Animal Assisted Intervention With Dogs for Children With ADHD (NCT05102344) | Clinical Trial Compass
CompletedNot Applicable
Animal Assisted Intervention With Dogs for Children With ADHD
United States39 participantsStarted 2021-09-17
Plain-language summary
This pilot study aims to replicate results of a previously studied novel, non-pharmacological psychosocial intervention for children with ADHD, utilizing an Animal Assisted Intervention with therapy dogs combined with traditional social skills training (AAI) compared to psychosocial treatment as usual with social skills training alone (TAU). This study also aims to determine if candidate physiological markers of HPA axis and ANS activity differ between groups and if these markers moderate response to the interventions.
Who can participate
Age range
7 Years – 9 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Meets research criteria for a diagnosis of ADHD based on the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
* Has never taken stimulant medication or has had at least a 6 week 'wash-out' period from stimulant medicines not related to enrollment in the study.
Exclusion Criteria:
* Is currently taking stimulant medications or has taken stimulant medications within the last 6 weeks
* Allergy to dogs
* Significant fear of dogs
* Family history or history of cruelty to animals
* Meets research criteria for a diagnosis of Autism Spectrum Disorder (ASD) based on the K-SADS and Autism Specturm Rating Scale (ASRS) total raw score in the 'severe range'
* Meets research criteria for a diagnosis of Major Depressive Disorder on the K-SADS
* Meets research criteria for a diagnosis of Schizophrenia on the K-SADS
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
ADHD-Rating Scale (ADHD-RS) at 8 Weeks
Timeframe: At 8 weeks
2
ADHD-Rating Scale (ADHD-RS) at 16 Weeks Follow-up
Timeframe: At 16 weeks
3
Self-Perception Profile for Children (SPPC) at 8 Weeks
Timeframe: At 8 weeks
4
Self-Perception Profile for Children (SPPC) at 16 Weeks
Timeframe: At 16 weeks
5
Social Responsiveness Scale (SRS-2) at 8 Weeks
Timeframe: At 8 weeks
6
Social Responsiveness Scale (SRS-2) at 16 Weeks
Timeframe: At 16 weeks
7
Social Skills Improvement System Rating Scales (SSIS-RS) Social Skills at 8 Weeks