Animal Assisted Intervention With Dogs for Children With ADHD

Attention Deficit Hyperactivity Disorder Clinical Trial

— PACK-PM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05102344
• Other study ID #: 20206069
• Status: Completed
• Phase: N/A
• Start date: September 17, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: January 2024
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 31, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Behavioral:
• Behavioral Social Skills Training
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.
• Animal Assisted Intervention
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

Locations

Country	Name	City	State
United States	University of California, Irvine	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Observation of Human-Animal Interaction for Research Coding System (OHAIRE)	Systematic coding of child-animal interaction captured by digital video recording	1 week
Other	Observation of Human-Animal Interaction for Research Coding System (OHAIRE)	Systematic coding of child-animal interaction captured by digital video recording	4 weeks
Other	Observation of Human-Animal Interaction for Research Coding System (OHAIRE)	Systematic coding of child-animal interaction captured by digital video recording	8 weeks
Other	Observation of in-Vivo Pro-social Behavior	Systematic coding of child-child interaction captured by digital video recording	1 week
Other	Observation of in-Vivo Pro-social Behavior	Systematic coding of child-child interaction captured by digital video recording	4 weeks
Other	Observation of in-Vivo Pro-social Behavior	Systematic coding of child-child interaction captured by digital video recording	8 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Acute Salivary Cortisol level	Salivary analyte as a bio-marker for Hypothalamic Pituitary-Adrenal Axis activity (lower levels indicate improvement)	1 week
Secondary	Acute Salivary Cortisol level	Salivary analyte as a bio-marker for Hypothalamic Pituitary-Adrenal Axis activity (lower levels indicate improvement)	4 weeks
Secondary	Acute Salivary Cortisol level	Salivary analyte as a bio-marker for Hypothalamic Pituitary-Adrenal Axis activity (lower levels indicate improvement)	8 weeks
Secondary	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
Secondary	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
Secondary	Acute Salivary Alpha-Amylase level	Salivary analyte as a bio-marker for Autonomic Nervous System activity (interpretation dependent on baseline levels)	1 week
Secondary	Acute Salivary Alpha-Amylase level	Salivary analyte as a bio-marker for Autonomic Nervous System activity (interpretation dependent on baseline levels)	4 weeks
Secondary	Acute Salivary Alpha-Amylase level	Salivary analyte as a bio-marker for Autonomic Nervous System activity (interpretation dependent on baseline levels)	8 weeks
Secondary	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
Secondary	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
Secondary	Acute Salivary Uric Acid level	Salivary analyte as a candidate bio-marker for disruptive behavior (lower levels indicate improvement)	1 week
Secondary	Acute Salivary Uric Acid level	Salivary analyte as a candidate bio-marker for disruptive behavior (lower levels indicate improvement)	4 weeks
Secondary	Acute Salivary Uric Acid level	Salivary analyte as a candidate bio-marker for disruptive behavior (lower levels indicate improvement)	8 weeks
Secondary	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
Secondary	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
Secondary	Acute Heart Rate Variability	Bio-marker for Autonomic Nervous System activity (increased HRV indicates improvement)	1 week
Secondary	Acute Heart Rate Variability	Bio-marker for Autonomic Nervous System activity (increased HRV indicates improvement)	4 weeks
Secondary	Acute Heart Rate Variability	Bio-marker for Autonomic Nervous System activity (increased HRV indicates improvement)	8 weeks