Executive Function/Metacognitive Training for At-Risk Preschoolers
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to see if an intervention training executive functions like
      attention, working memory, and self-regulation for preschoolers at risk for
      Attention-Deficit/Hyperactivity Disorder is feasible, acceptable to families, and improves
      attention, behavior, and functioning.
    

Detailed description: 
      Disruptive behavior disorders, particularly Attention-Deficit/Hyperactivity Disorder (ADHD),
      constitute one of the most common diagnoses in preschool children. Disruptive behaviors are a
      major public health problem including causing significant emotional distress for caregivers
      and children, expulsion from daycare or early education settings, demands on caregiver's
      time, accident proneness and other safety concerns. However, few evidence-based early
      interventions exist for preschoolers with attention and behavior problems, which is critical
      because they are strongly suggested as the first line of treatment for preschoolers with
      ADHD. Because executive functioning (EF) has been consistently been proposed as a putative
      factor in the development of disruptive behavior disorders an intervention targeting EF
      (e.g., inhibition, working memory), attention, and metacognition during early childhood could
      likely affect the development of disruptive behavior disorders in preschoolers. Indeed, EF
      skills are identified by kindergarten teachers as primary prerequisites for school success.
      EF deficits independently contribute to poorer outcomes in ADHD, and have been linked
      directly to academic and social functioning deficits. Given that EF and brain development are
      rapidly developing during the preschool years, preschoolers may benefit most from an early
      intervention targeting EF skills. Investigators have developed a promising intervention,
      Executive Training of Attention and Metacognition (ETAM), for preschoolers, and have
      conducted a small preliminary open trial demonstrating the initial acceptability of the
      intervention. Investigators also found significant moderate effect sizes on objective
      measures of EF and moderate to large effect size reductions in ratings of inattention and
      behavioral symptoms by parents, clinicians, and teachers. A randomized clinical trial (RCT)
      is needed to investigate if these positive effects on executive functioning, attention, and
      behavior are due to ETAM or to the effect of parental attention and/or a placebo effect.
      Investigators propose to assess the feasibility of a design for a future RCT. Investigators
      will develop an attention control (AC) comparison group and assess the feasibility of:
      identifying, enrolling and retaining preschoolers at-risk for ADHD, randomization choices,
      the measurement of EF and functional outcomes, and delivery protocol for both AC and ETAM by
      conducting a pilot RCT with 60 children at-risk for ADHD. Exploratory aims include assessing
      whether children in the ETAM group show gains compared to those in AC on targeted (trained)
      outcomes (i.e., measures of EF) and untrained outcomes (i.e., ADHD symptoms, academic
      readiness, social competence). Investigators will also assess whether gains are maintained as
      well as investigate potential moderators/mediators.
    

Intervention name(s): Executive Training of Attention and Metacognition (ETAM); Attention Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): ETAM is an 8-week intervention involving weekly concurrent child (n=~6 per group) and parent intervention groups. The ETAM groups will be 1 hour in length (except for the first session which will be 2 hours).; Attention Control is an 8-week intervention involving weekly concurrent child (n=~6 per group) and parent groups that control for the effects of attention. The groups will be 1 hour in length (except for the first session which will be 2 hours).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Attention-Deficit/Hyperactivity Disorder; Executive function; Preschooler; Metacognition