Therapy Dogs + Behavioral Treatment for Autism

Overseen By Carrie Fassler

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Canine phobia/allergy, Animal aggression, Recent child aggression, Major neuropsychiatric illness, Major sensory impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 15

Duration: 10 weeks

240 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if having a dog in therapy sessions can help children with autism manage their emotions better. It targets kids aged 8 to 15 who struggle with emotional control. The idea is that dogs can make therapy more enjoyable and less stressful, aiding in emotional learning. Using dogs in therapy is a growing practice in autism therapy, often involving dogs to help improve emotional and behavioral outcomes.

Will I have to stop taking my current medications?

The trial requires that you keep your current medications stable throughout the study, so you won't need to stop taking them.

What data supports the effectiveness of the treatment Regulating Together-Canine for autism?

Research suggests that therapy dogs can help improve social communication skills and reduce behavioral problems in children with autism. Additionally, assistance dogs in the home have been shown to increase social participation and quality of life for individuals with autism. ^{1 2 3 4 5}

Is therapy involving dogs safe for children with autism?

Research suggests that therapy dogs can increase safety for children with autism and their families, as well as reduce stress and isolation. However, there is limited specific safety data, and more studies are needed to fully understand the long-term safety and impact of therapy dogs in these interventions. ^{1 4 6 7 8}

How does the Regulating Together-Canine treatment for autism differ from other treatments?

The Regulating Together-Canine treatment is unique because it incorporates therapy dogs to help improve social communication skills and reduce behavioral problems in children with autism. This approach is different from standard treatments as it uses the presence and interaction with dogs to enhance engagement and therapy outcomes. ^{1 4 5 6 9}

Research Team

Rebecca Shaffer, Psy.D.

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Eligibility Criteria

This trial is for children with autism spectrum disorder (ASD) who have issues with emotion regulation, confirmed by specific tests and assessments. They must be on stable medication, have an IQ score of 65 or higher, and speak English as their primary language. Children allergic to dogs, with a fear of canines, history of aggression towards animals or other children causing injury recently are excluded.

Inclusion Criteria

I have been diagnosed with autism spectrum disorder.

A Full Scale Intelligence Quotient score of 65 or greater on the Weschler Abbreviated Scale Intelligence (WASI-II)

Concern of emotion dysregulation (ED) as measured by a score of 6 or greater on the Emotion Dysregulation Inventory-Reactivity (EDI-R)

Exclusion Criteria

Presence of comorbid major neuropsychiatric illness warranting other treatment approaches as determined by the study clinician(s) including substance use disorders, psychotic disorders/schizophrenia, and bipolar disorder, among others

Participant has a phobia toward or is allergic to canines

I do not have major sensory impairments like blindness or severe hearing loss.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

All outcome measures are completed at Baseline

1 week

1 visit (in-person)

Treatment

Participants receive either Regulating Together-Canine or Regulating Together-Standard intervention over 10 group sessions

10 weeks

10 visits (in-person)

Post-treatment

Outcome measures completed 1-2 weeks following treatment completion

1-2 weeks

1 visit (in-person)

Follow-up

10 week post treatment completion follow up

10 weeks

1 visit (in-person)

Long-term Follow-up

6 month post treatment completion follow up

6 months

1 visit (in-person)

Treatment Details

Interventions

• Regulating Together-Canine
• Regulating Together-Standard

Trial Overview The study is testing if adding therapy dogs to a behavior treatment program called Regulating Together helps kids with ASD manage their emotions better than the standard program without dogs. It also looks at whether this makes kids more engaged and improves learning.

Participant Groups

Group I: Regulating Together-Canine (RT-Canine) Experimental Treatment 1 Intervention

Participants in this Arm will receive the Regulating Together-Canine intervention.

Group II: Regulating Together-Standard (RT-Standard) Active Control 1 Intervention

Participants in this Arm will receive the Regulating Together-Standard intervention.

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Findings from Research

Canine-assisted occupational therapy can enhance emotional safety and rapport between children on the autism spectrum and their therapists, as reported by parents in a study involving 10 participants.

However, the presence of a therapy dog alone is not enough to ensure engagement; the therapist's skills and the structure of goal-directed therapy are crucial for effective outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Canine-assisted occupational therapy for children on the autism spectrum: Parents' perspectives. Hill, JR., Ziviani, J., Driscoll, C.[2021]

Assistance dogs may enhance social behaviors and decrease the severity of Autism Spectrum Disorder (ASD) symptoms, as suggested by trends observed in a study comparing six families with assistance dogs to twelve families on a waiting list.

While no significant differences were found between the two groups, families with longer partnerships with assistance dogs reported better overall wellbeing, indicating potential benefits that warrant further investigation with a larger sample size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of assistance dog placement in the home for individuals with autism spectrum disorder and their families: A pilot study. Leung, JY., Mackenzie, L., Dickson, C.[2022]

Robot-assisted therapy (RAT) was implemented for the first time in a Chilean public health center, involving 4 children with Autism Spectrum Disorder (ASD) aged 9 to 13, and resulted in high patient adherence and satisfaction during 10 therapy sessions.

The therapy led to significant improvements in socialization behaviors and social interaction, as evidenced by video coding and the Vineland scale, indicating that RAT can effectively address core symptoms of ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapeutic use of robotics in children with Autism Spectrum Disorder]. Yáñez, C., Madariaga, L., López, C., et al.[2022]

In a study involving 10 children, dog-assisted therapy (DAT) showed a significant increase in synchrony between children and their therapy dogs over the course of the program, suggesting a potential mechanism for the therapy's effectiveness.

Children with autism spectrum disorder (ASD) demonstrated greater synchrony with their therapy dogs compared to children with Down syndrome (DS), indicating that DAT may have different impacts based on the child's condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in behavioural synchrony during dog-assisted therapy for children with autism spectrum disorder and children with Down syndrome. Griffioen, RE., van der Steen, S., Verheggen, T., et al.[2020]

A study involving 73 children with autism spectrum disorder showed that a dog training intervention significantly improved social communication skills when implemented early in the school year, with benefits lasting beyond the intervention period.

The intervention, conducted twice weekly for 4 months, was found to be an effective adjunct treatment in special education settings, suggesting that therapy dogs can enhance social interaction skills in young children with autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dog training intervention improves adaptive social communication skills in young children with autism spectrum disorder: A controlled crossover study. Ben-Itzchak, E., Zachor, DA.[2021]

Families with autism assistance dogs (AADs) reported increased safety and mobility, allowing them to visit more places and travel further from home, with a median increase of 8.5 locations and 20.5 km after a year of having the dog.

The presence of AADs not only reduced familial isolation but also provided a sense of freedom for families, highlighting a paradox of 'freedom through restraint' that warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Australian parents' experiences of owning an autism assistance dog. Appleby, R., Wright, S., Williams, L., et al.[2023]

In a study assessing the effectiveness of therapy dogs for children with autism spectrum disorder (ASD), one third of participants showed high preference for the dog, while another third showed low preference, indicating varied responses to therapy animals.

The study found that preference for the therapy dog was a good predictor of its effectiveness as a reinforcer in interventions, suggesting that systematic assessments should be conducted to optimize the use of therapy animals in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancing Methods in Animal-Assisted Intervention: Demonstration of Starting Points in Clinical Practice for Children with Autism Spectrum Disorder. Clay, CJ., Schmitz, BA., Hogg, AD., et al.[2023]

This pilot study developed the Lincoln Autism Pet Dog Impact Scale (LAPDIS), a 28-item scale that measures the perceived impact of pet dogs on children with autism spectrum disorder (ASD) across three factors: Adaptability, Social Skills, and Conflict Management.

Individual differences in children, such as age, disability level, and language abilities, significantly influenced how families perceived the impact of pet dogs, while family and dog characteristics were less important, highlighting the need for personalized approaches in assessing the benefits of pet dog ownership for children with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Factors Are Associated with Positive Effects of Dog Ownership in Families with Children with Autism Spectrum Disorder? The Development of the Lincoln Autism Pet Dog Impact Scale. Hall, SS., Wright, HF., Mills, DS.[2023]

A pilot study involving 22 autistic children aged 4 to 6 years explored the effects of canine-assisted occupational therapy compared to standard occupational therapy.

While there was a positive trend in on-task behaviors and goal attainment in the treatment group, the results were not statistically significant, indicating the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Canine Assisted Occupational Therapy for Children on the Autism Spectrum: A Pilot Randomised Control Trial. Hill, J., Ziviani, J., Driscoll, C., et al.[2020]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Canine-assisted occupational therapy for children on the autism spectrum: Parents' perspectives. [2021]

2. Australia pubmed.ncbi.nlm.nih.gov

Outcomes of assistance dog placement in the home for individuals with autism spectrum disorder and their families: A pilot study. [2022]

3. Chile pubmed.ncbi.nlm.nih.gov

[Therapeutic use of robotics in children with Autism Spectrum Disorder]. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Changes in behavioural synchrony during dog-assisted therapy for children with autism spectrum disorder and children with Down syndrome. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Dog training intervention improves adaptive social communication skills in young children with autism spectrum disorder: A controlled crossover study. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Australian parents' experiences of owning an autism assistance dog. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Advancing Methods in Animal-Assisted Intervention: Demonstration of Starting Points in Clinical Practice for Children with Autism Spectrum Disorder. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

What Factors Are Associated with Positive Effects of Dog Ownership in Families with Children with Autism Spectrum Disorder? The Development of the Lincoln Autism Pet Dog Impact Scale. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Canine Assisted Occupational Therapy for Children on the Autism Spectrum: A Pilot Randomised Control Trial. [2020]