compared to TAU Hypothesis 2 Post intervention changes in ADHD-symptoms will be reflected in improved scores on a measure pertaining to ADHD-symptoms ASRS-v11 at five and eight months follow-up
3 Does participation in the intervention improve psychological well-being when compared to TAU Hypothesis 3 Post intervention changes in psychological well-being will be reflected in improved scores on a measure pertaining to psychological well-being HSCL-25 at five and eight months follow-up
4 Will the participants succeed in attaining individual GAS goals for coping with executive problems Hypothesis 4 The participants will successfully formulate and implement GAS-goals for coping with executive problems in everyday life Goal attainment will sustain throughout the three-month long implementation phase and sustain until the eight month follow up
Goal Management Training GMT Levine et al 2011 is a theory-driven intervention relying on metacognitive strategies to reengage endogenous attention processes in addition to teaching problem-solving techniques to improve goal-directed capacity GMT draws upon theories regarding sustained attention mindfulness and goal processing The aim is to increase awareness of errors and strategies while facing complex everyday challenges The patient learns to stop ongoing behavior define goal hierarchies and to adjust and monitor goals Generalization to everyday-life is heavily emphasized
In previous studies GMT has been shown to improve goal directed behaviour including generalization effects to daily life and psychological well-being in various neurological conditions eg acquired brain injury and spina bifida Hypher et al 2019 Stubberud et al 2014 Tornås et al 2016 and normal ageing Levine et al 2007 The evidence of GMT in the adult ADHD populations is scarce
To the investigators knowledge this is the first trial combining group based GMT and individual goal setting within the frame of a psycho-educative cognitive rehabilitation intervention in order to help adults with ADHD cope with executive problems in everyday life
Research questions and hypotheses
1 Does the intervention combining GMT psychoeducation and implementation of GAS goals result in improvements in executive problems for adults with ADHD when compared to treatment as usual TAU Hypothesis 1 Post intervention changes in executive functions will be reflected in improved scores on a measure pertaining to daily life executive function BRIEF-A at five- and eights months follow up
2 Does the intervention result in improvements of reported ADHD symptoms when compared to TAU Hypothesis 2 Post intervention changes in ADHD-symptoms will be reflected in improved scores on a measure pertaining to ADHD-symptoms ASRS-v11 at five and eight months follow-up
3 Does participation in the intervention improve psychological well-being when compared to TAU Hypothesis 3 Post intervention changes in psychological well-being will be reflected in improved scores on a measure pertaining to psychological well-being HSCL-25 at five and eight months follow-up
4 Will the participants succeed in attaining individual GAS goals for coping with executive problems Hypothesis 4 The participants will successfully formulate and implement GAS-goals for coping with executive problems in everyday life Goal attainment will sustain throughout the three-month long implementation phase and sustain until the eight month follow up
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