Attention Deficit Hyperactivity DisorderPACK-PMNCT05102344
Animal Assisted Intervention With Dogs for Children With ADHD
A study testing Behavioral Social Skills Training and Animal Assisted Intervention in people with Attention Deficit Hyperactivity Disorder, run by University of California, Irvine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Behavioral Social Skills Training and Animal Assisted Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2021to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine
Irvine, California, 92697
About this study
Official title: Animal Assisted Intervention With Dogs for Children With Attention Deficit/Hyperactivity Disorder; Exploring Candidate Physiological Markers of Response to AAI
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.
Read the 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Behavioral Social Skills Training, Animal Assisted Intervention
- Keywords
- Animal Assisted Intervention, Social Skills Training
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Social Skills TrainingBehavioural
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.
Animal Assisted InterventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Behavioral Social Skills Training |
| 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 Receives: Behavioral: Animal Assisted Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: At 16 weeks
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 16 weeks
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start17 Sep 2021
- Primary completion30 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Sabrina E. Brierley Schuck, Ph.D., University of California, Irvine
- Investigators
- Sabrina EB Schuck, Ph.D., Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102344
- Sponsor's protocol ID
- 20206069
- Other IDs
- R21HD103422
- Acronym
- PACK-PM
- Status last verified
- Aug 2025
- First submitted
- 8 Oct 2021
- Last updated
- 12 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39512897
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Animal Assisted Intervention With Dogs for Children With Attention Deficit/Hyperactivity Disorder; Exploring Candidate Physiological Markers of Response to AAI
- ClinicalTrials.gov ID
- NCT05102344
- Acronym / sponsor ID
- PACK-PM / 20206069
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Animal Assisted Intervention, Social Skills Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 1 Nov 2021 (actual)
- Results
- Posted 12 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychosocial Treatment as Usual | Active comparator | Behavioral: Behavioral Social Skills TrainingParticipants 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 | Behavioral: Animal Assisted InterventionParticipants 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 |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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'
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Social Skills TrainingBehavioral 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. | Behavioural | Psychosocial Treatment as Usual |
| Animal Assisted InterventionBehavioral 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 | Behavioural | Animal Assisted Intervention |
Primary outcome
ADHD-Rating Scale (ADHD-RS) at 8 Weeks
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
13 secondary outcomes
Diurnal Salivary Cortisol Levels at 8 Weeks
Time frame: At 8 weeks
Diurnal Salivary Cortisol Levels at 16 Weeks
Time frame: At 16 weeks
Acute Salivary Cortisol Level (In-session Week 1)
Time frame: 1 week
Acute Salivary Cortisol Level (In-session Week 4)
Time frame: 4 weeks
Acute Salivary Cortisol Level (In-session Week 8)
Time frame: 8 weeks
Alpha-Amylase From Saliva at 8 Weeks
Time frame: At 8 weeks
Alpha-Amylase From Saliva at 16 Weeks
Time frame: At 16 weeks
Acute Salivary Alpha-Amylase Level (In-session Week 1)
Time frame: 1 week
Acute Salivary Alpha-Amylase Level (In-session Week 4)
Time frame: 4 weeks
Acute Salivary Alpha-Amylase Level (In-session Week 8)
Time frame: 8 weeks
Acute Salivary Uric Acid Level (In-session Week 1)
Time frame: 1 week
Salivary Uric Acid Level (In-session Week 4)
Time frame: 4 weeks
Salivary Uric Acid Level (In-session Week 8)
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39512897Schuck 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.
- Individual participant dataSharing planned: No
Related trials for Attention Deficit Hyperactivity Disorder
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabrina EB Schuck, Ph.D. principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Social Skills Training and Animal Assisted Intervention in people with Attention Deficit Hyperactivity Disorder, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD-Rating Scale (ADHD-RS) at 8 Weeks (time frame: At 8 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05102344, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.