Animal Assisted Intervention for Attention Deficit Hyperactivity Disorder (ADHD)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of California, Irvine, Irvine, CAAttention Deficit Hyperactivity Disorder (ADHD)Animal Assisted Intervention - Behavioral
Eligibility
7 - 9
All Sexes
What conditions do you have?
Select

Study Summary

This trialis studying a new therapy combining dogs and traditional social skills training to help kids with ADHD. It will also look at physiological markers to see if they affect results.

Eligible Conditions
  • Attention Deficit Hyperactivity Disorder (ADHD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

8 Primary · 12 Secondary · Reporting Duration: 8 weeks

8 weeks
Acute Heart Rate Variability
Acute Salivary Alpha-Amylase level
Acute Salivary Cortisol level
Acute Salivary Uric Acid level
Observation of Human-Animal Interaction for Research Coding System (OHAIRE)
Observation of in-Vivo Pro-social Behavior
Week 16
Change from Baseline on the ADHD-Rating Scale (ADHD-RS) at 16 weeks follow-up
Change from Baseline on the Self-Perception Profile for Children (SPPC) at 16 weeks
Change from Baseline on the Social Responsiveness Scale (SRS-2) at 16 weeks
Change from Baseline on the Social Skills Improvement System Rating Scales (SSIS-RS) at 16 weeks
Change in Diurnal Salivary Alpha-Amylase at 16 weeks
Change in Diurnal Salivary Cortisol levels at 16 weeks
Change in Heart Rate Variability at 16 weeks
Change in Salivary Uric Acid at 16 weeks
Week 8
Change from Baseline on the ADHD-Rating Scale (ADHD-RS) at 8 weeks
Change from Baseline on the Self-Perception Profile for Children (SPPC) at 8 weeks
Change from Baseline on the Social Responsiveness Scale (SRS-2) at 8 weeks
Change from Baseline on the Social Skills Improvement System Rating Scales (SSIS-RS) at 8 weeks
Change in Diurnal Salivary Alpha-Amylase at 8 weeks
Change in Diurnal Salivary Cortisol levels at 8 weeks
Change in Heart Rate Variability at 8 weeks
Change in Salivary Uric Acid at 8 weeks

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Psychosocial Treatment as Usual
1 of 2
Animal Assisted Intervention
1 of 2

Active Control

Experimental Treatment

52 Total Participants · 2 Treatment Groups

Primary Treatment: Animal Assisted Intervention · No Placebo Group · N/A

Animal Assisted Intervention
Behavioral
Experimental Group · 1 Intervention: Animal Assisted Intervention · Intervention Types: Behavioral
Psychosocial Treatment as Usual
Behavioral
ActiveComparator Group · 1 Intervention: Behavioral Social Skills Training · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Animal Assisted Intervention
2016
N/A
~600

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks

Who is running the clinical trial?

University of California, IrvineLead Sponsor
503 Previous Clinical Trials
1,881,609 Total Patients Enrolled
4 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
218 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Sabrina EB Schuck, Ph.D.Principal InvestigatorUniversity of California, Irvine

Eligibility Criteria

Age 7 - 9 · All Participants · 2 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
California77.8%
Illinois11.1%
Georgia11.1%
How old are they?
18 - 65100.0%
What site did they apply to?
University of California, Irvine100.0%
What portion of applicants met pre-screening criteria?
Met criteria77.8%
Did not meet criteria22.2%

How responsive is this trial?

Typically responds via
Email100.0%

Frequently Asked Questions

Does this research endeavor accept individuals over two decades of age?

"This trial seeks participants who are between the ages of 7 and 9. In addition, there are 109 studies for children under 18 and 38 additional trials involving patients over 65 years old." - Anonymous Online Contributor

Unverified Answer

What is the total number of participants recruited for this experiment?

"That is right. According to the information published on clinicaltrials.gov, this medical experiment has been recruiting since September 17th 2021 and was most recently updated November 30th 2022. The trial requires a total of 52 participants across one particular site." - Anonymous Online Contributor

Unverified Answer

Are individuals currently being sought to partake in this scientific experiment?

"Yes, according to the information shared on clinicaltrials.gov, this trial is still recruiting participants who meet its criteria. The study was launched September 17th 2021 and most recently updated November 30th 2022; it seeks 52 volunteers from one site." - Anonymous Online Contributor

Unverified Answer

What is the overarching aim of this research endeavor?

"This study's primary goal is to assess the Change from Baseline on the Social Responsiveness Scale (SRS-2) at 8 weeks. Secondary objectives include gauging changes in Diurnal Salivary Cortisol levels as an indicator of Hypothalamic Pituitary-Adrenal Axis activity, evaluating alterations in Salivary Uric Acid which functions as a potential bio-marker for disruptive behavior, and determining variations in Diurnal Salivary Alpha-Amylase that could provide insight into Autonomic Nervous System activity over 16 week period." - Anonymous Online Contributor

Unverified Answer

Am I eligible to be one of the test subjects in this clinical experiment?

"This clinical trial is inviting 52 children aged between 7 and 9 that have been medically diagnosed with attention deficit hyperactivity disorder (ADHD). Further requirements include meeting criteria for a diagnosis of ADHD on the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) scale, as well as having no prior exposure to stimulant medication or completing at least 6 weeks without taking any stimulants following enrolment in this study." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.