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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether therapy dogs can enhance the effectiveness of a behavioral treatment called Regulating Together-Canine, which helps children with autism better manage their emotions. By comparing a group receiving therapy with dogs to one without, researchers aim to determine if the dogs lead to faster and greater improvements in emotional control and engagement. The trial seeks children diagnosed with autism who struggle with emotional regulation and whose families can maintain stable medication during the study. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to important findings.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that therapy with animals, such as the Regulating Together-Canine (RT-Canine) program, is generally safe for children with autism. In studies involving therapy dogs, children have experienced positive interactions with the dogs. No reports of serious side effects or problems caused by the therapy dogs have emerged in these settings.

This trial is in Phase 2, so researchers are still closely monitoring the treatment's safety. However, earlier studies have not identified major safety issues. Additionally, therapy dogs are already used in many therapy settings, which increases confidence in their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they combine behavioral therapy with the calming influence of therapy dogs, a novel approach for autism. Unlike standard treatments that focus solely on behavioral interventions or medications, the Regulating Together-Canine (RT-Canine) arm integrates trained therapy dogs to help participants manage emotions and social interactions. This unique combination could offer a more engaging and supportive environment for individuals with autism, potentially enhancing the effectiveness of traditional behavioral treatments. Additionally, the Regulating Together-Standard (RT-Standard) arm serves as an active comparator, helping to evaluate the added benefits of incorporating therapy dogs into autism treatment.

What evidence suggests that this trial's treatments could be effective for emotion dysregulation in children with autism?

Research shows that therapy dogs can help children with autism manage their emotions better. In this trial, participants in the Regulating Together-Canine (RT-Canine) arm will receive therapy sessions with dogs. One study found that children who had therapy sessions with dogs improved more in understanding and controlling their emotions than those who did not have dogs. Therapy with animals also links to better social behavior, meaning therapy dogs can help children interact and handle their feelings more positively. This method aims to help children participate more effectively and learn better during autism treatments. Participants in the Regulating Together-Standard (RT-Standard) arm will receive the intervention without the canine component. ^{2 4 5 6 7}

Who Is on the Research Team?

Rebecca Shaffer, Psy.D.

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

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

Diagnosis confirmed by an experienced ASD clinician and further supported by scoring in the range for ASD on the Autism Diagnostic Observation Schedule (ADOS-2)

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

A legal guardian is not available to provide informed consent

Participant has a phobia toward or is allergic to canines

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/542696

Evaluating Additive Effects of Including Canines in ... Aim 1: Evaluate whether Regulating Together-Canine demonstrates earlier and greater improvement in emotion dysregulation than Regulating ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11922239/

A randomized controlled trial of the effects of dog-assisted ... Children who received dog-assisted therapy improved significantly more in terms of emotional attunement and emotion regulation than children in the two other ...

3. withpower.com withpower.com/trial/phase-autism-spectrum-disorder-1-2023-a6226

Therapy Dogs + Behavioral Treatment for Autism 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 ...

4. autismsciencefoundation.org autismsciencefoundation.org/participate_research/autism-intervention-for-emotion-regulation-with-canines/

Autism Intervention for Emotion Regulation with Canines What's the study about? Our canine study is aimed to learn more about Regulating Together and canine assisted therapy for 8-15 year olds with autism spectrum ...

5. researchgate.net researchgate.net/publication/393251591_The_effect_of_Animal-assisted_therapy_on_prosocial_behavior_and_emotional_regulation_in_autistic_children_with_varying_verbal_abilities_A_pilot_study

The effect of Animal-assisted therapy on prosocial behavior ... A total of 2,281 interactions and behaviors occurring during AAT sessions were examined. Results Both groups interacted well with the canine.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05803343

Evaluating Additive Effects of Including Canines in ... RT-C is an animal assisted, intensive outpatient group intervention for children with autism spectrum disorder and emotion dysregulation. RT-C meets for 1.5 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8907032/

An Evaluation of Animal-Assisted Therapy for Autism ... The aim of this phenomenological study was to gain a better understanding of the therapists and parents of individuals who choose the alternative approach, AAT.