Animal Assisted Intervention With Dogs for Children With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      This pilot study aims to replicate results of a previously studied novel, non-pharmacological
      psychosocial intervention for children with ADHD, utilizing an Animal Assisted Intervention
      with therapy dogs combined with traditional social skills training (AAI) compared to
      psychosocial treatment as usual with social skills training alone (TAU). This study also aims
      to determine if candidate physiological markers of HPA axis and ANS activity differ between
      groups and if these markers moderate response to the interventions.
    

Detailed description: 
      Attention-Deficit/Hyperactivity Disorder (ADHD) is the most commonly occurring
      neurodevelopmental disorder in the United States, with current prevalence rates between 8%
      and 11%, up from an estimated 5% in 2003. Despite decades of research, individuals with ADHD
      continue to be at significantly greater risk for poor life outcomes compared to non-affect
      peers. Evidence-based interventions for ADHD include stimulant medications and psychosocial
      treatments, but these practices are not always feasible or acceptable due to adverse
      side-effects, cost, availability, and poor treatment adherence. ADHD is considered to be a
      result of a physiological disruption of select catecholaminergic systems (e.g. dopamine and
      norepinephrine) and related under-arousal of cognitive functions of the pre-frontal cortex
      involved in executive functioning (EF). Research indicates that AAI with dogs is effective
      for improving social-behavioral outcomes related to EF deficits. The mechanisms by which AAI
      improves outcomes for this group and mediators of these outcomes, however, is not yet
      understood. These gaps in understanding hinder progress in the application of AAI, limiting
      the acceptability and availability of this integrative health care practice. Recent research
      in other populations suggests that AAI acts on hypothalamic-pituitary-adrenal (HPA) axis
      activity, reducing physiological stress Children with ADHD, however, present with different
      Autonomic Nervous System (ANS) response patterns when compared to typically developing
      children and children with other mental health disorders and this phenomenon points to
      altered physiological activity in response to stress, social feedback, and emotional stimuli
      when compared to their peers. The bio-social mechanistic hypothesis proposed in this study
      contends that dogs may elicit physiological responses related to cognitive arousal of EF
      systems, thereby enhancing response to treatment in children with ADHD. Furthermore, given
      the heterogeneity of impairment and high comorbidity with other mental health disorders among
      children with ADHD and the prevalence of ADHD across cultures, race and ethnicity, individual
      differences in response to AAI and in child/animal interaction may potentially mediate
      response to AAI. This research will explore these gaps by: 1) replicating findings from a
      previous AAI RCT on social-behavioral outcomes, 2) exploring candidate physiological
      responses to AAI over time, and 3) ascertaining if individual differences during AAI mediate
      primary and/or exploratory main outcomes. This study hypothesizes AAI will result in enhanced
      social-behavioral outcomes and improved diurnal patterns of HPA and ANS for these children.
      Furthermore, it is suspected acute physiological responses to AAI (markers of HPA & ANS) and
      social interaction quality (child/child and child/dog) will mediate main outcomes. To explore
      these hypotheses, the investigators will conduct an exploratory parallel-group randomized
      controlled clinical trial with 48 young children with ADHD, participating in psychosocial
      intervention with or without AAI using a previously manualized AAI model developed and found
      successful in prior work. This work will yield the first information on candidate mechanisms
      thought to play an important role in AAI for children with ADHD, thus laying foundations for
      later submission of a fully powered, multi-site randomized clinical trial aimed to better
      inform approaches refined for this group, and promote acceptability and generalizability of
      AAI with children with special needs.
    

Intervention name(s): Behavioral Social Skills Training; Animal Assisted Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Behavioral Social Skills Training treatment as usual will include small group semi-structured play, didactic instruction and role-play of basic social skills, including assertion, ignoring provocation, accepting consequences, problem solving, following directions, and self-regulation.; Behavioral Social Skills Training treatment as usual will include small group semi-structured play, didactic instruction and role-play of basic social skills, including assertion, ignoring provocation, accepting consequences, problem solving, following directions, and self-regulation accompanied by trained therapy dogs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Animal Assisted Intervention; Social Skills Training