Attention Deficit Hyperactivity Disorder
Conditions
Keywords
Animal Assisted Intervention, Social Skills Training
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 Randomized Controlled Trial 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.
Interventions
BEHAVIORALBehavioral 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.
BEHAVIORALAnimal 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
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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.
Eligibility
Sex/Gender
ALL
Age
7 Years to 9 Years
Healthy volunteers
Yes
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 Autism Specturm Rating Scale (ASRS) 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ADHD-Rating Scale (ADHD-RS) at 8 Weeks | At 8 weeks | Attention Deficit/Hyperactivity Rating Scale for Parents is a categorical and dimensional parent and teacher ratings of symptoms of inattention, hyperactivity, and impulsivity (min: 0.00, max: 54.00; lower scores indicate less impairment). |
| ADHD-Rating Scale (ADHD-RS) at 16 Weeks Follow-up | At 16 weeks | Attention Deficit/Hyperactivity Rating Scale for Parents is a categorical and dimensional parent and teacher ratings of symptoms of inattention, hyperactivity, and impulsivity (min: 0.00, max: 54.00; lower scores indicate less impairment). |
| Self-Perception Profile for Children (SPPC) at 8 Weeks | At 8 weeks | The Self-Perception Profile for Children (SPPC; Harter) uses a 4-point Likert scale, where each item is scored from 1 to 4. The SPPC measures self-perceptions across six domains: Scholastic Competence, Social Acceptance, Athletic Competence, Physical Appearance, Behavioral Conduct, and Global Self-Worth, with a total score summing and averaging 36 items with a total score of 1 being the lowest perceived competence or adequacy, and a score of 4 represents the highest level of competence or adequacy. |
| Self-Perception Profile for Children (SPPC) at 16 Weeks | At 16 weeks | The Self-Perception Profile for Children (SPPC; Harter) uses a 4-point Likert scale, where each item is scored from 1 to 4. The SPPC measures self-perceptions across six domains: Scholastic Competence, Social Acceptance, Athletic Competence, Physical Appearance, Behavioral Conduct, and Global Self-Worth, with a total score summing and averaging 36 items with a total score of 1 being the lowest perceived competence or adequacy, and a score of 4 represents the highest level of competence or adequacy. |
| Social Responsiveness Scale (SRS-2) at 8 Weeks | At 8 weeks | The Social Responsiveness Scale, second edition, (SRS-2: Constantino) measures parent ratings of symptoms of Autism Spectrum Disorder for individuals (preschool to adulthood). It is a 65-item, 4-point Likert rating scale with item scores ranging (1-4). Total scores are summed from 5 sub-scales and transformed to a Total T-score reported above. The population mean for the Total T-score value is 50 with a standard deviation of 10, with scores of 59 and below considered normal, and higher scores indicating a greater likelihood of a clinical diagnosis of ASD. |
| Social Responsiveness Scale (SRS-2) at 16 Weeks | At 16 weeks | The Social Responsiveness Scale, second edition, (SRS-2: Constantino) measures parent ratings of symptoms of Autism Spectrum Disorder for individuals (preschool to adulthood). It is a 65-item, 4-point Likert rating scale with item scores ranging (1-4). Total scores are summed from 5 sub-scales and transformed to a Total T-score reported above. The population mean for the Total T-score value is 50 with a standard deviation of 10, with scores of 59 and below considered normal, and higher scores indicating a greater likelihood of a clinical diagnosis of ASD. |
| Social Skills Improvement System Rating Scales (SSIS-RS) Social Skills at 8 Weeks | At 8 weeks | The Social Skills Improvement System Rating Scales, parent version, social skills sub-scale (SSIS-RS; Gresham) is a norm-referenced rating form used to assess social skills in children and adolescents aged 3-18. The Social Skills sub-scale is composed of 46-items and utilizes a 4-point Likert scale, with item scores ranging from 0-3. The total sub-scale summed score is age-adjusted and scaled scores have a mean of 100 and a standard deviation of 15, with higher scores representing better social skills. |
| Social Skills Improvement System Rating Scales (SSIS-RS) Social Skills at 16 Weeks | At 16 weeks | The Social Skills Improvement System Rating Scales, parent version, social skills sub-scale (SSIS-RS; Gresham) is a norm-referenced rating form used to assess social skills in children and adolescents aged 3-18. The Social Skills sub-scale is composed of 46-items and utilizes a 4-point Likert scale, with item scores ranging from 0-3. The total sub-scale summed score is age-adjusted and scaled scores have a mean of 100 and a standard deviation of 15, with higher scores representing better social skills. |
| Social Skills Improvement System Rating Scale (SSIS-RS) Problem Behaviors at 8 Weeks | At 8 Weeks | The Social Skills Improvement System Rating Scales, parent version, problem behaviors sub-scale (SSIS-RS; Gresham) is a norm-referenced rating form used to assess problem behaviors in children and adolescents aged 3-18. The Problem Behaviors sub-scale is composed of 33-items and utilizes a 4-point Likert scale, with item scores ranging from 0-3. The total sub-scale summed score is age-adjusted and scaled scores have a mean of 100 and a standard deviation of 15, with higher scores representing more problematic behavior. |
| Social Skills Improvement System Rating Scale (SSIS-RS) Problem Behaviors at 16 Weeks | At 16 weeks | The Social Skills Improvement System Rating Scales, parent version, problem behaviors sub-scale (SSIS-RS; Gresham) is a norm-referenced rating form used to assess problem behaviors in children and adolescents aged 3-18. The Problem Behaviors sub-scale is composed of 33-items and utilizes a 4-point Likert scale, with item scores ranging from 0-3. The total sub-scale summed score is age-adjusted and scaled scores have a mean of 100 and a standard deviation of 15, with higher scores representing more problematic behavior. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Salivary Uric Acid Level (In-session Week 1) | 1 week | Salivary Uric Acid (sUA) is a biomarker that may be associated with increases in blood pressure in response to stress and self-perception of power suggesting that sUA may play an important role in self-competence and is thought to contribute to motivation and productivity. Concentration of sUA was measured from saliva collected at one time time point (arrival) prior to intervention session 1. Interpretation of values requires consideration of the context and was collected at Week 1 for exploratory comparison to other variables |
| Diurnal Salivary Cortisol Levels at 8 Weeks | At 8 weeks | Cortisol is a stress-sensitive hormone which follows a diurnal cycle. Diurnal change in cortisol is typically measured as a negative slope value with average scores often around -1.00, with steeper (more negative) scores associated with well-being and flatter diurnal cortisol slopes associated with chronic psychosocial stress and poor outcomes in past theory and research. Secreted cortisol levels were measured from saliva samples were collected at three time points (awakening, morning, bedtime) across two days at the end of the intervention (at 8 weeks from baseline) to calculate end of treatment group mean slopes. |
| Salivary Uric Acid Level (In-session Week 8) | 8 weeks | Salivary Uric Acid (sUA) is a biomarker that may be associated with increases in blood pressure in response to stress and self-perception of power suggesting that sUA may play an important role in self-competence and is thought to contribute to motivation and productivity. Concentration of sUA was measured from saliva collected at one time time point (arrival) prior to intervention session 1. Interpretation of values requires consideration of the context and was collected at Week 8 for exploratory comparison to other variables |
| Salivary Uric Acid Level (In-session Week 4) | 4 weeks | Salivary Uric Acid (sUA) is a biomarker that may be associated with increases in blood pressure in response to stress and self-perception of power suggesting that sUA may play an important role in self-competence and is thought to contribute to motivation and productivity. Concentration of sUA was measured from saliva collected at one time time point (arrival) prior to intervention session 1. Interpretation of values requires consideration of the context and was collected at Week 4 for exploratory comparison to other variables |
| Diurnal Salivary Cortisol Levels at 16 Weeks | At 16 weeks | Cortisol is a stress-sensitive hormone which follows a diurnal cycle. Diurnal change in cortisol is typically measured as a negative slope value with average scores often around -1.00, with steeper (more negative) scores associated with well-being and flatter diurnal cortisol slopes associated with chronic psychosocial stress and poor outcomes in past theory and research. Secreted cortisol levels were measured from saliva samples were collected at three time points (awakening, morning, bedtime) across two days at 8 weeks following end of the intervention (at 16 weeks from baseline) to calculate follow-up group mean slopes. |
| Acute Salivary Cortisol Level (In-session Week 1) | 1 week | Cortisol is a stress-sensitive hormone which may be acutely sensitive to intervention. Secreted cortisol levels were measured from saliva samples collected at three time points during intervention sessions (arrival, 20 minutes later, and 40 minutes into the session) and to determine a mean cortisol level for each participant and calculate acute group mean averages at week 1. |
| Acute Salivary Cortisol Level (In-session Week 4) | 4 weeks | Cortisol is a stress-sensitive hormone which may be acutely sensitive to intervention. Secreted cortisol levels were measured from saliva samples collected at three time points during intervention sessions (arrival, 20 minutes later, and 40 minutes into the session) and to determine a mean cortisol level for each participant and calculate acute group mean averages at week 4. |
| Acute Salivary Cortisol Level (In-session Week 8) | 8 weeks | Cortisol is a stress-sensitive hormone which may be acutely sensitive to intervention. Secreted cortisol levels were measured from saliva samples collected at three time points during intervention sessions (arrival, 20 minutes later, and 40 minutes into the session) and to determine a mean cortisol level for each participant and calculate acute group mean averages at week 8. |
| Alpha-Amylase From Saliva at 8 Weeks | At 8 weeks | Salivary Alpha Amylase (sAA) is an enzyme marker of the autonomic/sympathetic nervous system (ANS/SNS) steadily rises over the day. Diurnal change is measured as a positive slope value. Steeper slope indicates faster increase in sAA levels and has been associated with poor health outcomes. Secreted sAA levels were measured from saliva collected at three time points (awakening, morning, bedtime) over two days before the last intervention intervention session (week 8) to calculate baseline group mean slope. Interpretation of values requires consideration of the context and was collected at 8-weeks for comparison to other variables. |
| Alpha-Amylase From Saliva at 16 Weeks | At 16 weeks | Salivary Alpha Amylase (sAA) is an enzyme marker of the autonomic/sympathetic nervous system (ANS/SNS) steadily rises over the day. Diurnal change is measured as a positive slope value. Steeper slope indicates faster increase in sAA levels and has been associated with poor health outcomes. Secreted sAA levels were measured from saliva collected at three time points (awakening, morning, bedtime) over two days before the follow-up session (week 16, or 8 weeks post-intervention) to calculate baseline group mean slope. Interpretation of values requires consideration of the context and was collected at 16-weeks for comparison to other variables. |
| Acute Salivary Alpha-Amylase Level (In-session Week 1) | 1 week | Salivary alpha-amylase (sAA) is a biomarker of the autonomic/sympathetic nervous system (ANS/SNS) which may be acutely sensitive to intervention. Secreted sAA levels were measured from saliva samples collected at three time points during intervention sessions (arrival, 20 minutes later, and 40 minutes into the session) to determine a mean sAA level for each participant and calculate acute group mean averages at week 1. |
| Acute Salivary Alpha-Amylase Level (In-session Week 4) | 4 weeks | Salivary alpha-amylase (sAA) is a biomarker of the autonomic/sympathetic nervous system (ANS/SNS) which may be acutely sensitive to intervention. Secreted sAA levels were measured from saliva samples collected at three time points during intervention sessions (arrival, 20 minutes later, and 40 minutes into the session) to determine a mean sAA level for each participant and calculate acute group mean averages at week 4. |
| Acute Salivary Alpha-Amylase Level (In-session Week 8) | 8 weeks | Salivary alpha-amylase (sAA) is a biomarker of the autonomic/sympathetic nervous system (ANS/SNS) which may be acutely sensitive to intervention. Secreted sAA levels were measured from saliva samples collected at three time points during intervention sessions (arrival, 20 minutes later, and 40 minutes into the session) to determine a mean sAA level for each participant and calculate acute group mean averages at week 8. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 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. | 19 |
| 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
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 | 20 |
| Total | 39 |
Baseline characteristics
| Characteristic | Animal Assisted Intervention | Total | Psychosocial Treatment as Usual |
|---|---|---|---|
| Age, Categorical <=18 years | 20 Participants | 39 Participants | 19 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 8.207 years | 8.305 years | 8.409 years |
| Attention Deficit Hyperactivity Disorder-Rating Scale | 42.06 units on a scale STANDARD_DEVIATION 7.9 | 41.9 units on a scale STANDARD_DEVIATION 8.2 | 41.84 units on a scale STANDARD_DEVIATION 8.1 |
| Autism Spectrum Rating System (ASRS) | 56.82 units on a scale STANDARD_DEVIATION 9.7 | 57.11 units on a scale STANDARD_DEVIATION 9.6 | 57.37 units on a scale STANDARD_DEVIATION 9.1 |
| Diurnal Salivary Alpha-Amylase at Baseline | 8.1836 u/mL per day STANDARD_DEVIATION 14.83 | 6.63 u/mL per day STANDARD_DEVIATION 14.9 | 4.90406 u/mL per day STANDARD_DEVIATION 14.95 |
| Diurnal Salivary Cortisol Levels at Baseline | -.14196 ug/mL per day STANDARD_DEVIATION 0.07 | -.1408 ug/mL per day STANDARD_DEVIATION 0.06 | -.13959 ug/mL per day STANDARD_DEVIATION 0.06 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 7 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 29 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| National Institutes of Health Toolkit-Flanker Task | 88.68 units on a scale STANDARD_DEVIATION 12.5 | 89.74 units on a scale STANDARD_DEVIATION 11.6 | 90.79 units on a scale STANDARD_DEVIATION 10.7 |
| NIH Toolkit Dimensional Change | 92.21 units on a scale STANDARD_DEVIATION 12.5 | 91.97 units on a scale STANDARD_DEVIATION 12.3 | 91.74 units on a scale STANDARD_DEVIATION 12.1 |
| NIH Toolkit List Sort Task | 96.89 units on a scale STANDARD_DEVIATION 14.9 | 93.7 units on a scale STANDARD_DEVIATION 15.2 | 90.58 units on a scale STANDARD_DEVIATION 16 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) White | 14 Participants | 28 Participants | 14 Participants |
| Region of Enrollment United States | 20 participants | 39 participants | 19 participants |
| Salivary Uric Acid at Baseline | 3.34 mg/dL STANDARD_DEVIATION 2.29 | 3.44 mg/dL STANDARD_DEVIATION 2.4 | 3.51 mg/dL STANDARD_DEVIATION 2.51 |
| Self-Perception Profile for Children (Harter) | 3.08 units on a scale STANDARD_DEVIATION 0.514 | 3.06 units on a scale STANDARD_DEVIATION 0.605 | 3.05 units on a scale STANDARD_DEVIATION 0.601 |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 4 Participants |
| Sex: Female, Male Male | 16 Participants | 31 Participants | 15 Participants |
| Social Responsiveness Scale (SRS-2) | 61.53 T-Score STANDARD_DEVIATION 10.9 | 61.8 T-Score STANDARD_DEVIATION 10.77 | 62.06 T-Score STANDARD_DEVIATION 10.95 |
| Social Skills Improvement System-Problem Behaviors | 122.40 units on a scale STANDARD_DEVIATION 13.89 | 122.49 units on a scale STANDARD_DEVIATION 14.53 | 122.58 units on a scale STANDARD_DEVIATION 15.56 |
| Social Skills Improvement System-Social Skills Scub-scale | 83.95 units on a scale STANDARD_DEVIATION 9.1 | 84.85 units on a scale STANDARD_DEVIATION 11.85 | 85.79 units on a scale STANDARD_DEVIATION 13.9 |
| Test of Word Reading Efficiency (TOWRE) | 92.8 units on a scale STANDARD_DEVIATION 15.9 | 95.24 units on a scale STANDARD_DEVIATION 15.8 | 97.63 units on a scale STANDARD_DEVIATION 13.8 |
| Wechsler Abbreviated Scale of Intelligence (WASI) | 105.65 units on a scale STANDARD_DEVIATION 13 | 104.03 units on a scale STANDARD_DEVIATION 12.7 | 102.32 units on a scale STANDARD_DEVIATION 10.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 19 |
| other Total, other adverse events | 0 / 20 | 0 / 19 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 |
Outcome results
Primary
ADHD-Rating Scale (ADHD-RS) at 16 Weeks Follow-up
Attention Deficit/Hyperactivity Rating Scale for Parents is a categorical and dimensional parent and teacher ratings of symptoms of inattention, hyperactivity, and impulsivity (min: 0.00, max: 54.00; lower scores indicate less impairment).
Time frame: At 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Treatment as Usual | ADHD-Rating Scale (ADHD-RS) at 16 Weeks Follow-up | 28.29 units on a scale | Standard Deviation 12 |
| Animal Assisted Intervention | ADHD-Rating Scale (ADHD-RS) at 16 Weeks Follow-up | 24.26 units on a scale | Standard Deviation 7.93 |
Primary
ADHD-Rating Scale (ADHD-RS) at 8 Weeks
Attention Deficit/Hyperactivity Rating Scale for Parents is a categorical and dimensional parent and teacher ratings of symptoms of inattention, hyperactivity, and impulsivity (min: 0.00, max: 54.00; lower scores indicate less impairment).
Time frame: At 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Treatment as Usual | ADHD-Rating Scale (ADHD-RS) at 8 Weeks | 29.0 units on a scale | Standard Deviation 9.1 |
| Animal Assisted Intervention | ADHD-Rating Scale (ADHD-RS) at 8 Weeks | 23.9 units on a scale | Standard Deviation 8.44 |
Primary
Self-Perception Profile for Children (SPPC) at 16 Weeks
The Self-Perception Profile for Children (SPPC; Harter) uses a 4-point Likert scale, where each item is scored from 1 to 4. The SPPC measures self-perceptions across six domains: Scholastic Competence, Social Acceptance, Athletic Competence, Physical Appearance, Behavioral Conduct, and Global Self-Worth, with a total score summing and averaging 36 items with a total score of 1 being the lowest perceived competence or adequacy, and a score of 4 represents the highest level of competence or adequacy.
Time frame: At 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Treatment as Usual | Self-Perception Profile for Children (SPPC) at 16 Weeks | 2.956 units on a scale | Standard Deviation 0.673 |
| Animal Assisted Intervention | Self-Perception Profile for Children (SPPC) at 16 Weeks | 3.236 units on a scale | Standard Deviation 0.301 |
Primary
Self-Perception Profile for Children (SPPC) at 8 Weeks
The Self-Perception Profile for Children (SPPC; Harter) uses a 4-point Likert scale, where each item is scored from 1 to 4. The SPPC measures self-perceptions across six domains: Scholastic Competence, Social Acceptance, Athletic Competence, Physical Appearance, Behavioral Conduct, and Global Self-Worth, with a total score summing and averaging 36 items with a total score of 1 being the lowest perceived competence or adequacy, and a score of 4 represents the highest level of competence or adequacy.
Time frame: At 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Treatment as Usual | Self-Perception Profile for Children (SPPC) at 8 Weeks | 2.981 units on a scale | Standard Deviation 0.613 |
| Animal Assisted Intervention | Self-Perception Profile for Children (SPPC) at 8 Weeks | 3.142 units on a scale | Standard Deviation 0.463 |
Primary
Social Responsiveness Scale (SRS-2) at 16 Weeks
The Social Responsiveness Scale, second edition, (SRS-2: Constantino) measures parent ratings of symptoms of Autism Spectrum Disorder for individuals (preschool to adulthood). It is a 65-item, 4-point Likert rating scale with item scores ranging (1-4). Total scores are summed from 5 sub-scales and transformed to a Total T-score reported above. The population mean for the Total T-score value is 50 with a standard deviation of 10, with scores of 59 and below considered normal, and higher scores indicating a greater likelihood of a clinical diagnosis of ASD.
Time frame: At 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Treatment as Usual | Social Responsiveness Scale (SRS-2) at 16 Weeks | 57.16 T-score | Standard Deviation 12 |
| Animal Assisted Intervention | Social Responsiveness Scale (SRS-2) at 16 Weeks | 58.90 T-score | Standard Deviation 9.97 |
Primary
Social Responsiveness Scale (SRS-2) at 8 Weeks
The Social Responsiveness Scale, second edition, (SRS-2: Constantino) measures parent ratings of symptoms of Autism Spectrum Disorder for individuals (preschool to adulthood). It is a 65-item, 4-point Likert rating scale with item scores ranging (1-4). Total scores are summed from 5 sub-scales and transformed to a Total T-score reported above. The population mean for the Total T-score value is 50 with a standard deviation of 10, with scores of 59 and below considered normal, and higher scores indicating a greater likelihood of a clinical diagnosis of ASD.
Time frame: At 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Treatment as Usual | Social Responsiveness Scale (SRS-2) at 8 Weeks | 57.89 T-score | Standard Deviation 9.5 |
| Animal Assisted Intervention | Social Responsiveness Scale (SRS-2) at 8 Weeks | 60.80 T-score | Standard Deviation 11.31 |
Primary
Social Skills Improvement System Rating Scale (SSIS-RS) Problem Behaviors at 16 Weeks
The Social Skills Improvement System Rating Scales, parent version, problem behaviors sub-scale (SSIS-RS; Gresham) is a norm-referenced rating form used to assess problem behaviors in children and adolescents aged 3-18. The Problem Behaviors sub-scale is composed of 33-items and utilizes a 4-point Likert scale, with item scores ranging from 0-3. The total sub-scale summed score is age-adjusted and scaled scores have a mean of 100 and a standard deviation of 15, with higher scores representing more problematic behavior.
Time frame: At 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Treatment as Usual | Social Skills Improvement System Rating Scale (SSIS-RS) Problem Behaviors at 16 Weeks | 117.63 units on a scale | Standard Deviation 17.41 |
| Animal Assisted Intervention | Social Skills Improvement System Rating Scale (SSIS-RS) Problem Behaviors at 16 Weeks | 114.10 units on a scale | Standard Deviation 12.74 |
Primary
Social Skills Improvement System Rating Scale (SSIS-RS) Problem Behaviors at 8 Weeks
The Social Skills Improvement System Rating Scales, parent version, problem behaviors sub-scale (SSIS-RS; Gresham) is a norm-referenced rating form used to assess problem behaviors in children and adolescents aged 3-18. The Problem Behaviors sub-scale is composed of 33-items and utilizes a 4-point Likert scale, with item scores ranging from 0-3. The total sub-scale summed score is age-adjusted and scaled scores have a mean of 100 and a standard deviation of 15, with higher scores representing more problematic behavior.
Time frame: At 8 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Treatment as Usual | Social Skills Improvement System Rating Scale (SSIS-RS) Problem Behaviors at 8 Weeks | 119.53 units on a scale | Standard Deviation 15.85 |
| Animal Assisted Intervention | Social Skills Improvement System Rating Scale (SSIS-RS) Problem Behaviors at 8 Weeks | 117.55 units on a scale | Standard Deviation 16.72 |
Primary
Social Skills Improvement System Rating Scales (SSIS-RS) Social Skills at 16 Weeks
The Social Skills Improvement System Rating Scales, parent version, social skills sub-scale (SSIS-RS; Gresham) is a norm-referenced rating form used to assess social skills in children and adolescents aged 3-18. The Social Skills sub-scale is composed of 46-items and utilizes a 4-point Likert scale, with item scores ranging from 0-3. The total sub-scale summed score is age-adjusted and scaled scores have a mean of 100 and a standard deviation of 15, with higher scores representing better social skills.
Time frame: At 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Treatment as Usual | Social Skills Improvement System Rating Scales (SSIS-RS) Social Skills at 16 Weeks | 89.84 units on a scale | Standard Deviation 14.5 |
| Animal Assisted Intervention | Social Skills Improvement System Rating Scales (SSIS-RS) Social Skills at 16 Weeks | 90.10 units on a scale | Standard Deviation 12.64 |
Primary
Social Skills Improvement System Rating Scales (SSIS-RS) Social Skills at 8 Weeks
The Social Skills Improvement System Rating Scales, parent version, social skills sub-scale (SSIS-RS; Gresham) is a norm-referenced rating form used to assess social skills in children and adolescents aged 3-18. The Social Skills sub-scale is composed of 46-items and utilizes a 4-point Likert scale, with item scores ranging from 0-3. The total sub-scale summed score is age-adjusted and scaled scores have a mean of 100 and a standard deviation of 15, with higher scores representing better social skills.
Time frame: At 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Treatment as Usual | Social Skills Improvement System Rating Scales (SSIS-RS) Social Skills at 8 Weeks | 90.16 units on a scale | Standard Deviation 14.5 |
| Animal Assisted Intervention | Social Skills Improvement System Rating Scales (SSIS-RS) Social Skills at 8 Weeks | 87.80 units on a scale | Standard Deviation 13.51 |
Secondary
Acute Salivary Alpha-Amylase Level (In-session Week 1)
Salivary alpha-amylase (sAA) is a biomarker of the autonomic/sympathetic nervous system (ANS/SNS) which may be acutely sensitive to intervention. Secreted sAA levels were measured from saliva samples collected at three time points during intervention sessions (arrival, 20 minutes later, and 40 minutes into the session) to determine a mean sAA level for each participant and calculate acute group mean averages at week 1.
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Treatment as Usual | Acute Salivary Alpha-Amylase Level (In-session Week 1) | 88.45 u/mL | Standard Deviation 46.4 |
| Animal Assisted Intervention | Acute Salivary Alpha-Amylase Level (In-session Week 1) | 88.93 u/mL | Standard Deviation 61.2 |
Secondary
Acute Salivary Alpha-Amylase Level (In-session Week 4)
Salivary alpha-amylase (sAA) is a biomarker of the autonomic/sympathetic nervous system (ANS/SNS) which may be acutely sensitive to intervention. Secreted sAA levels were measured from saliva samples collected at three time points during intervention sessions (arrival, 20 minutes later, and 40 minutes into the session) to determine a mean sAA level for each participant and calculate acute group mean averages at week 4.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Treatment as Usual | Acute Salivary Alpha-Amylase Level (In-session Week 4) | 77.27 u/mL | Standard Deviation 51.4 |
| Animal Assisted Intervention | Acute Salivary Alpha-Amylase Level (In-session Week 4) | 84.68 u/mL | Standard Deviation 54.9 |
Secondary
Acute Salivary Alpha-Amylase Level (In-session Week 8)
Salivary alpha-amylase (sAA) is a biomarker of the autonomic/sympathetic nervous system (ANS/SNS) which may be acutely sensitive to intervention. Secreted sAA levels were measured from saliva samples collected at three time points during intervention sessions (arrival, 20 minutes later, and 40 minutes into the session) to determine a mean sAA level for each participant and calculate acute group mean averages at week 8.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Treatment as Usual | Acute Salivary Alpha-Amylase Level (In-session Week 8) | 78.23 u/mL | Standard Deviation 61.5 |
| Animal Assisted Intervention | Acute Salivary Alpha-Amylase Level (In-session Week 8) | 94.34 u/mL | Standard Deviation 65.5 |
Secondary
Acute Salivary Cortisol Level (In-session Week 1)
Cortisol is a stress-sensitive hormone which may be acutely sensitive to intervention. Secreted cortisol levels were measured from saliva samples collected at three time points during intervention sessions (arrival, 20 minutes later, and 40 minutes into the session) and to determine a mean cortisol level for each participant and calculate acute group mean averages at week 1.
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Treatment as Usual | Acute Salivary Cortisol Level (In-session Week 1) | .138 ug/mL | Standard Deviation 0.13 |
| Animal Assisted Intervention | Acute Salivary Cortisol Level (In-session Week 1) | .141 ug/mL | Standard Deviation 0.16 |
Secondary
Acute Salivary Cortisol Level (In-session Week 4)
Cortisol is a stress-sensitive hormone which may be acutely sensitive to intervention. Secreted cortisol levels were measured from saliva samples collected at three time points during intervention sessions (arrival, 20 minutes later, and 40 minutes into the session) and to determine a mean cortisol level for each participant and calculate acute group mean averages at week 4.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Treatment as Usual | Acute Salivary Cortisol Level (In-session Week 4) | .103 ug/mL | Standard Deviation 0.051 |
| Animal Assisted Intervention | Acute Salivary Cortisol Level (In-session Week 4) | .102 ug/mL | Standard Deviation 0.059 |
Secondary
Acute Salivary Cortisol Level (In-session Week 8)
Cortisol is a stress-sensitive hormone which may be acutely sensitive to intervention. Secreted cortisol levels were measured from saliva samples collected at three time points during intervention sessions (arrival, 20 minutes later, and 40 minutes into the session) and to determine a mean cortisol level for each participant and calculate acute group mean averages at week 8.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Treatment as Usual | Acute Salivary Cortisol Level (In-session Week 8) | .101 ug/mL | Standard Deviation 0.053 |
| Animal Assisted Intervention | Acute Salivary Cortisol Level (In-session Week 8) | .101 ug/mL | Standard Deviation 0.058 |
Secondary
Acute Salivary Uric Acid Level (In-session Week 1)
Salivary Uric Acid (sUA) is a biomarker that may be associated with increases in blood pressure in response to stress and self-perception of power suggesting that sUA may play an important role in self-competence and is thought to contribute to motivation and productivity. Concentration of sUA was measured from saliva collected at one time time point (arrival) prior to intervention session 1. Interpretation of values requires consideration of the context and was collected at Week 1 for exploratory comparison to other variables
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Treatment as Usual | Acute Salivary Uric Acid Level (In-session Week 1) | 2.80 mg/dL | Standard Deviation 1.16 |
| Animal Assisted Intervention | Acute Salivary Uric Acid Level (In-session Week 1) | 2.35 mg/dL | Standard Deviation 0.77 |
Secondary
Alpha-Amylase From Saliva at 16 Weeks
Salivary Alpha Amylase (sAA) is an enzyme marker of the autonomic/sympathetic nervous system (ANS/SNS) steadily rises over the day. Diurnal change is measured as a positive slope value. Steeper slope indicates faster increase in sAA levels and has been associated with poor health outcomes. Secreted sAA levels were measured from saliva collected at three time points (awakening, morning, bedtime) over two days before the follow-up session (week 16, or 8 weeks post-intervention) to calculate baseline group mean slope. Interpretation of values requires consideration of the context and was collected at 16-weeks for comparison to other variables.
Time frame: At 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Treatment as Usual | Alpha-Amylase From Saliva at 16 Weeks | 5.74 u/mL per day | Standard Error 16.7 |
| Animal Assisted Intervention | Alpha-Amylase From Saliva at 16 Weeks | 13.37 u/mL per day | Standard Error 19.86 |
Secondary
Alpha-Amylase From Saliva at 8 Weeks
Salivary Alpha Amylase (sAA) is an enzyme marker of the autonomic/sympathetic nervous system (ANS/SNS) steadily rises over the day. Diurnal change is measured as a positive slope value. Steeper slope indicates faster increase in sAA levels and has been associated with poor health outcomes. Secreted sAA levels were measured from saliva collected at three time points (awakening, morning, bedtime) over two days before the last intervention intervention session (week 8) to calculate baseline group mean slope. Interpretation of values requires consideration of the context and was collected at 8-weeks for comparison to other variables.
Time frame: At 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Treatment as Usual | Alpha-Amylase From Saliva at 8 Weeks | 11.21 u/mL per day | Standard Deviation 17.6 |
| Animal Assisted Intervention | Alpha-Amylase From Saliva at 8 Weeks | 17.21 u/mL per day | Standard Deviation 22.2 |
Secondary
Diurnal Salivary Cortisol Levels at 16 Weeks
Cortisol is a stress-sensitive hormone which follows a diurnal cycle. Diurnal change in cortisol is typically measured as a negative slope value with average scores often around -1.00, with steeper (more negative) scores associated with well-being and flatter diurnal cortisol slopes associated with chronic psychosocial stress and poor outcomes in past theory and research. Secreted cortisol levels were measured from saliva samples were collected at three time points (awakening, morning, bedtime) across two days at 8 weeks following end of the intervention (at 16 weeks from baseline) to calculate follow-up group mean slopes.
Time frame: At 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Treatment as Usual | Diurnal Salivary Cortisol Levels at 16 Weeks | -.125 ug/mL per day | Standard Deviation 0.13 |
| Animal Assisted Intervention | Diurnal Salivary Cortisol Levels at 16 Weeks | -.136 ug/mL per day | Standard Deviation 0.1 |
Secondary
Diurnal Salivary Cortisol Levels at 8 Weeks
Cortisol is a stress-sensitive hormone which follows a diurnal cycle. Diurnal change in cortisol is typically measured as a negative slope value with average scores often around -1.00, with steeper (more negative) scores associated with well-being and flatter diurnal cortisol slopes associated with chronic psychosocial stress and poor outcomes in past theory and research. Secreted cortisol levels were measured from saliva samples were collected at three time points (awakening, morning, bedtime) across two days at the end of the intervention (at 8 weeks from baseline) to calculate end of treatment group mean slopes.
Time frame: At 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Treatment as Usual | Diurnal Salivary Cortisol Levels at 8 Weeks | -.1378 ug/mL per day | Standard Deviation 0.08 |
| Animal Assisted Intervention | Diurnal Salivary Cortisol Levels at 8 Weeks | -.104 ug/mL per day | Standard Deviation 0.1 |
Secondary
Salivary Uric Acid Level (In-session Week 4)
Salivary Uric Acid (sUA) is a biomarker that may be associated with increases in blood pressure in response to stress and self-perception of power suggesting that sUA may play an important role in self-competence and is thought to contribute to motivation and productivity. Concentration of sUA was measured from saliva collected at one time time point (arrival) prior to intervention session 1. Interpretation of values requires consideration of the context and was collected at Week 4 for exploratory comparison to other variables
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Treatment as Usual | Salivary Uric Acid Level (In-session Week 4) | 2.70 mg/dL | Standard Deviation 1.18 |
| Animal Assisted Intervention | Salivary Uric Acid Level (In-session Week 4) | 2.35 mg/dL | Standard Deviation 0.821 |
Secondary
Salivary Uric Acid Level (In-session Week 8)
Salivary Uric Acid (sUA) is a biomarker that may be associated with increases in blood pressure in response to stress and self-perception of power suggesting that sUA may play an important role in self-competence and is thought to contribute to motivation and productivity. Concentration of sUA was measured from saliva collected at one time time point (arrival) prior to intervention session 1. Interpretation of values requires consideration of the context and was collected at Week 8 for exploratory comparison to other variables
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Treatment as Usual | Salivary Uric Acid Level (In-session Week 8) | 2.98 mg/dL | Standard Deviation 1.12 |
| Animal Assisted Intervention | Salivary Uric Acid Level (In-session Week 8) | 2.21 mg/dL | Standard Deviation 0.83 |