The Efficacy of Goal Focused, Non-Pharmacological Treatment for Persons With ADHD/ADD.
Condition: Attention-Deficit Hyperactivity Disorder, Unspecified Type
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

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.
    

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.
    

Intervention name(s): Goal Attainment Scaling
Intervention type(s): Behavioral
Intervention description(s): 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.
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