Animal Assisted Intervention With Dogs for Children With ADHD (PACK-PM)

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

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Behavioral: Behavioral Social Skills Training; Behavioral: Animal Assisted Intervention

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 Randomized Controlled Trial 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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92697
      • University of California, Irvine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 9 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Autism Specturm Rating Scale (ASRS) 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Psychosocial Treatment as Usual; 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; 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.
Experimental: Animal Assisted Intervention; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADHD-Rating Scale (ADHD-RS) at 8 Weeks	Attention Deficit/Hyperactivity Rating Scale for Parents is a categorical and dimensional parent and teacher ratings of symptoms of inattention, hyperactivity, and impulsivity (min: 0.00, max: 54.00; lower scores indicate less impairment).	At 8 weeks
ADHD-Rating Scale (ADHD-RS) at 16 Weeks Follow-up	Attention Deficit/Hyperactivity Rating Scale for Parents is a categorical and dimensional parent and teacher ratings of symptoms of inattention, hyperactivity, and impulsivity (min: 0.00, max: 54.00; lower scores indicate less impairment).	At 16 weeks
Self-Perception Profile for Children (SPPC) at 8 Weeks	The Self-Perception Profile for Children (SPPC; Harter) uses a 4-point Likert scale, where each item is scored from 1 to 4. The SPPC measures self-perceptions across six domains: Scholastic Competence, Social Acceptance, Athletic Competence, Physical Appearance, Behavioral Conduct, and Global Self-Worth, with a total score summing and averaging 36 items with a total score of 1 being the lowest perceived competence or adequacy, and a score of 4 represents the highest level of competence or adequacy.	At 8 weeks
Self-Perception Profile for Children (SPPC) at 16 Weeks	The Self-Perception Profile for Children (SPPC; Harter) uses a 4-point Likert scale, where each item is scored from 1 to 4. The SPPC measures self-perceptions across six domains: Scholastic Competence, Social Acceptance, Athletic Competence, Physical Appearance, Behavioral Conduct, and Global Self-Worth, with a total score summing and averaging 36 items with a total score of 1 being the lowest perceived competence or adequacy, and a score of 4 represents the highest level of competence or adequacy.	At 16 weeks
Social Responsiveness Scale (SRS-2) at 8 Weeks	The Social Responsiveness Scale, second edition, (SRS-2: Constantino) measures parent ratings of symptoms of Autism Spectrum Disorder for individuals (preschool to adulthood). It is a 65-item, 4-point Likert rating scale with item scores ranging (1-4). Total scores are summed from 5 sub-scales and transformed to a Total T-score reported above. The population mean for the Total T-score value is 50 with a standard deviation of 10, with scores of 59 and below considered normal, and higher scores indicating a greater likelihood of a clinical diagnosis of ASD.	At 8 weeks
Social Responsiveness Scale (SRS-2) at 16 Weeks	The Social Responsiveness Scale, second edition, (SRS-2: Constantino) measures parent ratings of symptoms of Autism Spectrum Disorder for individuals (preschool to adulthood). It is a 65-item, 4-point Likert rating scale with item scores ranging (1-4). Total scores are summed from 5 sub-scales and transformed to a Total T-score reported above. The population mean for the Total T-score value is 50 with a standard deviation of 10, with scores of 59 and below considered normal, and higher scores indicating a greater likelihood of a clinical diagnosis of ASD.	At 16 weeks
Social Skills Improvement System Rating Scales (SSIS-RS) Social Skills at 8 Weeks	The Social Skills Improvement System Rating Scales, parent version, social skills sub-scale (SSIS-RS; Gresham) is a norm-referenced rating form used to assess social skills in children and adolescents aged 3-18. The Social Skills sub-scale is composed of 46-items and utilizes a 4-point Likert scale, with item scores ranging from 0-3. The total sub-scale summed score is age-adjusted and scaled scores have a mean of 100 and a standard deviation of 15, with higher scores representing better social skills.	At 8 weeks
Social Skills Improvement System Rating Scales (SSIS-RS) Social Skills at 16 Weeks	The Social Skills Improvement System Rating Scales, parent version, social skills sub-scale (SSIS-RS; Gresham) is a norm-referenced rating form used to assess social skills in children and adolescents aged 3-18. The Social Skills sub-scale is composed of 46-items and utilizes a 4-point Likert scale, with item scores ranging from 0-3. The total sub-scale summed score is age-adjusted and scaled scores have a mean of 100 and a standard deviation of 15, with higher scores representing better social skills.	At 16 weeks
Social Skills Improvement System Rating Scale (SSIS-RS) Problem Behaviors at 8 Weeks	The Social Skills Improvement System Rating Scales, parent version, problem behaviors sub-scale (SSIS-RS; Gresham) is a norm-referenced rating form used to assess problem behaviors in children and adolescents aged 3-18. The Problem Behaviors sub-scale is composed of 33-items and utilizes a 4-point Likert scale, with item scores ranging from 0-3. The total sub-scale summed score is age-adjusted and scaled scores have a mean of 100 and a standard deviation of 15, with higher scores representing more problematic behavior.	At 8 Weeks
Social Skills Improvement System Rating Scale (SSIS-RS) Problem Behaviors at 16 Weeks	The Social Skills Improvement System Rating Scales, parent version, problem behaviors sub-scale (SSIS-RS; Gresham) is a norm-referenced rating form used to assess problem behaviors in children and adolescents aged 3-18. The Problem Behaviors sub-scale is composed of 33-items and utilizes a 4-point Likert scale, with item scores ranging from 0-3. The total sub-scale summed score is age-adjusted and scaled scores have a mean of 100 and a standard deviation of 15, with higher scores representing more problematic behavior.	At 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diurnal Salivary Cortisol Levels at 8 Weeks	Cortisol is a stress-sensitive hormone which follows a diurnal cycle. Diurnal change in cortisol is typically measured as a negative slope value with average scores often around -1.00, with steeper (more negative) scores associated with well-being and flatter diurnal cortisol slopes associated with chronic psychosocial stress and poor outcomes in past theory and research. Secreted cortisol levels were measured from saliva samples were collected at three time points (awakening, morning, bedtime) across two days at the end of the intervention (at 8 weeks from baseline) to calculate end of treatment group mean slopes.	At 8 weeks
Diurnal Salivary Cortisol Levels at 16 Weeks	Cortisol is a stress-sensitive hormone which follows a diurnal cycle. Diurnal change in cortisol is typically measured as a negative slope value with average scores often around -1.00, with steeper (more negative) scores associated with well-being and flatter diurnal cortisol slopes associated with chronic psychosocial stress and poor outcomes in past theory and research. Secreted cortisol levels were measured from saliva samples were collected at three time points (awakening, morning, bedtime) across two days at 8 weeks following end of the intervention (at 16 weeks from baseline) to calculate follow-up group mean slopes.	At 16 weeks
Acute Salivary Cortisol Level (In-session Week 1)	Cortisol is a stress-sensitive hormone which may be acutely sensitive to intervention. Secreted cortisol levels were measured from saliva samples collected at three time points during intervention sessions (arrival, 20 minutes later, and 40 minutes into the session) and to determine a mean cortisol level for each participant and calculate acute group mean averages at week 1.	1 week
Acute Salivary Cortisol Level (In-session Week 4)	Cortisol is a stress-sensitive hormone which may be acutely sensitive to intervention. Secreted cortisol levels were measured from saliva samples collected at three time points during intervention sessions (arrival, 20 minutes later, and 40 minutes into the session) and to determine a mean cortisol level for each participant and calculate acute group mean averages at week 4.	4 weeks
Acute Salivary Cortisol Level (In-session Week 8)	Cortisol is a stress-sensitive hormone which may be acutely sensitive to intervention. Secreted cortisol levels were measured from saliva samples collected at three time points during intervention sessions (arrival, 20 minutes later, and 40 minutes into the session) and to determine a mean cortisol level for each participant and calculate acute group mean averages at week 8.	8 weeks
Alpha-Amylase From Saliva at 8 Weeks	Salivary Alpha Amylase (sAA) is an enzyme marker of the autonomic/sympathetic nervous system (ANS/SNS) steadily rises over the day. Diurnal change is measured as a positive slope value. Steeper slope indicates faster increase in sAA levels and has been associated with poor health outcomes. Secreted sAA levels were measured from saliva collected at three time points (awakening, morning, bedtime) over two days before the last intervention intervention session (week 8) to calculate baseline group mean slope. Interpretation of values requires consideration of the context and was collected at 8-weeks for comparison to other variables.	At 8 weeks
Alpha-Amylase From Saliva at 16 Weeks	Salivary Alpha Amylase (sAA) is an enzyme marker of the autonomic/sympathetic nervous system (ANS/SNS) steadily rises over the day. Diurnal change is measured as a positive slope value. Steeper slope indicates faster increase in sAA levels and has been associated with poor health outcomes. Secreted sAA levels were measured from saliva collected at three time points (awakening, morning, bedtime) over two days before the follow-up session (week 16, or 8 weeks post-intervention) to calculate baseline group mean slope. Interpretation of values requires consideration of the context and was collected at 16-weeks for comparison to other variables.	At 16 weeks
Acute Salivary Alpha-Amylase Level (In-session Week 1)	Salivary alpha-amylase (sAA) is a biomarker of the autonomic/sympathetic nervous system (ANS/SNS) which may be acutely sensitive to intervention. Secreted sAA levels were measured from saliva samples collected at three time points during intervention sessions (arrival, 20 minutes later, and 40 minutes into the session) to determine a mean sAA level for each participant and calculate acute group mean averages at week 1.	1 week
Acute Salivary Alpha-Amylase Level (In-session Week 4)	Salivary alpha-amylase (sAA) is a biomarker of the autonomic/sympathetic nervous system (ANS/SNS) which may be acutely sensitive to intervention. Secreted sAA levels were measured from saliva samples collected at three time points during intervention sessions (arrival, 20 minutes later, and 40 minutes into the session) to determine a mean sAA level for each participant and calculate acute group mean averages at week 4.	4 weeks
Acute Salivary Alpha-Amylase Level (In-session Week 8)	Salivary alpha-amylase (sAA) is a biomarker of the autonomic/sympathetic nervous system (ANS/SNS) which may be acutely sensitive to intervention. Secreted sAA levels were measured from saliva samples collected at three time points during intervention sessions (arrival, 20 minutes later, and 40 minutes into the session) to determine a mean sAA level for each participant and calculate acute group mean averages at week 8.	8 weeks
Acute Salivary Uric Acid Level (In-session Week 1)	Salivary Uric Acid (sUA) is a biomarker that may be associated with increases in blood pressure in response to stress and self-perception of power suggesting that sUA may play an important role in self-competence and is thought to contribute to motivation and productivity. Concentration of sUA was measured from saliva collected at one time time point (arrival) prior to intervention session 1. Interpretation of values requires consideration of the context and was collected at Week 1 for exploratory comparison to other variables	1 week
Salivary Uric Acid Level (In-session Week 4)	Salivary Uric Acid (sUA) is a biomarker that may be associated with increases in blood pressure in response to stress and self-perception of power suggesting that sUA may play an important role in self-competence and is thought to contribute to motivation and productivity. Concentration of sUA was measured from saliva collected at one time time point (arrival) prior to intervention session 1. Interpretation of values requires consideration of the context and was collected at Week 4 for exploratory comparison to other variables	4 weeks
Salivary Uric Acid Level (In-session Week 8)	Salivary Uric Acid (sUA) is a biomarker that may be associated with increases in blood pressure in response to stress and self-perception of power suggesting that sUA may play an important role in self-competence and is thought to contribute to motivation and productivity. Concentration of sUA was measured from saliva collected at one time time point (arrival) prior to intervention session 1. Interpretation of values requires consideration of the context and was collected at Week 8 for exploratory comparison to other variables	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Observation of Human-Animal Interaction for Research Coding System (OHAIRE)	Systematic coding of child-animal interaction captured by digital video recording	1 week
Observation of Human-Animal Interaction for Research Coding System (OHAIRE)	Systematic coding of child-animal interaction captured by digital video recording	4 weeks
Observation of Human-Animal Interaction for Research Coding System (OHAIRE)	Systematic coding of child-animal interaction captured by digital video recording	8 weeks
Observation of in-Vivo Pro-social Behavior	Systematic coding of child-child interaction captured by digital video recording	1 week
Observation of in-Vivo Pro-social Behavior	Systematic coding of child-child interaction captured by digital video recording	4 weeks
Observation of in-Vivo Pro-social Behavior	Systematic coding of child-child interaction captured by digital video recording	8 weeks

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Sabrina EB Schuck, Ph.D., University of California, Irvine

Publications and helpful links

General Publications

• Schuck SEB, Zeiler CN, Stehli A, Steinhoff LA, Stokes RY, Jeffrey SE, Granger DA. Acute salivary cortisol response in children with ADHD during psychosocial intervention with and without therapy dogs. Front Psychiatry. 2024 Oct 24;15:1476522. doi: 10.3389/fpsyt.2024.1476522. eCollection 2024.

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2021
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: October 8, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): November 1, 2021

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Social Skills Training; Animal Assisted Intervention
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: 20206069; R21HD103422 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No