N/A N=39 Randomized Single-blind Treatment

Animal Assisted Intervention With Dogs for Children With ADHD

Attention Deficit Hyperactivity Disorder

Bottom Line

View on ClinicalTrials.gov: NCT05102344 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2025

Primary outcome: Primary: ADHD-Rating Scale (ADHD-RS) at 8 Weeks — 29.0; 23.9 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Behavioral Social Skills Training (Behavioral); Animal Assisted Intervention (Behavioral)
Age: Pediatric · 7+ yrs
Sex: All
Sponsor: University of California, Irvine
Primary completion: Aug 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY ADHD-Rating Scale (ADHD-RS) at 8 Weeks	29.0; 23.9	—
PRIMARY ADHD-Rating Scale (ADHD-RS) at 16 Weeks Follow-up	28.29; 24.26	—
PRIMARY Self-Perception Profile for Children (SPPC) at 8 Weeks	2.981; 3.142	—
PRIMARY Self-Perception Profile for Children (SPPC) at 16 Weeks	2.956; 3.236	—
PRIMARY Social Responsiveness Scale (SRS-2) at 8 Weeks	57.89; 60.80	—
PRIMARY Social Responsiveness Scale (SRS-2) at 16 Weeks	57.16; 58.90	—
PRIMARY Social Skills Improvement System Rating Scales (SSIS-RS) Social Skills at 8 Weeks	90.16; 87.80	—
PRIMARY Social Skills Improvement System Rating Scales (SSIS-RS) Social Skills at 16 Weeks	89.84; 90.10	—
PRIMARY Social Skills Improvement System Rating Scale (SSIS-RS) Problem Behaviors at 8 Weeks	119.53; 117.55	—
PRIMARY Social Skills Improvement System Rating Scale (SSIS-RS) Problem Behaviors at 16 Weeks	117.63; 114.10	—
SECONDARY Diurnal Salivary Cortisol Levels at 8 Weeks	-.1378; -.104	—
SECONDARY Diurnal Salivary Cortisol Levels at 16 Weeks	-.125; -.136	—
SECONDARY Acute Salivary Cortisol Level (In-session Week 1)	.138; .141	—
SECONDARY Acute Salivary Cortisol Level (In-session Week 4)	.103; .102	—
SECONDARY Acute Salivary Cortisol Level (In-session Week 8)	.101; .101	—
SECONDARY Alpha-Amylase From Saliva at 8 Weeks	11.21; 17.21	—
SECONDARY Alpha-Amylase From Saliva at 16 Weeks	5.74; 13.37	—
SECONDARY Acute Salivary Alpha-Amylase Level (In-session Week 1)	88.45; 88.93	—
SECONDARY Acute Salivary Alpha-Amylase Level (In-session Week 4)	77.27; 84.68	—
SECONDARY Acute Salivary Alpha-Amylase Level (In-session Week 8)	78.23; 94.34	—
SECONDARY Acute Salivary Uric Acid Level (In-session Week 1)	2.80; 2.35	—
SECONDARY Salivary Uric Acid Level (In-session Week 4)	2.70; 2.35	—
SECONDARY Salivary Uric Acid Level (In-session Week 8)	2.98; 2.21	—

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.

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05102344). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.