Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Animal Assisted Intervention With Dogs for Children With ADHD (PACK-PM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05102344
Recruitment Status : Recruiting
First Posted : November 1, 2021
Last Update Posted : November 1, 2021
Sponsor:
Information provided by (Responsible Party):
Sabrina E. Brierley Schuck, Ph.D., University of California, Irvine

Brief 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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Behavioral: Behavioral Social Skills Training Behavioral: Animal Assisted Intervention Not Applicable

Detailed Description:
Attention-Deficit/Hyperactivity Disorder (ADHD) is the most commonly occurring neurodevelopmental disorder in the United States, with current prevalence rates between 8% and 11%, up from an estimated 5% in 2003. Despite decades of research, individuals with ADHD continue to be at significantly greater risk for poor life outcomes compared to non-affect peers. Evidence-based interventions for ADHD include stimulant medications and psychosocial treatments, but these practices are not always feasible or acceptable due to adverse side-effects, cost, availability, and poor treatment adherence. ADHD is considered to be a result of a physiological disruption of select catecholaminergic systems (e.g. dopamine and norepinephrine) and related under-arousal of cognitive functions of the pre-frontal cortex involved in executive functioning (EF). Research indicates that AAI with dogs is effective for improving social-behavioral outcomes related to EF deficits. The mechanisms by which AAI improves outcomes for this group and mediators of these outcomes, however, is not yet understood. These gaps in understanding hinder progress in the application of AAI, limiting the acceptability and availability of this integrative health care practice. Recent research in other populations suggests that AAI acts on hypothalamic-pituitary-adrenal (HPA) axis activity, reducing physiological stress Children with ADHD, however, present with different Autonomic Nervous System (ANS) response patterns when compared to typically developing children and children with other mental health disorders and this phenomenon points to altered physiological activity in response to stress, social feedback, and emotional stimuli when compared to their peers. The bio-social mechanistic hypothesis proposed in this study contends that dogs may elicit physiological responses related to cognitive arousal of EF systems, thereby enhancing response to treatment in children with ADHD. Furthermore, given the heterogeneity of impairment and high comorbidity with other mental health disorders among children with ADHD and the prevalence of ADHD across cultures, race and ethnicity, individual differences in response to AAI and in child/animal interaction may potentially mediate response to AAI. This research will explore these gaps by: 1) replicating findings from a previous AAI RCT on social-behavioral outcomes, 2) exploring candidate physiological responses to AAI over time, and 3) ascertaining if individual differences during AAI mediate primary and/or exploratory main outcomes. This study hypothesizes AAI will result in enhanced social-behavioral outcomes and improved diurnal patterns of HPA and ANS for these children. Furthermore, it is suspected acute physiological responses to AAI (markers of HPA & ANS) and social interaction quality (child/child and child/dog) will mediate main outcomes. To explore these hypotheses, the investigators will conduct an exploratory parallel-group randomized controlled clinical trial with 48 young children with ADHD, participating in psychosocial intervention with or without AAI using a previously manualized AAI model developed and found successful in prior work. This work will yield the first information on candidate mechanisms thought to play an important role in AAI for children with ADHD, thus laying foundations for later submission of a fully powered, multi-site randomized clinical trial aimed to better inform approaches refined for this group, and promote acceptability and generalizability of AAI with children with special needs.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Lab assistants responsible for processing biological samples of interest and the principal statistician are blind to identifying participant information and group assignment.
Primary Purpose: Treatment
Official Title: Animal Assisted Intervention With Dogs for Children With Attention Deficit/Hyperactivity Disorder; Exploring Candidate Physiological Markers of Response to AAI
Actual Study Start Date : September 17, 2021
Estimated Primary Completion Date : July 30, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Psychosocial Treatment as Usual
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
Behavioral: Behavioral Social Skills Training
Behavioral Social Skills Training treatment as usual will include small group semi-structured play, didactic instruction and role-play of basic social skills, including assertion, ignoring provocation, accepting consequences, problem solving, following directions, and self-regulation.

Experimental: Animal Assisted 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
Behavioral: Animal Assisted Intervention
Behavioral Social Skills Training treatment as usual will include small group semi-structured play, didactic instruction and role-play of basic social skills, including assertion, ignoring provocation, accepting consequences, problem solving, following directions, and self-regulation accompanied by trained therapy dogs




Primary Outcome Measures :
  1. Change from Baseline on the ADHD-Rating Scale (ADHD-RS) at 8 weeks [ Time Frame: Change from Baseline at 8 weeks ]
    Categorical and dimensional parent and teacher ratings of symptoms of inattention, hyperactivity, and impulsivity (lowered scores indicate improvement).

  2. Change from Baseline on the ADHD-Rating Scale (ADHD-RS) at 16 weeks follow-up [ Time Frame: Change from Baseline at 16 weeks ]
    Categorical and dimensional parent and teacher ratings of symptoms of inattention, hyperactivity, and impulsivity (lowered scores indicate improvement)

  3. Change from Baseline on the Self-Perception Profile for Children (SPPC) at 8 weeks [ Time Frame: Change from Baseline at 8 weeks ]
    Dimensional self-report ratings of child self-perception (higher scores indicate improvement)

  4. Change from Baseline on the Self-Perception Profile for Children (SPPC) at 16 weeks [ Time Frame: Change from Baseline at 16 weeks ]
    Dimensional self-report ratings of child self-perception (higher scores indicate improvement)

  5. Change from Baseline on the Social Responsiveness Scale (SRS-2) at 8 weeks [ Time Frame: Change from Baseline at 8 weeks ]
    Categorical parent ratings of child social response styles (lower scores indicate improvement)

  6. Change from Baseline on the Social Responsiveness Scale (SRS-2) at 16 weeks [ Time Frame: Change from Baseline at 16 weeks ]
    Categorical parent ratings of child social response styles (lower scores indicate improvement)

  7. Change from Baseline on the Social Skills Improvement System Rating Scales (SSIS-RS) at 8 weeks [ Time Frame: Change from Baseline at 8 weeks ]
    Categorical parent ratings of child social skills (higher scores indicate improvement) and problem behaviors (lower scores indicate improvement)

  8. Change from Baseline on the Social Skills Improvement System Rating Scales (SSIS-RS) at 16 weeks [ Time Frame: Change from Baseline at 16 weeks ]
    Categorical parent ratings of child social skills (higher scores indicate improvement) and problem behaviors (lower scores indicate improvement)


Secondary Outcome Measures :
  1. Change in Diurnal Salivary Cortisol levels at 8 weeks [ Time Frame: Change from Baseline at 8 weeks ]
    Salivary analyte as a bio-marker for Hypothalamic Pituitary-Adrenal Axis activity (lower levels indicate improvement)

  2. Change in Diurnal Salivary Cortisol levels at 16 weeks [ Time Frame: Change from Baseline at 16 weeks ]
    Salivary analyte as a bio-marker for Hypothalamic Pituitary-Adrenal Axis activity (lower levels indicate improvement)

  3. Acute Salivary Cortisol level [ Time Frame: 1 week ]
    Salivary analyte as a bio-marker for Hypothalamic Pituitary-Adrenal Axis activity (lower levels indicate improvement)

  4. Acute Salivary Cortisol level [ Time Frame: 4 weeks ]
    Salivary analyte as a bio-marker for Hypothalamic Pituitary-Adrenal Axis activity (lower levels indicate improvement)

  5. Acute Salivary Cortisol level [ Time Frame: 8 weeks ]
    Salivary analyte as a bio-marker for Hypothalamic Pituitary-Adrenal Axis activity (lower levels indicate improvement)

  6. Change in Diurnal Salivary Alpha-Amylase at 8 weeks [ Time Frame: Change from Baseline at 8 weeks ]
    Salivary analyte as a bio-marker for Autonomic Nervous System activity (interpretation dependent on baseline levels)

  7. Change in Diurnal Salivary Alpha-Amylase at 16 weeks [ Time Frame: Change from Baseline at 16 weeks ]
    Salivary analyte as a bio-marker for Autonomic Nervous System activity (interpretation dependent on baseline levels)

  8. Acute Salivary Alpha-Amylase level [ Time Frame: 1 week ]
    Salivary analyte as a bio-marker for Autonomic Nervous System activity (interpretation dependent on baseline levels)

  9. Acute Salivary Alpha-Amylase level [ Time Frame: 4 weeks ]
    Salivary analyte as a bio-marker for Autonomic Nervous System activity (interpretation dependent on baseline levels)

  10. Acute Salivary Alpha-Amylase level [ Time Frame: 8 weeks ]
    Salivary analyte as a bio-marker for Autonomic Nervous System activity (interpretation dependent on baseline levels)

  11. Change in Salivary Uric Acid at 8 weeks [ Time Frame: Change from Baseline at 8 weeks ]
    Salivary analyte as a candidate bio-marker for disruptive behavior (lower levels indicate improvement)

  12. Change in Salivary Uric Acid at 16 weeks [ Time Frame: Change from Baseline at 16 weeks ]
    Salivary analyte as a candidate bio-marker for disruptive behavior (lower levels indicate improvement)

  13. Acute Salivary Uric Acid level [ Time Frame: 1 week ]
    Salivary analyte as a candidate bio-marker for disruptive behavior (lower levels indicate improvement)

  14. Acute Salivary Uric Acid level [ Time Frame: 4 weeks ]
    Salivary analyte as a candidate bio-marker for disruptive behavior (lower levels indicate improvement)

  15. Acute Salivary Uric Acid level [ Time Frame: 8 weeks ]
    Salivary analyte as a candidate bio-marker for disruptive behavior (lower levels indicate improvement)

  16. Change in Heart Rate Variability at 8 weeks [ Time Frame: Change from Baseline at 8 weeks ]
    Bio-marker for Autonomic Nervous System activity (increased HRV indicates improvement)

  17. Change in Heart Rate Variability at 16 weeks [ Time Frame: Change from Baseline at 16 weeks ]
    Bio-marker for Autonomic Nervous System activity (increased HRV indicates improvement)

  18. Acute Heart Rate Variability [ Time Frame: 1 week ]
    Bio-marker for Autonomic Nervous System activity (increased HRV indicates improvement)

  19. Acute Heart Rate Variability [ Time Frame: 4 weeks ]
    Bio-marker for Autonomic Nervous System activity (increased HRV indicates improvement)

  20. Acute Heart Rate Variability [ Time Frame: 8 weeks ]
    Bio-marker for Autonomic Nervous System activity (increased HRV indicates improvement)


Other Outcome Measures:
  1. Observation of Human-Animal Interaction for Research Coding System (OHAIRE) [ Time Frame: 1 week ]
    Systematic coding of child-animal interaction captured by digital video recording

  2. Observation of Human-Animal Interaction for Research Coding System (OHAIRE) [ Time Frame: 4 weeks ]
    Systematic coding of child-animal interaction captured by digital video recording

  3. Observation of Human-Animal Interaction for Research Coding System (OHAIRE) [ Time Frame: 8 weeks ]
    Systematic coding of child-animal interaction captured by digital video recording

  4. Observation of in-Vivo Pro-social Behavior [ Time Frame: 1 week ]
    Systematic coding of child-child interaction captured by digital video recording

  5. Observation of in-Vivo Pro-social Behavior [ Time Frame: 4 weeks ]
    Systematic coding of child-child interaction captured by digital video recording

  6. Observation of in-Vivo Pro-social Behavior [ Time Frame: 8 weeks ]
    Systematic coding of child-child interaction captured by digital video recording



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 SRS-2 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05102344


Contacts
Layout table for location contacts
Contact: Sabrina EB Schuck, Ph.D. 949-533-5465 sabrina@hs.uci.edu
Contact: Rachel Y Stokes, B.A. (949) 824-1818 rstokes@hs.uci.edu

Locations
Layout table for location information
United States, California
University of California, Irvine Recruiting
Irvine, California, United States, 92697
Contact: Sabrina EB Schuck, Ph.D.    949-533-5465    sabrina@hs.uci.edu   
Contact: Rachel Y Stokes, B.A.    949-824-1818    rstokes@hs.uci.edu   
Principal Investigator: Sabrina EB Schuck, Ph.D.         
Sponsors and Collaborators
University of California, Irvine
Investigators
Layout table for investigator information
Principal Investigator: Sabrina EB Schuck, Ph.D. University of California, Irvine
  Study Documents (Full-Text)

Documents provided by Sabrina E. Brierley Schuck, Ph.D., University of California, Irvine:
Informed Consent Form  [PDF] August 27, 2021

Layout table for additonal information
Responsible Party: Sabrina E. Brierley Schuck, Ph.D., Assistant Professor in Residence, University of California, Irvine
ClinicalTrials.gov Identifier: NCT05102344    
Other Study ID Numbers: UCaliforniaIrvine
First Posted: November 1, 2021    Key Record Dates
Last Update Posted: November 1, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sabrina E. Brierley Schuck, Ph.D., University of California, Irvine:
Animal Assisted Intervention
Social Skills Training
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases