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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 change from baseline at 8 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if therapy dogs combined with social skills training can help children with ADHD. These children often struggle with standard treatments. The therapy dogs might reduce stress and improve social behaviors by affecting certain body systems.
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSecondary study objectives
Acute Heart Rate Variability
Acute Salivary Alpha-Amylase level
Acute Salivary Cortisol level
+9 moreOther study objectives
Observation of Human-Animal Interaction for Research Coding System (OHAIRE)
Observation of in-Vivo Pro-social Behavior
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Non-pharmacological psychosocial interventions for ADHD, such as Animal Assisted Intervention (AAI) with therapy dogs combined with traditional social skills training, work by enhancing social skills and potentially reducing physiological stress markers like those related to the HPA axis and ANS activity. These interventions provide structured social interactions and emotional support, which can help children with ADHD develop better social behaviors and coping mechanisms.
This is crucial for ADHD patients as it addresses core symptoms like impulsivity and social difficulties without the side effects associated with pharmacological treatments. Additionally, other common treatments include behavioral therapy, which focuses on modifying negative behaviors through reinforcement strategies, and cognitive-behavioral therapy (CBT), which helps patients develop better organizational and problem-solving skills.
These therapies are important as they offer holistic approaches to managing ADHD symptoms, improving overall quality of life.
Non-Pharmacological Treatments for ADHD in Youth.Attention Deficit Hyperactivity Disorder in Preschool-Age Children.
Non-Pharmacological Treatments for ADHD in Youth.Attention Deficit Hyperactivity Disorder in Preschool-Age Children.
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Who is running the clinical trial?
University of California, IrvineLead Sponsor
560 Previous Clinical Trials
1,930,060 Total Patients Enrolled
6 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
829 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Sabrina EB Schuck, Ph.D.Principal InvestigatorUniversity of California, Irvine
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with ADHD using the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS).You have been diagnosed with Autism Spectrum Disorder and have very high scores on specific tests.You are allergic to dogs.You are very scared of dogs.This criterion states that individuals with a history of being cruel to animals or having family members with such a history will not be included in the study.You have been diagnosed with schizophrenia according to specific research criteria.You have been diagnosed with Major Depressive Disorder using a specific assessment tool called K-SADS.
Research Study Groups:
This trial has the following groups:- Group 1: Psychosocial Treatment as Usual
- Group 2: Animal Assisted Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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