Animal Assisted Intervention With Dogs for Children With ADHD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Animal Assisted Intervention With Dogs for Children With Attention Deficit/Hyperactivity Disorder; Exploring Candidate Physiological Markers of Response to AAI

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Behavioral: Behavioral Social Skills Training
* Behavioral: Animal Assisted Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets research criteria for a diagnosis of ADHD based on the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) Has never taken stimulant medication or has had at least a 6 week 'wash-out' period from stimulant medicines not related to enrollment in the study. Exclusion Criteria: Is currently taking stimulant medications or has taken stimulant medications within the last 6 weeks Allergy to dogs Significant fear of dogs Family history or history of cruelty to animals Meets research criteria for a diagnosis of Autism Spectrum Disorder (ASD) based on the K-SADS and SRS-2 total raw score in the 'severe range' Meets research criteria for a diagnosis of Major Depressive Disorder on the K-SADS Meets research criteria for a diagnosis of Schizophrenia on the K-SADS

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Psychosocial Treatment as Usual<br>Participants assigned to the active comparator arm will receive active non-pharmacological treatment utilizing behavioral social skills training strategies previously found to be effective in reducing symptoms of ADHD and improving social skills for children with ADHD | Behavioral: Behavioral Social Skills Training<br>* 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.<br>|
| Experimental: Animal Assisted Intervention<br>Participants assigned to the experimental arm will receive active non-pharmacological treatment utilizing behavioral social skills training strategies previously found to be effective in reducing symptoms of ADHD and improving social skills for children with ADHD accompanied by live therapy dogs | Behavioral: Animal Assisted Intervention<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline on the ADHD-Rating Scale (ADHD-RS) at 8 weeks | Categorical and dimensional parent and teacher ratings of symptoms of inattention, hyperactivity, and impulsivity (lowered scores indicate improvement). | Change from Baseline at 8 weeks | 
| Change from Baseline on the ADHD-Rating Scale (ADHD-RS) at 16 weeks follow-up | Categorical and dimensional parent and teacher ratings of symptoms of inattention, hyperactivity, and impulsivity (lowered scores indicate improvement) | Change from Baseline at 16 weeks | 
| Change from Baseline on the Self-Perception Profile for Children (SPPC) at 8 weeks | Dimensional self-report ratings of child self-perception (higher scores indicate improvement) | Change from Baseline at 8 weeks | 
| Change from Baseline on the Self-Perception Profile for Children (SPPC) at 16 weeks | Dimensional self-report ratings of child self-perception (higher scores indicate improvement) | Change from Baseline at 16 weeks | 
| Change from Baseline on the Social Responsiveness Scale (SRS-2) at 8 weeks | Categorical parent ratings of child social response styles (lower scores indicate improvement) | Change from Baseline at 8 weeks | 
| Change from Baseline on the Social Responsiveness Scale (SRS-2) at 16 weeks | Categorical parent ratings of child social response styles (lower scores indicate improvement) | Change from Baseline at 16 weeks | 
| Change from Baseline on the Social Skills Improvement System Rating Scales (SSIS-RS) at 8 weeks | Categorical parent ratings of child social skills (higher scores indicate improvement) and problem behaviors (lower scores indicate improvement) | Change from Baseline at 8 weeks | 
| Change from Baseline on the Social Skills Improvement System Rating Scales (SSIS-RS) at 16 weeks | Categorical parent ratings of child social skills (higher scores indicate improvement) and problem behaviors (lower scores indicate improvement) | Change from Baseline at 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Diurnal Salivary Cortisol levels at 8 weeks | Salivary analyte as a bio-marker for Hypothalamic Pituitary-Adrenal Axis activity (lower levels indicate improvement) | Change from Baseline at 8 weeks | 
| Change in Diurnal Salivary Cortisol levels at 16 weeks | Salivary analyte as a bio-marker for Hypothalamic Pituitary-Adrenal Axis activity (lower levels indicate improvement) | Change from Baseline at 16 weeks | 
| Acute Salivary Cortisol level | Salivary analyte as a bio-marker for Hypothalamic Pituitary-Adrenal Axis activity (lower levels indicate improvement) | 1 week | 
| Acute Salivary Cortisol level | Salivary analyte as a bio-marker for Hypothalamic Pituitary-Adrenal Axis activity (lower levels indicate improvement) | 4 weeks | 
| Acute Salivary Cortisol level | Salivary analyte as a bio-marker for Hypothalamic Pituitary-Adrenal Axis activity (lower levels indicate improvement) | 8 weeks | 
| Change in Diurnal Salivary Alpha-Amylase at 8 weeks | Salivary analyte as a bio-marker for Autonomic Nervous System activity (interpretation dependent on baseline levels) | Change from Baseline at 8 weeks | 
| Change in Diurnal Salivary Alpha-Amylase at 16 weeks | Salivary analyte as a bio-marker for Autonomic Nervous System activity (interpretation dependent on baseline levels) | Change from Baseline at 16 weeks | 
| Acute Salivary Alpha-Amylase level | Salivary analyte as a bio-marker for Autonomic Nervous System activity (interpretation dependent on baseline levels) | 1 week | 
| Acute Salivary Alpha-Amylase level | Salivary analyte as a bio-marker for Autonomic Nervous System activity (interpretation dependent on baseline levels) | 4 weeks | 
| Acute Salivary Alpha-Amylase level | Salivary analyte as a bio-marker for Autonomic Nervous System activity (interpretation dependent on baseline levels) | 8 weeks | 
| Change in Salivary Uric Acid at 8 weeks | Salivary analyte as a candidate bio-marker for disruptive behavior (lower levels indicate improvement) | Change from Baseline at 8 weeks | 
| Change in Salivary Uric Acid at 16 weeks | Salivary analyte as a candidate bio-marker for disruptive behavior (lower levels indicate improvement) | Change from Baseline at 16 weeks | 
| Acute Salivary Uric Acid level | Salivary analyte as a candidate bio-marker for disruptive behavior (lower levels indicate improvement) | 1 week | 
| Acute Salivary Uric Acid level | Salivary analyte as a candidate bio-marker for disruptive behavior (lower levels indicate improvement) | 4 weeks | 
| Acute Salivary Uric Acid level | Salivary analyte as a candidate bio-marker for disruptive behavior (lower levels indicate improvement) | 8 weeks | 
| Change in Heart Rate Variability at 8 weeks | Bio-marker for Autonomic Nervous System activity (increased HRV indicates improvement) | Change from Baseline at 8 weeks | 
| Change in Heart Rate Variability at 16 weeks | Bio-marker for Autonomic Nervous System activity (increased HRV indicates improvement) | Change from Baseline at 16 weeks | 
| Acute Heart Rate Variability | Bio-marker for Autonomic Nervous System activity (increased HRV indicates improvement) | 1 week | 
| Acute Heart Rate Variability | Bio-marker for Autonomic Nervous System activity (increased HRV indicates improvement) | 4 weeks | 
| Acute Heart Rate Variability | Bio-marker for Autonomic Nervous System activity (increased HRV indicates improvement) | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Animal Assisted Intervention, Social Skills Training