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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Social Skills Training
Animal Assisted Intervention
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Animal Assisted Intervention, Social Skills Training

Eligibility Criteria

7 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California, IrvineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Psychosocial Treatment as Usual

Animal Assisted Intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from Baseline on the ADHD-Rating Scale (ADHD-RS) at 8 weeks
Categorical and dimensional parent and teacher ratings of symptoms of inattention, hyperactivity, and impulsivity (lowered scores indicate improvement).
Change from Baseline on the ADHD-Rating Scale (ADHD-RS) at 16 weeks follow-up
Categorical and dimensional parent and teacher ratings of symptoms of inattention, hyperactivity, and impulsivity (lowered scores indicate improvement)
Change from Baseline on the Self-Perception Profile for Children (SPPC) at 8 weeks
Dimensional self-report ratings of child self-perception (higher scores indicate improvement)
Change from Baseline on the Self-Perception Profile for Children (SPPC) at 16 weeks
Dimensional self-report ratings of child self-perception (higher scores indicate improvement)
Change from Baseline on the Social Responsiveness Scale (SRS-2) at 8 weeks
Categorical parent ratings of child social response styles (lower scores indicate improvement)
Change from Baseline on the Social Responsiveness Scale (SRS-2) at 16 weeks
Categorical parent ratings of child social response styles (lower scores indicate improvement)
Change from Baseline on the Social Skills Improvement System Rating Scales (SSIS-RS) at 8 weeks
Categorical parent ratings of child social skills (higher scores indicate improvement) and problem behaviors (lower scores indicate improvement)
Change from Baseline on the Social Skills Improvement System Rating Scales (SSIS-RS) at 16 weeks
Categorical parent ratings of child social skills (higher scores indicate improvement) and problem behaviors (lower scores indicate improvement)

Secondary Outcome Measures

Change in Diurnal Salivary Cortisol levels at 8 weeks
Salivary analyte as a bio-marker for Hypothalamic Pituitary-Adrenal Axis activity (lower levels indicate improvement)
Change in Diurnal Salivary Cortisol levels at 16 weeks
Salivary analyte as a bio-marker for Hypothalamic Pituitary-Adrenal Axis activity (lower levels indicate improvement)
Acute Salivary Cortisol level
Salivary analyte as a bio-marker for Hypothalamic Pituitary-Adrenal Axis activity (lower levels indicate improvement)
Acute Salivary Cortisol level
Salivary analyte as a bio-marker for Hypothalamic Pituitary-Adrenal Axis activity (lower levels indicate improvement)
Acute Salivary Cortisol level
Salivary analyte as a bio-marker for Hypothalamic Pituitary-Adrenal Axis activity (lower levels indicate improvement)
Change in Diurnal Salivary Alpha-Amylase at 8 weeks
Salivary analyte as a bio-marker for Autonomic Nervous System activity (interpretation dependent on baseline levels)
Change in Diurnal Salivary Alpha-Amylase at 16 weeks
Salivary analyte as a bio-marker for Autonomic Nervous System activity (interpretation dependent on baseline levels)
Acute Salivary Alpha-Amylase level
Salivary analyte as a bio-marker for Autonomic Nervous System activity (interpretation dependent on baseline levels)
Acute Salivary Alpha-Amylase level
Salivary analyte as a bio-marker for Autonomic Nervous System activity (interpretation dependent on baseline levels)
Acute Salivary Alpha-Amylase level
Salivary analyte as a bio-marker for Autonomic Nervous System activity (interpretation dependent on baseline levels)
Change in Salivary Uric Acid at 8 weeks
Salivary analyte as a candidate bio-marker for disruptive behavior (lower levels indicate improvement)
Change in Salivary Uric Acid at 16 weeks
Salivary analyte as a candidate bio-marker for disruptive behavior (lower levels indicate improvement)
Acute Salivary Uric Acid level
Salivary analyte as a candidate bio-marker for disruptive behavior (lower levels indicate improvement)
Acute Salivary Uric Acid level
Salivary analyte as a candidate bio-marker for disruptive behavior (lower levels indicate improvement)
Acute Salivary Uric Acid level
Salivary analyte as a candidate bio-marker for disruptive behavior (lower levels indicate improvement)
Change in Heart Rate Variability at 8 weeks
Bio-marker for Autonomic Nervous System activity (increased HRV indicates improvement)
Change in Heart Rate Variability at 16 weeks
Bio-marker for Autonomic Nervous System activity (increased HRV indicates improvement)
Acute Heart Rate Variability
Bio-marker for Autonomic Nervous System activity (increased HRV indicates improvement)
Acute Heart Rate Variability
Bio-marker for Autonomic Nervous System activity (increased HRV indicates improvement)
Acute Heart Rate Variability
Bio-marker for Autonomic Nervous System activity (increased HRV indicates improvement)

Full Information

First Posted
October 8, 2021
Last Updated
November 30, 2022
Sponsor
University of California, Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT05102344
Brief Title
Animal Assisted Intervention With Dogs for Children With ADHD
Acronym
PACK-PM
Official Title
Animal Assisted Intervention With Dogs for Children With Attention Deficit/Hyperactivity Disorder; Exploring Candidate Physiological Markers of Response to AAI
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 17, 2021 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Animal Assisted Intervention, Social Skills Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psychosocial Treatment as Usual
Arm Type
Active Comparator
Arm Description
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
Arm Title
Animal Assisted Intervention
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Social Skills Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Animal Assisted Intervention
Intervention Description
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 Measure Information:
Title
Change from Baseline on the ADHD-Rating Scale (ADHD-RS) at 8 weeks
Description
Categorical and dimensional parent and teacher ratings of symptoms of inattention, hyperactivity, and impulsivity (lowered scores indicate improvement).
Time Frame
Change from Baseline at 8 weeks
Title
Change from Baseline on the ADHD-Rating Scale (ADHD-RS) at 16 weeks follow-up
Description
Categorical and dimensional parent and teacher ratings of symptoms of inattention, hyperactivity, and impulsivity (lowered scores indicate improvement)
Time Frame
Change from Baseline at 16 weeks
Title
Change from Baseline on the Self-Perception Profile for Children (SPPC) at 8 weeks
Description
Dimensional self-report ratings of child self-perception (higher scores indicate improvement)
Time Frame
Change from Baseline at 8 weeks
Title
Change from Baseline on the Self-Perception Profile for Children (SPPC) at 16 weeks
Description
Dimensional self-report ratings of child self-perception (higher scores indicate improvement)
Time Frame
Change from Baseline at 16 weeks
Title
Change from Baseline on the Social Responsiveness Scale (SRS-2) at 8 weeks
Description
Categorical parent ratings of child social response styles (lower scores indicate improvement)
Time Frame
Change from Baseline at 8 weeks
Title
Change from Baseline on the Social Responsiveness Scale (SRS-2) at 16 weeks
Description
Categorical parent ratings of child social response styles (lower scores indicate improvement)
Time Frame
Change from Baseline at 16 weeks
Title
Change from Baseline on the Social Skills Improvement System Rating Scales (SSIS-RS) at 8 weeks
Description
Categorical parent ratings of child social skills (higher scores indicate improvement) and problem behaviors (lower scores indicate improvement)
Time Frame
Change from Baseline at 8 weeks
Title
Change from Baseline on the Social Skills Improvement System Rating Scales (SSIS-RS) at 16 weeks
Description
Categorical parent ratings of child social skills (higher scores indicate improvement) and problem behaviors (lower scores indicate improvement)
Time Frame
Change from Baseline at 16 weeks
Secondary Outcome Measure Information:
Title
Change in Diurnal Salivary Cortisol levels at 8 weeks
Description
Salivary analyte as a bio-marker for Hypothalamic Pituitary-Adrenal Axis activity (lower levels indicate improvement)
Time Frame
Change from Baseline at 8 weeks
Title
Change in Diurnal Salivary Cortisol levels at 16 weeks
Description
Salivary analyte as a bio-marker for Hypothalamic Pituitary-Adrenal Axis activity (lower levels indicate improvement)
Time Frame
Change from Baseline at 16 weeks
Title
Acute Salivary Cortisol level
Description
Salivary analyte as a bio-marker for Hypothalamic Pituitary-Adrenal Axis activity (lower levels indicate improvement)
Time Frame
1 week
Title
Acute Salivary Cortisol level
Description
Salivary analyte as a bio-marker for Hypothalamic Pituitary-Adrenal Axis activity (lower levels indicate improvement)
Time Frame
4 weeks
Title
Acute Salivary Cortisol level
Description
Salivary analyte as a bio-marker for Hypothalamic Pituitary-Adrenal Axis activity (lower levels indicate improvement)
Time Frame
8 weeks
Title
Change in Diurnal Salivary Alpha-Amylase at 8 weeks
Description
Salivary analyte as a bio-marker for Autonomic Nervous System activity (interpretation dependent on baseline levels)
Time Frame
Change from Baseline at 8 weeks
Title
Change in Diurnal Salivary Alpha-Amylase at 16 weeks
Description
Salivary analyte as a bio-marker for Autonomic Nervous System activity (interpretation dependent on baseline levels)
Time Frame
Change from Baseline at 16 weeks
Title
Acute Salivary Alpha-Amylase level
Description
Salivary analyte as a bio-marker for Autonomic Nervous System activity (interpretation dependent on baseline levels)
Time Frame
1 week
Title
Acute Salivary Alpha-Amylase level
Description
Salivary analyte as a bio-marker for Autonomic Nervous System activity (interpretation dependent on baseline levels)
Time Frame
4 weeks
Title
Acute Salivary Alpha-Amylase level
Description
Salivary analyte as a bio-marker for Autonomic Nervous System activity (interpretation dependent on baseline levels)
Time Frame
8 weeks
Title
Change in Salivary Uric Acid at 8 weeks
Description
Salivary analyte as a candidate bio-marker for disruptive behavior (lower levels indicate improvement)
Time Frame
Change from Baseline at 8 weeks
Title
Change in Salivary Uric Acid at 16 weeks
Description
Salivary analyte as a candidate bio-marker for disruptive behavior (lower levels indicate improvement)
Time Frame
Change from Baseline at 16 weeks
Title
Acute Salivary Uric Acid level
Description
Salivary analyte as a candidate bio-marker for disruptive behavior (lower levels indicate improvement)
Time Frame
1 week
Title
Acute Salivary Uric Acid level
Description
Salivary analyte as a candidate bio-marker for disruptive behavior (lower levels indicate improvement)
Time Frame
4 weeks
Title
Acute Salivary Uric Acid level
Description
Salivary analyte as a candidate bio-marker for disruptive behavior (lower levels indicate improvement)
Time Frame
8 weeks
Title
Change in Heart Rate Variability at 8 weeks
Description
Bio-marker for Autonomic Nervous System activity (increased HRV indicates improvement)
Time Frame
Change from Baseline at 8 weeks
Title
Change in Heart Rate Variability at 16 weeks
Description
Bio-marker for Autonomic Nervous System activity (increased HRV indicates improvement)
Time Frame
Change from Baseline at 16 weeks
Title
Acute Heart Rate Variability
Description
Bio-marker for Autonomic Nervous System activity (increased HRV indicates improvement)
Time Frame
1 week
Title
Acute Heart Rate Variability
Description
Bio-marker for Autonomic Nervous System activity (increased HRV indicates improvement)
Time Frame
4 weeks
Title
Acute Heart Rate Variability
Description
Bio-marker for Autonomic Nervous System activity (increased HRV indicates improvement)
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Observation of Human-Animal Interaction for Research Coding System (OHAIRE)
Description
Systematic coding of child-animal interaction captured by digital video recording
Time Frame
1 week
Title
Observation of Human-Animal Interaction for Research Coding System (OHAIRE)
Description
Systematic coding of child-animal interaction captured by digital video recording
Time Frame
4 weeks
Title
Observation of Human-Animal Interaction for Research Coding System (OHAIRE)
Description
Systematic coding of child-animal interaction captured by digital video recording
Time Frame
8 weeks
Title
Observation of in-Vivo Pro-social Behavior
Description
Systematic coding of child-child interaction captured by digital video recording
Time Frame
1 week
Title
Observation of in-Vivo Pro-social Behavior
Description
Systematic coding of child-child interaction captured by digital video recording
Time Frame
4 weeks
Title
Observation of in-Vivo Pro-social Behavior
Description
Systematic coding of child-child interaction captured by digital video recording
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabrina EB Schuck, Ph.D.
Phone
949-533-5465
Email
sabrina@hs.uci.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel Y Stokes, B.A.
Phone
(949) 824-1818
Email
rstokes@hs.uci.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabrina EB Schuck, Ph.D.
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabrina EB Schuck, Ph.D.
Phone
949-533-5465
Email
sabrina@hs.uci.edu
First Name & Middle Initial & Last Name & Degree
Rachel Y Stokes, B.A.
Phone
949-824-1818
Email
rstokes@hs.uci.edu
First Name & Middle Initial & Last Name & Degree
Sabrina EB Schuck, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Animal Assisted Intervention With Dogs for Children With ADHD

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