Animal Assisted Intervention With Dogs for Children With ADHD

NCT05102344 | Completed Results DMC

• 2 other identifiers: 20206069R21HD103422
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study aims to replicate results of a previously studied novel, non-pharmacological psychosocial intervention for children with ADHD, utilizing an Animal Assisted Intervention with therapy dogs combined with traditional social skills training (AAI) compared to psychosocial treatment as usual with social skills training alone (TAU). This study also aims to determine if candidate physiological markers of HPA axis and ANS activity differ between groups and if these markers moderate response to the interventions.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Animal Assisted Intervention; Social Skills Training

Outcome Measures

Primary Outcomes (10)

• ADHD-Rating Scale (ADHD-RS) at 8 Weeks

  Attention Deficit/Hyperactivity Rating Scale for Parents is a categorical and dimensional parent and teacher ratings of symptoms of inattention, hyperactivity, and impulsivity (min: 0.00, max: 54.00; lower scores indicate less impairment).

  At 8 weeks

• ADHD-Rating Scale (ADHD-RS) at 16 Weeks Follow-up

  Attention Deficit/Hyperactivity Rating Scale for Parents is a categorical and dimensional parent and teacher ratings of symptoms of inattention, hyperactivity, and impulsivity (min: 0.00, max: 54.00; lower scores indicate less impairment).

  At 16 weeks

• Self-Perception Profile for Children (SPPC) at 8 Weeks

  The Self-Perception Profile for Children (SPPC; Harter) uses a 4-point Likert scale, where each item is scored from 1 to 4. The SPPC measures self-perceptions across six domains: Scholastic Competence, Social Acceptance, Athletic Competence, Physical Appearance, Behavioral Conduct, and Global Self-Worth, with a total score summing and averaging 36 items with a total score of 1 being the lowest perceived competence or adequacy, and a score of 4 represents the highest level of competence or adequacy.

  At 8 weeks

• Self-Perception Profile for Children (SPPC) at 16 Weeks

  The Self-Perception Profile for Children (SPPC; Harter) uses a 4-point Likert scale, where each item is scored from 1 to 4. The SPPC measures self-perceptions across six domains: Scholastic Competence, Social Acceptance, Athletic Competence, Physical Appearance, Behavioral Conduct, and Global Self-Worth, with a total score summing and averaging 36 items with a total score of 1 being the lowest perceived competence or adequacy, and a score of 4 represents the highest level of competence or adequacy.

  At 16 weeks

• Social Responsiveness Scale (SRS-2) at 8 Weeks

  The Social Responsiveness Scale, second edition, (SRS-2: Constantino) measures parent ratings of symptoms of Autism Spectrum Disorder for individuals (preschool to adulthood). It is a 65-item, 4-point Likert rating scale with item scores ranging (1-4). Total scores are summed from 5 sub-scales and transformed to a Total T-score reported above. The population mean for the Total T-score value is 50 with a standard deviation of 10, with scores of 59 and below considered normal, and higher scores indicating a greater likelihood of a clinical diagnosis of ASD.

  At 8 weeks

• Social Responsiveness Scale (SRS-2) at 16 Weeks

  The Social Responsiveness Scale, second edition, (SRS-2: Constantino) measures parent ratings of symptoms of Autism Spectrum Disorder for individuals (preschool to adulthood). It is a 65-item, 4-point Likert rating scale with item scores ranging (1-4). Total scores are summed from 5 sub-scales and transformed to a Total T-score reported above. The population mean for the Total T-score value is 50 with a standard deviation of 10, with scores of 59 and below considered normal, and higher scores indicating a greater likelihood of a clinical diagnosis of ASD.

  At 16 weeks

• Social Skills Improvement System Rating Scales (SSIS-RS) Social Skills at 8 Weeks

  The Social Skills Improvement System Rating Scales, parent version, social skills sub-scale (SSIS-RS; Gresham) is a norm-referenced rating form used to assess social skills in children and adolescents aged 3-18. The Social Skills sub-scale is composed of 46-items and utilizes a 4-point Likert scale, with item scores ranging from 0-3. The total sub-scale summed score is age-adjusted and scaled scores have a mean of 100 and a standard deviation of 15, with higher scores representing better social skills.

  At 8 weeks

• Social Skills Improvement System Rating Scales (SSIS-RS) Social Skills at 16 Weeks

  The Social Skills Improvement System Rating Scales, parent version, social skills sub-scale (SSIS-RS; Gresham) is a norm-referenced rating form used to assess social skills in children and adolescents aged 3-18. The Social Skills sub-scale is composed of 46-items and utilizes a 4-point Likert scale, with item scores ranging from 0-3. The total sub-scale summed score is age-adjusted and scaled scores have a mean of 100 and a standard deviation of 15, with higher scores representing better social skills.

  At 16 weeks

• Social Skills Improvement System Rating Scale (SSIS-RS) Problem Behaviors at 8 Weeks

  The Social Skills Improvement System Rating Scales, parent version, problem behaviors sub-scale (SSIS-RS; Gresham) is a norm-referenced rating form used to assess problem behaviors in children and adolescents aged 3-18. The Problem Behaviors sub-scale is composed of 33-items and utilizes a 4-point Likert scale, with item scores ranging from 0-3. The total sub-scale summed score is age-adjusted and scaled scores have a mean of 100 and a standard deviation of 15, with higher scores representing more problematic behavior.

  At 8 Weeks

• Social Skills Improvement System Rating Scale (SSIS-RS) Problem Behaviors at 16 Weeks

  The Social Skills Improvement System Rating Scales, parent version, problem behaviors sub-scale (SSIS-RS; Gresham) is a norm-referenced rating form used to assess problem behaviors in children and adolescents aged 3-18. The Problem Behaviors sub-scale is composed of 33-items and utilizes a 4-point Likert scale, with item scores ranging from 0-3. The total sub-scale summed score is age-adjusted and scaled scores have a mean of 100 and a standard deviation of 15, with higher scores representing more problematic behavior.

  At 16 weeks

Secondary Outcomes (13)

• Diurnal Salivary Cortisol Levels at 8 Weeks

  At 8 weeks

• Diurnal Salivary Cortisol Levels at 16 Weeks

  At 16 weeks

• Acute Salivary Cortisol Level (In-session Week 1)

  1 week

• Acute Salivary Cortisol Level (In-session Week 4)

  4 weeks

• Acute Salivary Cortisol Level (In-session Week 8)

  8 weeks

Study Arms (2)

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

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

Behavioral: Animal Assisted Intervention

Interventions

Behavioral Social Skills Training BEHAVIORAL

Behavioral Social Skills Training treatment as usual will include small group semi-structured play, didactic instruction and role-play of basic social skills, including assertion, ignoring provocation, accepting consequences, problem solving, following directions, and self-regulation.

Psychosocial Treatment as Usual

Animal Assisted Intervention BEHAVIORAL

Behavioral Social Skills Training treatment as usual will include small group semi-structured play, didactic instruction and role-play of basic social skills, including assertion, ignoring provocation, accepting consequences, problem solving, following directions, and self-regulation accompanied by trained therapy dogs

Animal Assisted Intervention

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of California, Irvine

Irvine, California, 92697, United States

Location

Related Publications (1)

• 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.

  PMID: 39512897 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Sabrina E.B. Schuck, Ph.D.
• Organization: University of California, Irvine

sabrina@uci.edu

9495335465

Study Officials

• Sabrina EB Schuck, Ph.D.

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Lab assistants responsible for processing biological samples of interest and the principal statistician are blind to identifying participant information and group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Residence

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: November 1, 2021
• Study Start: September 17, 2021
• Primary Completion: August 30, 2023
• Study Completion: August 31, 2023
• Last Updated: September 12, 2025
• Results First Posted: September 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)