Attention-Deficit Hyperactivity Disorder, Unspecified TypeNCT04638283
The Efficacy of Goal Focused, Non-Pharmacological Treatment for Persons With ADHD/ADD.
A study testing Goal Attainment Scaling in people with Attention-Deficit Hyperactivity Disorder, Unspecified Type, run by University Hospital, Akershus at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Attention-Deficit Hyperactivity Disorder, Unspecified Type
- What is being tested?
- Goal Attainment Scaling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- 15 Aug 2019to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- CNS injury or disease other than hyperkinetic disorder, ADHD or ADD.
- Ongoing substance-abuse.
- 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.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Akershus University Hospital, DPS Nedre Romerike, Postboks 1000
Loerenskog, 1478
About this study
Official title: The Efficacy of Goal Focused, Non-Pharmacological Treatment for Persons With ADHD/ADD. A Randomized Controlled Trial.
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:
Read more
- 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.
- 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.
- 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.
Read the 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, e.g. 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
- 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.
- 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-v1.1) at five and eight months follow-up.
- 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.
- 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.
- Being tested
- Goal Attainment Scaling
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal Attainment ScalingBehavioural
Individual goals will be formulated and measured by Goal Attainment Scaling (GAS). GAS provides a method for quantifying the attainment of individualized goals, typically set in cognitive rehabilitation. Different levels of outcomes for each goal are operationalized in a five-point scale and given a numeric value. For each individual goal, minus two refers to the goal attainment much less than expected, minus one refers to a little less than expected, zero refers to expected outcome, plus one refers to a little bit better than expected and plus two refers to goal attainment much better than expected. The participants can establish as many goals as desired. Outcomes can be summed within different patient goals, as well as across patients to assess overall outcome of treatment outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Interventioh group | Experimental | The intervention consists of
1. Eight group sessions of two hours duration, focusing on GMT and ADHD. The Group consists of six participants and is directed by one neuropsychologist and one psychologist.
2. Four individual sessions with the neuropsychologist/psychologist directing the Group where the participant is guided through the process of formulating GAS-goals.
3. Bi-weekly Telephone follow up focusing on GAS-goal attainment the thre first months following the Group session phase. Receives: Behavioral: Goal Attainment Scaling |
| Control Group | No intervention | Participants in the Control Group receive TAU. Participation in the study does not influence decisions regarding pharmacological interventions in either of the groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior Rating Inventory of Executive Function for Adults (BRIEF-A)
BRIEF-A is a standardized informant- and self report Inventory measuring different aspects of executive functions (Rabin et al, 2006). Data (BRIEF-A self report form) is collected at baseline (T1), at 2 months (T2), at 5 months (T3) and finally at 8 months (T4). BRIEF-A informant report form is collected at baseline (T1) and at 8 months (T4).
Measured: Change from baseline BRIEF-A at 8 months.
Goal Attainment Scaling (GAS).
Individual goal attainment will be measured by GAS (Kiresuk and Sherman, 1968). Se description in the intervention-section. GAS-goals are formulated during the individual sessions and scored during biweekly telephone calls the three first months following the last group session.
Measured: Change from baseline GAS at 5 months.
Secondary outcomes (2)
Hopkins Symptom Checklist-25 (HSCL-25)
Psychological well-being will be measured by Hopkins Symptom Checklist-25 (Derogatis, 1947). HSCL-25 is a screening instrument measuring the presence and intensity of symptoms of anxiety and depression.Data collected at baseline (T1), at 2 months (T2), at 5 months (T3) and finally at 8 months.
Measured: Change from baseline HSCL-25 at 8 months.
The Adult ADHD Self Report Scale (ASRS-v.1.1)
ASRS-v1.1 (Kessler et al, 2005) us a questionnaire addressing symptoms of ADHD, developed in conjunction with the World Health Organization (Kessler et al, 2005). Data collected at baseline (T1), at 2 months (T2), at 5 months (T3) and finally at 8 months (T4)
Measured: Change from baseline ASRS-v.1.1 at 8 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start15 Aug 2019
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Attention-Deficit Hyperactivity Disorder, Unspecified TypeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participant is randomized by a lottery to participate either in the intervention group receiving the intervention described above or the controlgroup receiving TAU.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Kjersti Traeland Hanssen, University Hospital, Akershus
- Investigators
- Kjersti T Hanssen, PhD, Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638283
- Sponsor's protocol ID
- Goal Focused ADHD Treatment
- Status last verified
- Feb 2022
- First submitted
- 15 Oct 2020
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kessler RC, Adler L, Ames M, Demler O, Faraone S, Hiripi E, Howes MJ, Jin R, Secnik K, Spencer T, Ustun TB, Walters EE. The World Health Organization Adult ADHD Self-Report Scale (ASRS): a short screening scale for use in the general population. Psychol Med. 2005 Feb;35(2):245-56. doi: 10.1017/s0033291704002892.
PubMed 15841682Kiresuk TJ, Sherman RE. Goal attainment scaling: A general method for evaluating comprehensive community mental health programs. Community Ment Health J. 1968 Dec;4(6):443-53. doi: 10.1007/BF01530764.
PubMed 24185570Levine B, Schweizer TA, O'Connor C, Turner G, Gillingham S, Stuss DT, Manly T, Robertson IH. Rehabilitation of executive functioning in patients with frontal lobe brain damage with goal management training. Front Hum Neurosci. 2011 Feb 17;5:9. doi: 10.3389/fnhum.2011.00009. eCollection 2011.
PubMed 21369362Levine B, Stuss DT, Winocur G, Binns MA, Fahy L, Mandic M, Bridges K, Robertson IH. Cognitive rehabilitation in the elderly: effects on strategic behavior in relation to goal management. J Int Neuropsychol Soc. 2007 Jan;13(1):143-52. doi: 10.1017/S1355617707070178.
PubMed 17166313Rabin LA, Roth RM, Isquith PK, Wishart HA, Nutter-Upham KE, Pare N, Flashman LA, Saykin AJ. Self- and informant reports of executive function on the BRIEF-A in MCI and older adults with cognitive complaints. Arch Clin Neuropsychol. 2006 Oct;21(7):721-32. doi: 10.1016/j.acn.2006.08.004. Epub 2006 Sep 18.
PubMed 16979868Hypher RE, Brandt AE, Risnes K, Ro TB, Skovlund E, Andersson S, Finnanger TG, Stubberud J. Paediatric goal management training in patients with acquired brain injury: study protocol for a randomised controlled trial. BMJ Open. 2019 Aug 1;9(8):e029273. doi: 10.1136/bmjopen-2019-029273.
PubMed 31375619Stubberud J, Langenbahn D, Levine B, Stanghelle J, Schanke AK. Emotional health and coping in spina bifida after goal management training: a randomized controlled trial. Rehabil Psychol. 2015 Feb;60(1):1-16. doi: 10.1037/rep0000018. Epub 2014 Dec 15.
PubMed 25496433Tornas S, Lovstad M, Solbakk AK, Schanke AK, Stubberud J. Goal Management Training Combined With External Cuing as a Means to Improve Emotional Regulation, Psychological Functioning, and Quality of Life in Patients With Acquired Brain Injury: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2016 Nov;97(11):1841-1852.e3. doi: 10.1016/j.apmr.2016.06.014. Epub 2016 Jul 15.
PubMed 27424292Hanssen KT, Brevik EJ, Smastuen MC, Stubberud J. Improvement of anxiety in ADHD following goal-focused cognitive remediation: a randomized controlled trial. Front Psychol. 2023 Nov 17;14:1212502. doi: 10.3389/fpsyg.2023.1212502. eCollection 2023.
PubMed 38046113
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Goal Focused, Non-Pharmacological Treatment for Persons With ADHD/ADD. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04638283
- Acronym / sponsor ID
- Goal Focused ADHD Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
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, e.g. 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
- 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.
- 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-v1.1) at five and eight months follow-up.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participant is randomized by a lottery to participate either in the intervention group receiving the intervention described above or the controlgroup receiving TAU.
| Arm | Type | Receives |
|---|---|---|
| Interventioh group | Experimental | Behavioral: Goal Attainment ScalingThe intervention consists of 1. Eight group sessions of two hours duration, focusing on GMT and ADHD. The Group consists of six participants and is directed by one neuropsychologist and one psychologist. 2. Four individual sessions with the neuropsychologist/psychologist directing the Group where the participant is guided through the process of formulating GAS-goals. 3. Bi-weekly Telephone follow up focusing on GAS-goal attainment the thre first months following the Group session phase. |
| Control Group | No intervention | –Participants in the Control Group receive TAU. Participation in the study does not influence decisions regarding pharmacological interventions in either of the groups. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- CNS injury or disease other than hyperkinetic disorder, ADHD or ADD.
- Ongoing substance-abuse.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goal Attainment ScalingIndividual goals will be formulated and measured by Goal Attainment Scaling (GAS). GAS provides a method for quantifying the attainment of individualized goals, typically set in cognitive rehabilitation. Different levels of outcomes for each goal are operationalized in a five-point scale and given a numeric value. For each individual goal, minus two refers to the goal attainment much less than expected, minus one refers to a little less than expected, zero refers to expected outcome, plus one refers to a little bit better than expected and plus two refers to goal attainment much better than expected. The participants can establish as many goals as desired. Outcomes can be summed within different patient goals, as well as across patients to assess overall outcome of treatment outcomes. | Behavioural | Interventioh group |
Primary outcome
Behavior Rating Inventory of Executive Function for Adults (BRIEF-A)
Time frame: Change from baseline BRIEF-A at 8 months.
BRIEF-A is a standardized informant- and self report Inventory measuring different aspects of executive functions (Rabin et al, 2006). Data (BRIEF-A self report form) is collected at baseline (T1), at 2 months (T2), at 5 months (T3) and finally at 8 months (T4). BRIEF-A informant report form is collected at baseline (T1) and at 8 months (T4).
Goal Attainment Scaling (GAS).
Time frame: Change from baseline GAS at 5 months.
Individual goal attainment will be measured by GAS (Kiresuk and Sherman, 1968). Se description in the intervention-section. GAS-goals are formulated during the individual sessions and scored during biweekly telephone calls the three first months following the last group session.
2 secondary outcomes
Hopkins Symptom Checklist-25 (HSCL-25)
Time frame: Change from baseline HSCL-25 at 8 months.
The Adult ADHD Self Report Scale (ASRS-v.1.1)
Time frame: Change from baseline ASRS-v.1.1 at 8 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Background: PubMed 15841682Kessler RC, Adler L, Ames M, Demler O, Faraone S, Hiripi E, Howes MJ, Jin R, Secnik K, Spencer T, Ustun TB, Walters EE. The World Health Organization Adult ADHD Self-Report Scale (ASRS): a short screening scale for use in the general population. Psychol Med. 2005 Feb;35(2):245-56. doi: 10.1017/s0033291704002892.
- Background: PubMed 24185570Kiresuk TJ, Sherman RE. Goal attainment scaling: A general method for evaluating comprehensive community mental health programs. Community Ment Health J. 1968 Dec;4(6):443-53. doi: 10.1007/BF01530764.
- Background: PubMed 21369362Levine B, Schweizer TA, O'Connor C, Turner G, Gillingham S, Stuss DT, Manly T, Robertson IH. Rehabilitation of executive functioning in patients with frontal lobe brain damage with goal management training. Front Hum Neurosci. 2011 Feb 17;5:9. doi: 10.3389/fnhum.2011.00009. eCollection 2011.
- Background: PubMed 17166313Levine B, Stuss DT, Winocur G, Binns MA, Fahy L, Mandic M, Bridges K, Robertson IH. Cognitive rehabilitation in the elderly: effects on strategic behavior in relation to goal management. J Int Neuropsychol Soc. 2007 Jan;13(1):143-52. doi: 10.1017/S1355617707070178.
- Background: PubMed 16979868Rabin LA, Roth RM, Isquith PK, Wishart HA, Nutter-Upham KE, Pare N, Flashman LA, Saykin AJ. Self- and informant reports of executive function on the BRIEF-A in MCI and older adults with cognitive complaints. Arch Clin Neuropsychol. 2006 Oct;21(7):721-32. doi: 10.1016/j.acn.2006.08.004. Epub 2006 Sep 18.
- Background: PubMed 31375619Hypher RE, Brandt AE, Risnes K, Ro TB, Skovlund E, Andersson S, Finnanger TG, Stubberud J. Paediatric goal management training in patients with acquired brain injury: study protocol for a randomised controlled trial. BMJ Open. 2019 Aug 1;9(8):e029273. doi: 10.1136/bmjopen-2019-029273.
- Background: PubMed 25496433Stubberud J, Langenbahn D, Levine B, Stanghelle J, Schanke AK. Emotional health and coping in spina bifida after goal management training: a randomized controlled trial. Rehabil Psychol. 2015 Feb;60(1):1-16. doi: 10.1037/rep0000018. Epub 2014 Dec 15.
- Background: PubMed 27424292Tornas S, Lovstad M, Solbakk AK, Schanke AK, Stubberud J. Goal Management Training Combined With External Cuing as a Means to Improve Emotional Regulation, Psychological Functioning, and Quality of Life in Patients With Acquired Brain Injury: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2016 Nov;97(11):1841-1852.e3. doi: 10.1016/j.apmr.2016.06.014. Epub 2016 Jul 15.
- Derived from this study: PubMed 38046113Hanssen KT, Brevik EJ, Smastuen MC, Stubberud J. Improvement of anxiety in ADHD following goal-focused cognitive remediation: a randomized controlled trial. Front Psychol. 2023 Nov 17;14:1212502. doi: 10.3389/fpsyg.2023.1212502. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kjersti T Hanssen, PhD principal investigator
University Hospital, Akershus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal Attainment Scaling in people with Attention-Deficit Hyperactivity Disorder, Unspecified Type, run by University Hospital, Akershus at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavior Rating Inventory of Executive Function for Adults (BRIEF-A) (time frame: Change from baseline BRIEF-A at 8 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04638283, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.