Cognitive Restructuring in ADHD: Functional Training
Condition: Attention-deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The objective of the Cognitive Restructuring in ADHD: Functional Training (CRAFT) study is to
      develop a non-pharmacological intervention program for children with Attention Deficit
      Hyperactivity Disorder (ADHD). ADHD is a childhood onset clinical disorder of inattention,
      hyperactivity, and impulsivity. The present study will investigate the validity, feasibility
      and efficacy of this novel intervention.
    

Detailed description: 
      This study will consist of a pre-post design and will include three phases. Participants will
      be tested individually at SickKids at baseline and post-training, the training phase will
      take place at the participants' respective homes. Each participant's parent will complete a
      demographic/medical questionnaire. The cognitive and behavioural outcome measures of interest
      in this study will be the following:

      Planning and Organization: Tower Test from the Delis-Kaplan Executive Function System
      (D-KEFS; Delis et al, 2001) is a test of planning and problem solving abilities. Participants
      are asked to construct towers of discs on a set of pegs corresponding to a model. Raw scores
      reflect the participant's ability to use the fewest possible moves to achieve the tower
      depicted in the model.

      Response Inhibition: Inhibitory control will be measured using the Stop Signal Task (SST).
      The SST measures the ability to cancel an already initiated motor response. The primary
      outcome measure will be the participants' mean stop signal reaction time (SSRT).

      Inattentive and Hyperactivity Behaviour: Items associated with inattentiveness and
      hyperactivity from the Swanson, Nolan and Pelham Teacher and Parent Rating Scale version 4
      (SNAP IV) will be used to estimate behavioural symptoms associated with ADHD.

      Academic Performance: Academic efficiency and accuracy will be assessed using the fluency
      measures from the Woodcock Johnson III (WJ III) test of achievement.

      Spatial Span: The spatial span item from the Wechsler Intelligence Scale for Children (WISC)
      will be used to estimate the child's visuo-spatial span. The primary outcome measure will be
      the number of correctly recalled spatial locations.

      Working Memory: Working Memory will be tested using Spatial N-back 0,1,2.

      Phase 1: Baseline Session

      Children and their parents will participate in a 2 hour clinic session at SickKids. During
      this appointment, investigator/research staff will assess children's cognitive performances.
      The cognitive measures have been selected based on the range of processes commonly impaired
      in children with ADHD which will also be targeted by Mega Team. Both the training group and
      the control group will complete the same assessment battery. Tasks and questionnaires that
      will be included in this battery are;

        -  Spatial Span (working memory)

        -  WJ III

        -  Tower Test (D-KEFS)

        -  SST

        -  SNAP

        -  Demographic/Medical questionnaire

        -  Spatial N-back 0,1,2

      Spatial Working Memory has been shown to be impaired in ADHD. In this task, the experimenter
      will point to a sequence of spatial locations on a grid and children will be required to
      reproduce this sequence in a forward or backward order. The length of sequences will vary
      between sets of 2-7. The spatial span tasks will be scored based on the Spatial Span scoring
      rules and norms (WISC-IV Integrated).

      Academic efficiency and accuracy will be assessed using the fluency measures from the
      Woodcock Johnson III (WJ III) test of achievement. Participants will complete the reading
      fluency, math fluency and writing fluency subtests using alternate forms A and B in each
      assessment period to prevent retesting bias. This battery has been selected to be included in
      this study to provide objective measures of academic performance in areas where children with
      ADHD often show weakness (Czamara et al., 2013, Greven et al.,2013, Schmiedeler and
      Schneider, 2013).

      Tower Test (DKEFS subtest (Delis et al., 2001) is a test of planning and problem solving
      abilities. Planning and organizational deficits have been reported in children with ADHD
      (Grodzinsky and Diamond, 1992, Mataro et al., 1997, Wilcutt et al., 2005) and will be
      targeted by Mega Team. Participants will be asked to construct towers of discs on a set of
      pegs corresponding to a model. Raw scores reflecting the participant's ability to use the
      fewest possible moves to achieve the tower depicted in the model.

      The Stop Signal Test (SST) is a measure of response inhibition. Difficulties of response
      inhibition in ADHD have been reported by 82% of studies that have examined it. Response
      inhibition has been posited as an endophenotype for ADHD and shown to distinguish a group of
      children with ADHD from one with ADHD symptoms and one with conduct disorder. In the SST,
      participants will perform a choice reaction time task and will be instructed to respond as
      quickly and accurately as possible. On a portion of trials (e.g. 25%) a stop signal (a tone)
      will be presented and participants will be required to restrain their motor response. The
      delay between the go stimulus (the primary task) and the onset of the stop signal varies to
      determine the participant's ability to stop an already initiated motor response. This
      individualized stopping latency varies as a function of impulsivity. The stop-signal reaction
      time (SSRT) provides a measure of the ability to inhibit an already initiated response.

      The SNAP-IV parent 18-item Rating Scale is a standardized scale that measures symptoms
      associated with ADHD. This provides the opportunity to identify the child's behavioural
      issues relative to standardized norms. This measure includes the Diagnostic and Statistical
      Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for ADHD with items 1-9
      representing the inattentive subset of symptoms and items 10-18 representing the
      Hyperactivity/Impulsivity subset. Parents will be requested to fill out this scale at
      baseline, during training and post-training.

      Spatial N-back 0,1,2 - The N-Back task requires on-line monitoring, updating, and
      manipulation of remembered information and measures key processes within working memory. In
      the N-Back task, the participant is required to monitor a series of stimuli and to respond
      whenever a stimulus is presented that is the same as the one presented n trials previously,
      where n is a pre-specified integer, usually 0, 1, or 2. The current study will use spatial
      location (spatial) paradigms.

      Phase 2: the Training Sessions

      In this phase, children in the treatment group will train at home on a computer with internet
      connection. They will be instructed to practice Mega Team for 30-35 minutes a day,
      approximately 5 days a week for a minimum of 21 sessions and a maximum of 25 sessions. The
      minimum value of 21 sessions has been selected based on findings of prior research. Majority
      of studies have been able to capture significant training-induced improvements after 21
      sessions. The maximum training session of 25 days has been set to control for variability
      within and between our groups.

      Performance on Mega Team will automatically upload to a secure website which will be
      monitored by the experimenters for both compliance and data analyses purposes. For example,
      research staff will know how often and how long the participants trained on Mega Team. One of
      the major objective of this study is to design a training program that is inherently engaging
      to children so that it will be easier to comply with the training schedule. It is possible
      that the presence of certain comorbid conditions such as ODD will affect adherence. However,
      the goal is to avoid compliance issues by ensuring that Mega Team is game-like and
      interesting to all children.

      Children in the control group will play video-games as usual. Participants' parent/guardian
      in both groups (Treatment, Control) will be asked to complete a video game usage log weekly
      to record the type and duration of video game playing. Parents of both groups will also be
      required to fill out the SNAP-IV parent 18-item questionnaire once a week during the training
      phase. This questionnaire will provide a measure of change in behaviour.

      Phase 3: the Post-Training Session

      Following the completion of the training, families from both the treatment and the control
      groups will be scheduled for another 2 hour clinic session. The time between the completion
      of training and post-training appointment will range between 2-7 days. At this appointment,
      families will be asked to complete the same tasks and questionnaires that were administered
      to them during the baseline session. In this session, children will also be asked to fill out
      the Video-game Questionnaire. At the end of the post-training visit participants in the
      control group will be sent home with access to the Mega Team game for the same duration as
      the treatment group.
    

Intervention name(s): Mega Team-videogame
Intervention type(s): Other
Intervention description(s): Subjects randomly assigned to the treatment group will be instructed to practice Mega Team for 30-35 minutes a day, approximately 5 days a week for a minimum of 21 days and a maximum of 25 days.
Other intervention name(s): Mega Team
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment