Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Oslo | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventioh group | Experimental | The intervention consists of
|
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goal Attainment Scaling | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | Change from baseline GAS at 5 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline HSCL-25 at 8 months. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kjersti T Hanssen, PhD | University Hospital, Akershus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akershus University Hospital, DPS Nedre Romerike, Postboks 1000 | Loerenskog | 1478 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15841682 | Background | 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. | |
| 24185570 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
The participant is randomized by a lottery to participate either in the intervention group receiving the intervention described above or the controlgroup receiving TAU.
Not provided
Not provided
Not provided
Not provided
|
| 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) | Change from baseline ASRS-v.1.1 at 8 months. |
| Kiresuk 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. |
| 21369362 | Background | Levine 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. |
| 17166313 | Background | Levine 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. |
| 16979868 | Background | Rabin 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. |
| 31375619 | Background | Hypher 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. |
| 25496433 | Background | Stubberud 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. |
| 27424292 | Background | Tornas 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. |
| 38046113 | Derived | Hanssen 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. |