Trial Outcomes & Findings for Animal Assisted Intervention With Dogs for Children With ADHD (NCT NCT05102344)
NCT ID: NCT05102344
Last Updated: 2025-09-12
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
At 8 weeks
Results posted on
2025-09-12
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
20
|
|
Overall Study
COMPLETED
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Implementation error. Scale was not captured at two baseline visits.
Baseline characteristics by cohort
| Measure |
Psychosocial Treatment as Usual
n=19 Participants
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.
|
Animal Assisted Intervention
n=20 Participants
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
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
19 Participants
n=19 Participants
|
20 Participants
n=20 Participants
|
39 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=19 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=19 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=39 Participants
|
|
Age, Continuous
|
8.409 years
n=19 Participants
|
8.207 years
n=20 Participants
|
8.305 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=19 Participants
|
4 Participants
n=20 Participants
|
8 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=19 Participants
|
16 Participants
n=20 Participants
|
31 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=19 Participants
|
5 Participants
n=20 Participants
|
7 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=19 Participants
|
13 Participants
n=20 Participants
|
29 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=19 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=19 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=19 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=19 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=19 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=19 Participants
|
14 Participants
n=20 Participants
|
28 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=19 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=19 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=19 Participants
|
20 participants
n=20 Participants
|
39 participants
n=39 Participants
|
|
Attention Deficit Hyperactivity Disorder-Rating Scale
|
41.84 units on a scale
STANDARD_DEVIATION 8.1 • n=19 Participants • Implementation error. Scale was not captured at two baseline visits.
|
42.06 units on a scale
STANDARD_DEVIATION 7.9 • n=18 Participants • Implementation error. Scale was not captured at two baseline visits.
|
41.9 units on a scale
STANDARD_DEVIATION 8.2 • n=37 Participants • Implementation error. Scale was not captured at two baseline visits.
|
|
Autism Spectrum Rating System (ASRS)
|
57.37 units on a scale
STANDARD_DEVIATION 9.1 • n=19 Participants • Implementation error. Scale was not completed by three parents.
|
56.82 units on a scale
STANDARD_DEVIATION 9.7 • n=17 Participants • Implementation error. Scale was not completed by three parents.
|
57.11 units on a scale
STANDARD_DEVIATION 9.6 • n=36 Participants • Implementation error. Scale was not completed by three parents.
|
|
Wechsler Abbreviated Scale of Intelligence (WASI)
|
102.32 units on a scale
STANDARD_DEVIATION 10.3 • n=19 Participants
|
105.65 units on a scale
STANDARD_DEVIATION 13.0 • n=20 Participants
|
104.03 units on a scale
STANDARD_DEVIATION 12.7 • n=39 Participants
|
|
Test of Word Reading Efficiency (TOWRE)
|
97.63 units on a scale
STANDARD_DEVIATION 13.8 • n=19 Participants • One participant was unable to complete the assessment.
|
92.8 units on a scale
STANDARD_DEVIATION 15.9 • n=19 Participants • One participant was unable to complete the assessment.
|
95.24 units on a scale
STANDARD_DEVIATION 15.8 • n=38 Participants • One participant was unable to complete the assessment.
|
|
Social Responsiveness Scale (SRS-2)
|
62.06 T-Score
STANDARD_DEVIATION 10.95 • n=18 Participants • This measure was not gathered for first three participants and one additional parent refused.
|
61.53 T-Score
STANDARD_DEVIATION 10.9 • n=17 Participants • This measure was not gathered for first three participants and one additional parent refused.
|
61.8 T-Score
STANDARD_DEVIATION 10.77 • n=35 Participants • This measure was not gathered for first three participants and one additional parent refused.
|
|
National Institutes of Health Toolkit-Flanker Task
|
90.79 units on a scale
STANDARD_DEVIATION 10.7 • n=19 Participants • One participant refused to complete the assessment task.
|
88.68 units on a scale
STANDARD_DEVIATION 12.5 • n=19 Participants • One participant refused to complete the assessment task.
|
89.74 units on a scale
STANDARD_DEVIATION 11.6 • n=38 Participants • One participant refused to complete the assessment task.
|
|
NIH Toolkit List Sort Task
|
90.58 units on a scale
STANDARD_DEVIATION 16.0 • n=19 Participants • Two participants refused, were absent, or unable to complete the assessment.
|
96.89 units on a scale
STANDARD_DEVIATION 14.9 • n=18 Participants • Two participants refused, were absent, or unable to complete the assessment.
|
93.7 units on a scale
STANDARD_DEVIATION 15.2 • n=37 Participants • Two participants refused, were absent, or unable to complete the assessment.
|
|
NIH Toolkit Dimensional Change
|
91.74 units on a scale
STANDARD_DEVIATION 12.1 • n=19 Participants • One participants refused, were absent, or unable to complete the assessment.
|
92.21 units on a scale
STANDARD_DEVIATION 12.5 • n=19 Participants • One participants refused, were absent, or unable to complete the assessment.
|
91.97 units on a scale
STANDARD_DEVIATION 12.3 • n=38 Participants • One participants refused, were absent, or unable to complete the assessment.
|
|
Social Skills Improvement System-Social Skills Scub-scale
|
85.79 units on a scale
STANDARD_DEVIATION 13.9 • n=18 Participants • Parent rater neglected to complete rating scales for 4 participants
|
83.95 units on a scale
STANDARD_DEVIATION 9.1 • n=17 Participants • Parent rater neglected to complete rating scales for 4 participants
|
84.85 units on a scale
STANDARD_DEVIATION 11.85 • n=35 Participants • Parent rater neglected to complete rating scales for 4 participants
|
|
Social Skills Improvement System-Problem Behaviors
|
122.58 units on a scale
STANDARD_DEVIATION 15.56 • n=18 Participants • parent neglected to complete rating scale for 4 participants
|
122.40 units on a scale
STANDARD_DEVIATION 13.89 • n=17 Participants • parent neglected to complete rating scale for 4 participants
|
122.49 units on a scale
STANDARD_DEVIATION 14.53 • n=35 Participants • parent neglected to complete rating scale for 4 participants
|
|
Self-Perception Profile for Children (Harter)
|
3.05 units on a scale
STANDARD_DEVIATION 0.601 • n=19 Participants
|
3.08 units on a scale
STANDARD_DEVIATION 0.514 • n=20 Participants
|
3.06 units on a scale
STANDARD_DEVIATION 0.605 • n=39 Participants
|
|
Diurnal Salivary Cortisol Levels at Baseline
|
-.13959 ug/mL per day
STANDARD_DEVIATION .06 • n=18 Participants • One participant refused to provide a saliva sample at this time point.
|
-.14196 ug/mL per day
STANDARD_DEVIATION .07 • n=20 Participants • One participant refused to provide a saliva sample at this time point.
|
-.1408 ug/mL per day
STANDARD_DEVIATION .06 • n=38 Participants • One participant refused to provide a saliva sample at this time point.
|
|
Diurnal Salivary Alpha-Amylase at Baseline
|
4.90406 u/mL per day
STANDARD_DEVIATION 14.95 • n=18 Participants • One participant refused to provide a saliva sample at this collection point.
|
8.1836 u/mL per day
STANDARD_DEVIATION 14.83 • n=20 Participants • One participant refused to provide a saliva sample at this collection point.
|
6.63 u/mL per day
STANDARD_DEVIATION 14.9 • n=38 Participants • One participant refused to provide a saliva sample at this collection point.
|
|
Salivary Uric Acid at Baseline
|
3.51 mg/dL
STANDARD_DEVIATION 2.51 • n=18 Participants • One participant refused to provide a saliva sample at this collection point.
|
3.34 mg/dL
STANDARD_DEVIATION 2.29 • n=20 Participants • One participant refused to provide a saliva sample at this collection point.
|
3.44 mg/dL
STANDARD_DEVIATION 2.40 • n=38 Participants • One participant refused to provide a saliva sample at this collection point.
|
PRIMARY outcome
Timeframe: At 8 weeksAttention 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).
Outcome measures
| Measure |
Psychosocial Treatment as Usual
n=19 Participants
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.
|
Animal Assisted Intervention
n=20 Participants
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
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|---|---|---|
|
ADHD-Rating Scale (ADHD-RS) at 8 Weeks
|
29.0 units on a scale
Standard Deviation 9.1
|
23.9 units on a scale
Standard Deviation 8.44
|
PRIMARY outcome
Timeframe: At 16 weeksAttention 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).
Outcome measures
| Measure |
Psychosocial Treatment as Usual
n=17 Participants
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.
|
Animal Assisted Intervention
n=19 Participants
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
|
|---|---|---|
|
ADHD-Rating Scale (ADHD-RS) at 16 Weeks Follow-up
|
28.29 units on a scale
Standard Deviation 12.0
|
24.26 units on a scale
Standard Deviation 7.93
|
PRIMARY outcome
Timeframe: At 8 weeksThe 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.
Outcome measures
| Measure |
Psychosocial Treatment as Usual
n=18 Participants
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.
|
Animal Assisted Intervention
n=20 Participants
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
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|---|---|---|
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Self-Perception Profile for Children (SPPC) at 8 Weeks
|
2.981 units on a scale
Standard Deviation .613
|
3.142 units on a scale
Standard Deviation .463
|
PRIMARY outcome
Timeframe: At 16 weeksThe 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.
Outcome measures
| Measure |
Psychosocial Treatment as Usual
n=19 Participants
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.
|
Animal Assisted Intervention
n=19 Participants
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
|
|---|---|---|
|
Self-Perception Profile for Children (SPPC) at 16 Weeks
|
2.956 units on a scale
Standard Deviation 0.673
|
3.236 units on a scale
Standard Deviation 0.301
|
PRIMARY outcome
Timeframe: At 8 weeksThe 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.
Outcome measures
| Measure |
Psychosocial Treatment as Usual
n=18 Participants
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.
|
Animal Assisted Intervention
n=17 Participants
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
|
|---|---|---|
|
Social Responsiveness Scale (SRS-2) at 8 Weeks
|
57.89 T-score
Standard Deviation 9.5
|
60.80 T-score
Standard Deviation 11.31
|
PRIMARY outcome
Timeframe: At 16 weeksThe 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.
Outcome measures
| Measure |
Psychosocial Treatment as Usual
n=18 Participants
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.
|
Animal Assisted Intervention
n=17 Participants
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
|
|---|---|---|
|
Social Responsiveness Scale (SRS-2) at 16 Weeks
|
57.16 T-score
Standard Deviation 12.00
|
58.90 T-score
Standard Deviation 9.97
|
PRIMARY outcome
Timeframe: At 8 weeksThe 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.
Outcome measures
| Measure |
Psychosocial Treatment as Usual
n=19 Participants
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.
|
Animal Assisted Intervention
n=20 Participants
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
|
|---|---|---|
|
Social Skills Improvement System Rating Scales (SSIS-RS) Social Skills at 8 Weeks
|
90.16 units on a scale
Standard Deviation 14.50
|
87.80 units on a scale
Standard Deviation 13.51
|
PRIMARY outcome
Timeframe: At 16 weeksThe 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.
Outcome measures
| Measure |
Psychosocial Treatment as Usual
n=19 Participants
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.
|
Animal Assisted Intervention
n=20 Participants
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
|
|---|---|---|
|
Social Skills Improvement System Rating Scales (SSIS-RS) Social Skills at 16 Weeks
|
89.84 units on a scale
Standard Deviation 14.50
|
90.10 units on a scale
Standard Deviation 12.64
|
PRIMARY outcome
Timeframe: At 8 WeeksThe 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.
Outcome measures
| Measure |
Psychosocial Treatment as Usual
n=19 Participants
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.
|
Animal Assisted Intervention
n=20 Participants
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
|
|---|---|---|
|
Social Skills Improvement System Rating Scale (SSIS-RS) Problem Behaviors at 8 Weeks
|
119.53 units on a scale
Standard Deviation 15.85
|
117.55 units on a scale
Standard Deviation 16.72
|
PRIMARY outcome
Timeframe: At 16 weeksThe 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.
Outcome measures
| Measure |
Psychosocial Treatment as Usual
n=19 Participants
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.
|
Animal Assisted Intervention
n=20 Participants
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
|
|---|---|---|
|
Social Skills Improvement System Rating Scale (SSIS-RS) Problem Behaviors at 16 Weeks
|
117.63 units on a scale
Standard Deviation 17.41
|
114.10 units on a scale
Standard Deviation 12.74
|
SECONDARY outcome
Timeframe: At 8 weeksCortisol 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.
Outcome measures
| Measure |
Psychosocial Treatment as Usual
n=18 Participants
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.
|
Animal Assisted Intervention
n=20 Participants
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
|
|---|---|---|
|
Diurnal Salivary Cortisol Levels at 8 Weeks
|
-.1378 ug/mL per day
Standard Deviation 0.08
|
-.104 ug/mL per day
Standard Deviation .10
|
SECONDARY outcome
Timeframe: At 16 weeksCortisol 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.
Outcome measures
| Measure |
Psychosocial Treatment as Usual
n=18 Participants
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.
|
Animal Assisted Intervention
n=19 Participants
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
|
|---|---|---|
|
Diurnal Salivary Cortisol Levels at 16 Weeks
|
-.125 ug/mL per day
Standard Deviation .13
|
-.136 ug/mL per day
Standard Deviation .10
|
SECONDARY outcome
Timeframe: 1 weekCortisol 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.
Outcome measures
| Measure |
Psychosocial Treatment as Usual
n=19 Participants
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.
|
Animal Assisted Intervention
n=20 Participants
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
|
|---|---|---|
|
Acute Salivary Cortisol Level (In-session Week 1)
|
.138 ug/mL
Standard Deviation .13
|
.141 ug/mL
Standard Deviation .16
|
SECONDARY outcome
Timeframe: 4 weeksCortisol 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.
Outcome measures
| Measure |
Psychosocial Treatment as Usual
n=19 Participants
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.
|
Animal Assisted Intervention
n=20 Participants
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
|
|---|---|---|
|
Acute Salivary Cortisol Level (In-session Week 4)
|
.103 ug/mL
Standard Deviation .051
|
.102 ug/mL
Standard Deviation .059
|
SECONDARY outcome
Timeframe: 8 weeksCortisol 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.
Outcome measures
| Measure |
Psychosocial Treatment as Usual
n=18 Participants
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.
|
Animal Assisted Intervention
n=18 Participants
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
|
|---|---|---|
|
Acute Salivary Cortisol Level (In-session Week 8)
|
.101 ug/mL
Standard Deviation .053
|
.101 ug/mL
Standard Deviation .058
|
SECONDARY outcome
Timeframe: At 8 weeksSalivary 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.
Outcome measures
| Measure |
Psychosocial Treatment as Usual
n=18 Participants
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.
|
Animal Assisted Intervention
n=20 Participants
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
|
|---|---|---|
|
Alpha-Amylase From Saliva at 8 Weeks
|
11.21 u/mL per day
Standard Deviation 17.6
|
17.21 u/mL per day
Standard Deviation 22.2
|
SECONDARY outcome
Timeframe: At 16 weeksSalivary 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.
Outcome measures
| Measure |
Psychosocial Treatment as Usual
n=18 Participants
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.
|
Animal Assisted Intervention
n=19 Participants
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
|
|---|---|---|
|
Alpha-Amylase From Saliva at 16 Weeks
|
5.74 u/mL per day
Standard Error 16.7
|
13.37 u/mL per day
Standard Error 19.86
|
SECONDARY outcome
Timeframe: 1 weekSalivary 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.
Outcome measures
| Measure |
Psychosocial Treatment as Usual
n=19 Participants
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.
|
Animal Assisted Intervention
n=20 Participants
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
|
|---|---|---|
|
Acute Salivary Alpha-Amylase Level (In-session Week 1)
|
88.45 u/mL
Standard Deviation 46.4
|
88.93 u/mL
Standard Deviation 61.2
|
SECONDARY outcome
Timeframe: 4 weeksSalivary 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.
Outcome measures
| Measure |
Psychosocial Treatment as Usual
n=19 Participants
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.
|
Animal Assisted Intervention
n=20 Participants
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
|
|---|---|---|
|
Acute Salivary Alpha-Amylase Level (In-session Week 4)
|
77.27 u/mL
Standard Deviation 51.4
|
84.68 u/mL
Standard Deviation 54.9
|
SECONDARY outcome
Timeframe: 8 weeksSalivary 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.
Outcome measures
| Measure |
Psychosocial Treatment as Usual
n=18 Participants
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.
|
Animal Assisted Intervention
n=18 Participants
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
|
|---|---|---|
|
Acute Salivary Alpha-Amylase Level (In-session Week 8)
|
78.23 u/mL
Standard Deviation 61.5
|
94.34 u/mL
Standard Deviation 65.5
|
SECONDARY outcome
Timeframe: 1 weekSalivary 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
Outcome measures
| Measure |
Psychosocial Treatment as Usual
n=19 Participants
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.
|
Animal Assisted Intervention
n=20 Participants
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
|
|---|---|---|
|
Acute Salivary Uric Acid Level (In-session Week 1)
|
2.80 mg/dL
Standard Deviation 1.16
|
2.35 mg/dL
Standard Deviation .77
|
SECONDARY outcome
Timeframe: 4 weeksSalivary 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
Outcome measures
| Measure |
Psychosocial Treatment as Usual
n=19 Participants
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.
|
Animal Assisted Intervention
n=20 Participants
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
|
|---|---|---|
|
Salivary Uric Acid Level (In-session Week 4)
|
2.70 mg/dL
Standard Deviation 1.18
|
2.35 mg/dL
Standard Deviation .821
|
SECONDARY outcome
Timeframe: 8 weeksSalivary 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
Outcome measures
| Measure |
Psychosocial Treatment as Usual
n=18 Participants
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.
|
Animal Assisted Intervention
n=18 Participants
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
|
|---|---|---|
|
Salivary Uric Acid Level (In-session Week 8)
|
2.98 mg/dL
Standard Deviation 1.12
|
2.21 mg/dL
Standard Deviation .83
|
Adverse Events
Animal Assisted Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Psychosocial Treatment as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sabrina E.B. Schuck, Ph.D.
University of California, Irvine
Phone: 9495335465
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place