Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R21HD103422 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychosocial Treatment as Usual | Active Comparator | 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 |
|
| Animal Assisted Intervention | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Social Skills Training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At 8 weeks |
| 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). | At 16 weeks |
| 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. | At 8 weeks |
| 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. | At 16 weeks |
| Social Responsiveness Scale (SRS-2) at 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sabrina EB Schuck, Ph.D. | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine | Irvine | California | 92697 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39512897 | Derived | Schuck SEB, Zeiler CN, Stehli A, Steinhoff LA, Stokes RY, Jeffrey SE, Granger DA. Acute salivary cortisol response in children with ADHD during psychosocial intervention with and without therapy dogs. Front Psychiatry. 2024 Oct 24;15:1476522. doi: 10.3389/fpsyt.2024.1476522. eCollection 2024. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | units on a scale | At 8 weeks |
|
Participants were monitored for adverse events over the course of their participation in the study (8 weeks of intervention and 8 weeks of follow up).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sabrina E.B. Schuck, Ph.D. | University of California, Irvine | 9495335465 | sabrina@uci.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 19, 2022 | Feb 7, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 27, 2021 | Oct 8, 2021 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Lab assistants responsible for processing biological samples of interest and the principal statistician are blind to identifying participant information and group assignment.
|
| Animal Assisted Intervention | Behavioral | 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 |
|
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.
| At 8 weeks |
| 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. | At 16 weeks |
| 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. | At 8 weeks |
| 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. | At 16 weeks |
| 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. | At 8 Weeks |
| 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. | At 16 weeks |
| At 8 weeks |
| 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. | At 16 weeks |
| 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. | 1 week |
| 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. | 4 weeks |
| 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. | 8 weeks |
| 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. | At 8 weeks |
| 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. | At 16 weeks |
| 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. | 1 week |
| 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. | 4 weeks |
| 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. | 8 weeks |
| 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 | 1 week |
| 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 | 4 weeks |
| 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 | 8 weeks |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Attention Deficit Hyperactivity Disorder-Rating Scale | The Attention Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS-5; DuPaul) measures parent ratings of severity of ADHD symptoms using a 4-point Likert Scale, rating 18 items with ratings from 0-3. The total score reported represents the total for the 18 itmes, with a range of 0 to 54, with higher scores indicating greater impairment from symptoms. | Implementation error. Scale was not captured at two baseline visits. | Mean | Standard Deviation | units on a scale |
|
| Autism Spectrum Rating System (ASRS) | The Autism Spectrum Rating System, Short Form, Adapted 6-18 years (ASRS; Goldstein) is rating scale completed by parents utilizing a 5-point Likert scale (0-4) for 15 items measuring Autism symptom severity. Total values are converted to T-scores ranging from 28 to 85, with higher scores indicating greater symptoms severity, | Implementation error. Scale was not completed by three parents. | Mean | Standard Deviation | units on a scale |
|
| Wechsler Abbreviated Scale of Intelligence (WASI) | The Wechsler Abbreviated Scale of Intelligence, second edition (WASI-2;Wechsler) is a brief measure of general intelligence, or IQ test designed to assess specific and overall cognitive capabilities and is individually administered to children, adolescents and adults (ages 6-89), composed of 4 sub-scales with scores combined and transformed to an age standardized The test is based on a mean score of 100 and a standard deviation of 15, with scores typically ranging from 40 to 160, with greater scores representing higher or more proficient cognitive capabilities. | Mean | Standard Deviation | units on a scale |
|
| Test of Word Reading Efficiency (TOWRE) | The Test of Word Reading Efficiency, second edition (TOWRE-2;Torgesen, Wagner and Rashotte) is measure of reading skills for children ages 6-24, composed of 167 questions across two scales. Sub-scale scores are combined for a total score and transformed to age-based standardized scores. The test is based on a mean score of 100 and a standard deviation of 15, with total scores of less than 70 considered to be 'very poor' and scores and scores over 130 as 'very superior' with average scores falling between 90-110. | One participant was unable to complete the assessment. | Mean | Standard Deviation | units on a scale |
|
| Social Responsiveness Scale (SRS-2) | 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. | This measure was not gathered for first three participants and one additional parent refused. | Mean | Standard Deviation | T-Score |
|
| National Institutes of Health Toolkit-Flanker Task | The National Institutes of Health Toolkit, Flanker Inhibitory Control and Attention Test measures inhibitory control and attention. Scores are based on both accuracy and reaction time, and the final score is determined by an algorithm that considers both. If accuracy is less than or equal to 80%, the score is based on accuracy alone. For those with accuracy greater than 80%, the score combines accuracy and reaction time. The age-adjusted scale scores have a mean of 100 and a standard deviation of 15, with higher scores representing more inhibitory control and better attention. | One participant refused to complete the assessment task. | Mean | Standard Deviation | units on a scale |
|
| NIH Toolkit List Sort Task | The National Institutes of Health Toolkit, List Sorting Working Memory Test measures working memory skills or ability to hold and manipulate information. The age-adjusted scale scores have a mean of 100 and a standard deviation of 15, with higher scores representing better working memory performance. | Two participants refused, were absent, or unable to complete the assessment. | Mean | Standard Deviation | units on a scale |
|
| NIH Toolkit Dimensional Change | The National Institutes of Health Toolkit, Dimensional Change Card Sort test measures cognitive flexibility and attention. The age-adjusted scale scores have a mean of 100 and a standard deviation of 15, with higher scores representing better cognitive flexibility. | One participants refused, were absent, or unable to complete the assessment. | Mean | Standard Deviation | units on a scale |
|
| Social Skills Improvement System-Social Skills Scub-scale | 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. | Parent rater neglected to complete rating scales for 4 participants | Mean | Standard Deviation | units on a scale |
|
| Social Skills Improvement System-Problem Behaviors | 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. | parent neglected to complete rating scale for 4 participants | Mean | Standard Deviation | units on a scale |
|
| Self-Perception Profile for Children (Harter) | 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. | Mean | Standard Deviation | units on a scale |
|
| Diurnal Salivary Cortisol Levels at Baseline | 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 before intervention to calculate baseline group mean slope. | One participant refused to provide a saliva sample at this time point. | Mean | Standard Deviation | ug/mL per day |
|
| Diurnal Salivary Alpha-Amylase at Baseline | 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 intervention to calculate baseline group mean slope. Interpretation of values requires consideration of the context and was collected at baseline for comparison to other variables. | One participant refused to provide a saliva sample at this collection point. | Mean | Standard Deviation | u/mL per day |
|
| Salivary Uric Acid at Baseline | 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. Baseline concentration of sUA was measured from saliva collected at one time time point prior to intervention. Interpretation of values requires consideration of the context and was collected at baseline for comparison to other variables. | One participant refused to provide a saliva sample at this collection point. | Mean | Standard Deviation | mg/dL |
|
| OG001 | 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 |
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | At 16 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | At 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | At 16 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | T-score | At 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | T-score | At 16 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | At 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | At 16 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | At 8 Weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | At 16 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | ug/mL per day | At 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | ug/mL per day | At 16 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | ug/mL | 1 week |
|
|
|
| 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. | Posted | Mean | Standard Deviation | ug/mL | 4 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | ug/mL | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | u/mL per day | At 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Error | u/mL per day | At 16 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | u/mL | 1 week |
|
|
|
| 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. | Posted | Mean | Standard Deviation | u/mL | 4 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | u/mL | 8 weeks |
|
|
|
| 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 | Posted | Mean | Standard Deviation | mg/dL | 1 week |
|
|
|
| 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 | Posted | Mean | Standard Deviation | mg/dL | 4 weeks |
|
|
|
| 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 | Posted | Mean | Standard Deviation | mg/dL | 8 weeks |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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. | 0 | 19 | 0 | 19 | 0 | 19 |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|