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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04638283
Recruitment Status : Recruiting
First Posted : November 20, 2020
Last Update Posted : November 20, 2020
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Kjersti Traeland Hanssen, University Hospital, Akershus

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 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.


Condition or disease Intervention/treatment Phase
Attention-Deficit Hyperactivity Disorder, Unspecified Type Behavioral: Goal Attainment Scaling Not Applicable

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

  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-v1.1) 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: The Efficacy of Goal Focused, Non-Pharmacological Treatment for Persons With ADHD/ADD. A Randomized Controlled Trial.
Actual Study Start Date : August 15, 2019
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Interventioh group

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
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.

No Intervention: Control Group
Participants in the Control Group receive TAU. Participation in the study does not influence decisions regarding pharmacological interventions in either of the groups.



Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. Hopkins Symptom Checklist-25 (HSCL-25) [ Time Frame: Change from baseline HSCL-25 at 8 months. ]
    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.

  2. The Adult ADHD Self Report Scale (ASRS-v.1.1) [ Time Frame: Change from baseline ASRS-v.1.1 at 8 months. ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of Hyperkinetic disorder, ADHD or ADD. Both patients recently diagnosed at DPS and patients previously diagnosed can be included.
  2. 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.
  3. Motivation for working with the executive problems in order to increase coping in everyday life.
  4. Adequate language skills to participate in group discussions without any need for an interpreter.

Exclusion Criteria:

  1. CNS injury or disease other than hyperkinetic disorder, ADHD or ADD.
  2. Ongoing substance-abuse.
  3. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04638283


Contacts
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Contact: Kjersti T Hanssen, PhD +47 95723772 kjerstipost@gmail.com
Contact: Jan Stubberud, PhD +47 22854813 jan.stubberud@psykologi.uio.no

Locations
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Norway
Akershus University Hospital, DPS Nedre Romerike, Postboks 1000 Recruiting
Loerenskog, Norway, 1478
Contact: Kjersti T Hanssen, PhD    +47 95723772    kjerstipost@gmail.com   
Contact: Katrine Hippe, Leader    +47 63894060      
Sponsors and Collaborators
University Hospital, Akershus
University of Oslo
Investigators
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Principal Investigator: Kjersti T Hanssen, PhD University Hospital, Akershus
Publications:

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Responsible Party: Kjersti Traeland Hanssen, PhD/Clinical neuropsychologist, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT04638283    
Other Study ID Numbers: Goal Focused ADHD Treatment
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders