What side effects are associated with this type of intervention?

Non-pharmacological psychosocial interventions for ADHD, such as Animal Assisted Intervention (AAI) with therapy dogs combined with traditional social skills training, generally have minimal side effects compared to pharmacological treatments. Potential side effects may include mild allergic reactions to animals, anxiety or discomfort around animals, and the possibility of minor injuries (e.g., scratches or bites). Additionally, there may be variability in individual responses, with some children experiencing limited improvement in ADHD symptoms. Overall, these interventions are considered safe and well-tolerated, with the primary focus on enhancing social skills and reducing stress.

What prior FDA approvals exist?

The FDA has approved several pharmacological treatments for ADHD, including stimulants such as methylphenidate and amphetamines, non-stimulants like atomoxetine, and alpha-2 adrenergic agonists such as clonidine and guanfacine. While these medications are effective in managing ADHD symptoms, non-pharmacological psychosocial interventions, such as cognitive-behavioral therapy (CBT) and social skills training, are also commonly used. These interventions aim to improve social skills and manage behavioral issues, similar to the goals of the Animal Assisted Intervention (AAI) with therapy dogs combined with traditional social skills training being studied.

What other types of research exist?

Promising, novel alternatives to Animal Assisted Intervention (AAI) with therapy dogs for ADHD patients include: 1) Mindfulness-based interventions, which have shown benefits in improving quality of life and coping strategies. 2) Neurofeedback, which has been used to improve attention and reduce hyperactivity. 3) Cognitive-behavioral therapy (CBT) focused on social skills training. 4) Computer-based cognitive remediation programs that enhance cognitive functions and social skills. These interventions can be considered as complementary or standalone treatments depending on individual patient needs.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

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 more

Secondary study objectives

Acute Heart Rate Variability

Acute Salivary Alpha-Amylase level

Acute Salivary Cortisol level

+9 more

Other 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

Do I qualify?Apply below to find out

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.