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Animal Assisted Therapy for ADHD (PACK-PM Trial)

N/A
Waitlist Available
Led By Sabrina EB Schuck, Ph.D.
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

PACK-PM Trial 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.

Who is the study for?
This trial is for children with ADHD who have been diagnosed using the K-SADS. They should not be on stimulant medication currently or within the last 6 weeks and cannot have a diagnosis of Autism Spectrum Disorder, Major Depressive Disorder, or Schizophrenia. Children with allergies to dogs, significant fear of dogs, or a history of cruelty to animals are excluded.Check my eligibility
What is being tested?
The study compares traditional social skills training alone (TAU) with Animal Assisted Intervention (AAI), where therapy dogs are involved in treatment. It also examines if certain physiological markers related to stress response systems can predict how well children respond to these treatments.See study design
What are the potential side effects?
Since this trial involves behavioral interventions and animal-assisted therapy rather than medications, there are no typical side effects like those seen with drugs. However, participants may experience emotional distress or allergic reactions around animals.

PACK-PM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline on the ADHD-Rating Scale (ADHD-RS) at 16 weeks follow-up
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 16 weeks
+5 more
Secondary outcome measures
Acute Heart Rate Variability
Acute Salivary Alpha-Amylase level
Acute Salivary Cortisol level
+9 more
Other outcome measures
Observation of Human-Animal Interaction for Research Coding System (OHAIRE)
Observation of in-Vivo Pro-social Behavior

PACK-PM Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Animal Assisted InterventionExperimental Treatment1 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
Group II: Psychosocial Treatment as UsualActive Control1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Animal Assisted Intervention
2016
N/A
~640

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor
542 Previous Clinical Trials
1,921,962 Total Patients Enrolled
5 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
718 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Sabrina EB Schuck, Ph.D.Principal InvestigatorUniversity of California, Irvine

Media Library

Animal Assisted Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05102344 — N/A
Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: Psychosocial Treatment as Usual, Animal Assisted Intervention
Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: Animal Assisted Intervention Highlights & Side Effects. Trial Name: NCT05102344 — N/A
Animal Assisted Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05102344 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
Georgia
California
How old are they?
18 - 65
What site did they apply to?
University of California, Irvine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Animal Assisted Intervention With Dogs for Children With ADHD
Sabrina E. Brierley Schuck, Ph.D. 2021. "Animal Assisted Intervention With Dogs for Children With ADHD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05102344.
~11 spots leftby Apr 2025
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