The Efficacy of Goal Focused, Non-Pharmacological Treatment for Persons With ADHD/ADD. (NCT04638283) | Clinical Trial Compass
CompletedNot Applicable
The Efficacy of Goal Focused, Non-Pharmacological Treatment for Persons With ADHD/ADD.
Norway80 participantsStarted 2019-08-15
Plain-language 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 ADHD/ADD 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Diagnosis of Hyperkinetic disorder, ADHD or ADD. Both patients recently diagnosed at DPS and patients previously diagnosed can be included.
. Subjective complaints about executive problems affecting everyday life, operationalized as a score of 60 or above on BRIEF-A or as reported in the inclusion interview.
. Motivation for working with the executive problems in order to increase coping in everyday life.
. Adequate language skills to participate in group discussions without any need for an interpreter.
Exclusion criteria
. CNS injury or disease other than hyperkinetic disorder, ADHD or ADD.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Behavior Rating Inventory of Executive Function for Adults (BRIEF-A)
Timeframe: Change from baseline BRIEF-A at 8 months.
. Psychopathology that would negatively interfere with participation in the intervention, e.g. ongoing psychosis, present suicidal risk to severe to be treated in an out-patient setting or personality disorders considered to severe to be treated in a group-based out-patient setting.