Clinical trial NCT05102344: Animal Assisted Intervention With Dogs for Children With ADHD
Official title: Animal Assisted Intervention With Dogs for Children With Attention Deficit/Hyperactivity Disorder; Exploring Candidate Physiological Markers of Response to AAI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Animal Assisted Intervention
Social Skills Training
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 39
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline on the ADHD-Rating Scale (ADHD-RS) at 8 weeks
timeFrame: Change from Baseline at 8 weeks
measure: Change from Baseline on the ADHD-Rating Scale (ADHD-RS) at 16 weeks follow-up
timeFrame: Change from Baseline at 16 weeks
measure: Change from Baseline on the Self-Perception Profile for Children (SPPC) at 8 weeks
timeFrame: Change from Baseline at 8 weeks
measure: Change from Baseline on the Self-Perception Profile for Children (SPPC) at 16 weeks
timeFrame: Change from Baseline at 16 weeks
measure: Change from Baseline on the Social Responsiveness Scale (SRS-2) at 8 weeks
timeFrame: Change from Baseline at 8 weeks
measure: Change from Baseline on the Social Responsiveness Scale (SRS-2) at 16 weeks
timeFrame: Change from Baseline at 16 weeks
measure: Change from Baseline on the Social Skills Improvement System Rating Scales (SSIS-RS) at 8 weeks
timeFrame: Change from Baseline at 8 weeks
measure: Change from Baseline on the Social Skills Improvement System Rating Scales (SSIS-RS) at 16 weeks
timeFrame: Change from Baseline at 16 weeks
Secondary outcomes:
measure: Change in Diurnal Salivary Cortisol levels at 8 weeks
timeFrame: Change from Baseline at 8 weeks
measure: Change in Diurnal Salivary Cortisol levels at 16 weeks
timeFrame: Change from Baseline at 16 weeks
measure: Acute Salivary Cortisol level
timeFrame: 1 week
measure: Acute Salivary Cortisol level
timeFrame: 4 weeks
measure: Acute Salivary Cortisol level
timeFrame: 8 weeks
measure: Change in Diurnal Salivary Alpha-Amylase at 8 weeks
timeFrame: Change from Baseline at 8 weeks
measure: Change in Diurnal Salivary Alpha-Amylase at 16 weeks
timeFrame: Change from Baseline at 16 weeks
measure: Acute Salivary Alpha-Amylase level
timeFrame: 1 week
measure: Acute Salivary Alpha-Amylase level
timeFrame: 4 weeks
measure: Acute Salivary Alpha-Amylase level
timeFrame: 8 weeks
measure: Change in Salivary Uric Acid at 8 weeks
timeFrame: Change from Baseline at 8 weeks
measure: Change in Salivary Uric Acid at 16 weeks
timeFrame: Change from Baseline at 16 weeks
measure: Acute Salivary Uric Acid level
timeFrame: 1 week
measure: Acute Salivary Uric Acid level
timeFrame: 4 weeks
measure: Acute Salivary Uric Acid level
timeFrame: 8 weeks
measure: Change in Heart Rate Variability at 8 weeks
timeFrame: Change from Baseline at 8 weeks
measure: Change in Heart Rate Variability at 16 weeks
timeFrame: Change from Baseline at 16 weeks
measure: Acute Heart Rate Variability
timeFrame: 1 week
measure: Acute Heart Rate Variability
timeFrame: 4 weeks
measure: Acute Heart Rate Variability
timeFrame: 8 weeks
Other outcomes:
measure: Observation of Human-Animal Interaction for Research Coding System (OHAIRE)
timeFrame: 1 week
measure: Observation of Human-Animal Interaction for Research Coding System (OHAIRE)
timeFrame: 4 weeks
measure: Observation of Human-Animal Interaction for Research Coding System (OHAIRE)
timeFrame: 8 weeks
measure: Observation of in-Vivo Pro-social Behavior
timeFrame: 1 week
measure: Observation of in-Vivo Pro-social Behavior
timeFrame: 4 weeks
measure: Observation of in-Vivo Pro-social Behavior
timeFrame: 8 weeks
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
Study officials:
affiliation: University of California, Irvine
name: Sabrina EB Schuck, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: