The Efficacy of Goal Focused, Non-Pharmacological Treatment for Persons With ADHD/ADD.

NCT04638283 | Completed

• 1 other identifier: Goal Focused ADHD Treatment
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.Bi-weekly telephone follow up the first three months preceding the group sessions, focusing on the attainment of GAS-goals.

Conditions

Attention-Deficit Hyperactivity Disorder, Unspecified Type

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (2)

• Hopkins Symptom Checklist-25 (HSCL-25)

  Change from baseline HSCL-25 at 8 months.

• The Adult ADHD Self Report Scale (ASRS-v.1.1)

  Change from baseline ASRS-v.1.1 at 8 months.

Study Arms (2)

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.

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.

Interventions

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.

Interventioh group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of Hyperkinetic disorder, ADHD or ADD. Both patients recently diagnosed at DPS and patients previously diagnosed can be included.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Akershus: lead
• University of Oslo: collaborator

Study Sites (1)

Akershus University Hospital, DPS Nedre Romerike, Postboks 1000

Loerenskog, 1478, Norway

Location

Related Publications (9)

• 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.

  PMID: 15841682 BACKGROUND

• 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.

  PMID: 24185570 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.

  PMID: 21369362 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.

  PMID: 17166313 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.

  PMID: 16979868 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.

  PMID: 31375619 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.

  PMID: 25496433 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.

  PMID: 27424292 BACKGROUND

• 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.

  PMID: 38046113 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Kjersti T Hanssen, PhD

  University Hospital, Akershus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD/Clinical neuropsychologist

Model Details: The participant is randomized by a lottery to participate either in the intervention group receiving the intervention described above or the controlgroup receiving TAU.

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: November 20, 2020
• Study Start: August 15, 2019
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: February 18, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)