Emotion RegulationNCT05840198
LH Canine Therapy Study
A study testing Recovery & Care Canine-Assisted Therapy and Treatment as usual in people with Emotion Regulation and Behavioral Disorder, run by University of Chicago at 2 sites in United States.
Trial summary
The goal of this pilot project is to test for initial efficacy of the Recovery \& Care Canine-Assisted Therapy program that has been developed and implemented in youth institutionalized for behavioral and emotional problems. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Emotion Regulation, Behavioral Disorder, Self Esteem
- What is being tested?
- Recovery & Care Canine-Assisted Therapy and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 May 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Youth must be receiving in-patient services at Lawrence Hall or Lydia Home
- Youth must provide informed assent.
- Youth must complete at least one of the primary outcomes during the baseline assessment.
- Youth must remain in residential care for the duration of the 6-week intervention.
- Youth assigned to the Recovery \& Care intervention group must attend at least one of the 6 sessions.
Who cannot join
- Severe cognitive, psychiatric, or physical condition or limitation that would prevent participation.
- Severe animal allergy
- Animal phobia
- History of mistreatment of animals.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Lawrence Hall Child & Family Treatment Center
Chicago, Illinois, 60625
Sean McGinnis, MSW, 773-474-0547, smcginnis@lawrencehall.org
- Recruiting
Lydia Home
Evanston, Illinois, 60202
Heidi Flasch, 847-424-5133, hflasch@lydiahome.org
About this study
Official title: Evaluating the Impact of a Canine-assisted Therapy Program in Youth Residing in a Residential Treatment Center.
The goal of this pilot project is to test for initial efficacy of the Recovery \& Care Canine-Assisted Therapy program that has been developed and implemented in youth institutionalized for behavioral and emotional problems. We are using two study sites, Lawrence Hall and Lydia Home, both Chicago-based residential treatment centers for youth with behavioral and emotional problems, many of whom have experienced child maltreatment and trauma. Comparisons will be made to a matched sample of youth from Lawrence Hall and Lydia Home receiving treatment as usual. Results from this project will provide preliminary evidence of whether a structured, goal-oriented intervention program focused on dog training activities has direct impact on increasing youth emotional self-regulation, impulse control, and self-efficacy, which are important targets for intervention among youth with mental health problems. If successful, this project could lead to a larger, randomized control clinical trials study that tests the longitudinal impact of the program that could further lead to national dissemination of the Recovery \& Care curriculum as an alternative therapeutic approach.
Read the detailed description
The study uses a longitudinal, within-person design with two parallel conditions. In one condition, youth receive a 6-week canine therapy intervention. The other condition consists of treatment as usual. The subject population are youth that are in a full-time residential treatment facility in Lawrence Hall and Lydia Home.
The Recovery \& Care Canine-Assisted Therapy intervention is a 1.25 hour structured curriculum that will occur weekly across a period of 6 weeks. The program will be delivered by the Canine Therapy Corps (CTCorps). Youth will work with CTC-affiliate staff, including trained dog-handler teams, a canine behavior expert, and a clinical supervisor to engage in a series of structured activities progress throughout the intervention. Week 1 is a "meet-and-greet" session where youth are introduced to all dog-handler teams participating in the program and will be asked to select a team to work with for the following sessions. Each youth is assigned their own dog-handler team. Weeks 2 cover activities regarding dog obedience, building from mastering basic commands which the dog already knows (such as "sit," "stay'") to the introduction of "new tricks" that the dog has not yet learned. In Weeks 3, youth will continue to work on mastering the "new tricks" with their dog-handler team and will also begin dog agility training. The agility training session progress in terms of complexity of number and types of obstacles. Week 4 is for proofing all skills (obedience, trick, agility) learned in previous sessions. Week 5 continues proofing all skills and is discussion of the graduation structure and dress rehearsal, and Week 6 is a graduation ceremony where family and friends are invited to observe the progress each youth has made with their dog-handler team. In Weeks 1-5, the goals of each session are outlined at the beginning of the session and brief education is provided regarding the session goals. Weeks 2-5 also include a review of the skills/activities covered in prior weeks. At the end of sessions 1-5, youth are asked to reflect on what they did during the session, including discussion of what they did really well, what they wanted to work on further, and goals for the next session. Research staff will be present during all sessions to record fidelity measures. The Positive and Negative Affect Scale will be administered on-site by research staff at the beginning and end of each intervention session. Change in affect are primary and secondary outcome measures.
Baseline and Follow-up data will be collected up to 1-month before and 1-month after the intervention programs from both the treatment and control groups.
- Conditions
- Emotion Regulation, Behavioral Disorder, Self Esteem
- Being tested
- Recovery & Care Canine-Assisted Therapy, Treatment as usual
- Medical subject headings
- Emotional Regulation, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovery & Care Canine-Assisted TherapyBehavioural
Active intervention. An 6-week session of structured, goal-oriented activities where youth focus on mastering dog obedience and dog training skills. Each session is 1 hour and 15 minutes in length and includes education, review of prior sessions, and specific skill-building activities. Skill-building activities progress in complexity during the course of the 6-week curriculum.
Treatment as usualOther
Youth in this condition receive treatment as usual from their health care providers
| Study group | Role | What they receive |
|---|---|---|
| Active intervention | Experimental | Half of youth will be assigned to the active Recovery \& Care Canine-Assisted Therapy intervention arm. Receives: Behavioral: Recovery & Care Canine-Assisted Therapy |
| Waitlist control | Other | Half of youth will receive treatment as usual. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional Stroop
Computer-Assisted task assessing affect regulation
Measured: Up to 1-month post-intervention
Change in Emotional Stroop
Computer-Assisted task assessing affect regulation
Measured: Change from baseline to up to 1-month post-intervention
Flanker Task
Computer-Assisted task assessing attention \& inhibitory control
Measured: Up to 1-month post-intervention
Change in Flanker Task
Computer-Assisted task assessing attention \& inhibitory control
Measured: Change from baseline to up to 1-month post-intervention
Rosenberg Self-Esteem Scale
10-item self-report scale assessing self-esteem. Higher scores are better outcomes
Measured: Up to 1-month post-intervention
Change in Rosenberg Self-Esteem Scale
10-item self-report scale assessing self-esteem. Higher scores are better outcomes
Measured: Change from baseline to up to 1-month post-intervention
Change in Negative Affect
In addition to overall change in outcomes post intervention, we are also interested in whether each intervention session produces an immediate change in youth emotion. We will assess negative affect using 5 self-report items on current mood from positive and negative affect scale. Higher scores are worse outcomes.
Measured: Change from the beginning to the end of each of the 6 intervention session
Secondary outcomes (4)
Attendance and Attrition
Project staff will record the number of absences and drop-outs for youth enrolled in both study intervention conditions.
Measured: Aggregated across the 6-week intervention program
Change in Positive Affect
In addition to overall change in outcomes post intervention, we are also interested in whether each intervention session produces an immediate change in youth emotion. We will assess positive affect using 5 self-report items on current mood from positive and negative affect scale. Higher scores are better outcomes.
Measured: Change from the beginning to the end of each of the 6 intervention session.
Significant Event Report
Mandated reporting of disruptive behaviors (including offenses, aggression, running away, etc.) and disciplinary actions that occur during the course of the youth's placement at Lawrence Hall.
Measured: Aggregated across the 6-week intervention program
Change in Attitudes towards Pets
Pet-Attitudes Survey-Modified (PAS-M) is a validated, reliable 18-item instrument used to assess youth attitudes towards pets. The PAS-M will be used to determine whether the Recovery \& Care intervention improves attitudes towards pets and/or whether the intervention is effective for all youth. Higher scores indicate a more positive attitude.
Measured: Change from baseline to up to 1-month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start24 May 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotion RegulationStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Canine Therapy Corps
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840198
- Sponsor's protocol ID
- IRB22-1104
- Status last verified
- Mar 2025
- First submitted
- 21 Apr 2023
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of a Canine-assisted Therapy Program in Youth Residing in a Residential Treatment Center.
- ClinicalTrials.gov ID
- NCT05840198
- Acronym / sponsor ID
- IRB22-1104
- Conditions
- Emotion Regulation, Behavioral Disorder, Self Esteem
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Canine Therapy Corps
- Study start
- 24 May 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot project is to test for initial efficacy of the Recovery \& Care Canine-Assisted Therapy program that has been developed and implemented in youth institutionalized for behavioral and emotional problems. We are using two study sites, Lawrence Hall and Lydia Home, both Chicago-based residential treatment centers for youth with behavioral and emotional problems, many of whom have experienced child maltreatment and trauma. Comparisons will be made to a matched sample of youth from Lawrence Hall and Lydia Home receiving treatment as usual. Results from this project will provide preliminary evidence of whether a structured, goal-oriented intervention program focused on dog training activities has direct impact on increasing youth emotional self-regulation, impulse control, and self-efficacy, which are important targets for intervention among youth with mental health problems. If successful, this project could lead to a larger, randomized control clinical trials study that tests the longitudinal impact of the program that could further lead to national dissemination of the Recovery \& Care curriculum as an alternative therapeutic approach.
Detailed description
The study uses a longitudinal, within-person design with two parallel conditions. In one condition, youth receive a 6-week canine therapy intervention. The other condition consists of treatment as usual. The subject population are youth that are in a full-time residential treatment facility in Lawrence Hall and Lydia Home.
The Recovery \& Care Canine-Assisted Therapy intervention is a 1.25 hour structured curriculum that will occur weekly across a period of 6 weeks. The program will be delivered by the Canine Therapy Corps (CTCorps). Youth will work with CTC-affiliate staff, including trained dog-handler teams, a canine behavior expert, and a clinical supervisor to engage in a series of structured activities progress throughout the intervention. Week 1 is a "meet-and-greet" session where youth are introduced to all dog-handler teams participating in the program and will be asked to select a team to work with for the following sessions. Each youth is assigned their own dog-handler team. Weeks 2 cover activities regarding dog obedience, building from mastering basic commands which the dog already knows (such as "sit," "stay'") to the introduction of "new tricks" that the dog has not yet learned. In Weeks 3, youth will continue to work on mastering the "new tricks" with their dog-handler team and will also begin dog agility training. The agility training session progress in terms of complexity of number and types of obstacles. Week 4 is for proofing all skills (obedience, trick, agility) learned in previous sessions. Week 5 continues proofing all skills and is discussion of the graduation structure and dress rehearsal, and Week 6 is a graduation ceremony where family and friends are invited to observe the progress each youth has made with their dog-handler team. In Weeks 1-5, the goals of each session are outlined at the beginning of the session and brief education is provided regarding the session goals. Weeks 2-5 also include a review of the skills/activities covered in prior weeks. At the end of sessions 1-5, youth are asked to reflect on what they did during the session, including discussion of what they did really well, what they wanted to work on further, and goals for the next session. Research staff will be present during all sessions to record fidelity measures. The Positive and Negative Affect Scale will be administered on-site by research staff at the beginning and end of each intervention session. Change in affect are primary and secondary outcome measures.
Baseline and Follow-up data will be collected up to 1-month before and 1-month after the intervention programs from both the treatment and control groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active intervention | Experimental | Behavioral: Recovery & Care Canine-Assisted TherapyHalf of youth will be assigned to the active Recovery \& Care Canine-Assisted Therapy intervention arm. |
| Waitlist control | Other | Other: Treatment as usualHalf of youth will receive treatment as usual. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Youth must be receiving in-patient services at Lawrence Hall or Lydia Home
- Youth must provide informed assent.
- Youth must complete at least one of the primary outcomes during the baseline assessment.
- Youth must remain in residential care for the duration of the 6-week intervention.
- Youth assigned to the Recovery \& Care intervention group must attend at least one of the 6 sessions.
Key exclusion criteria (4 listed)
- Severe cognitive, psychiatric, or physical condition or limitation that would prevent participation.
- Severe animal allergy
- Animal phobia
- History of mistreatment of animals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recovery & Care Canine-Assisted TherapyActive intervention. An 6-week session of structured, goal-oriented activities where youth focus on mastering dog obedience and dog training skills. Each session is 1 hour and 15 minutes in length and includes education, review of prior sessions, and specific skill-building activities. Skill-building activities progress in complexity during the course of the 6-week curriculum. | Behavioural | Active intervention |
| Treatment as usualYouth in this condition receive treatment as usual from their health care providers | Other | Waitlist control |
Primary outcome
Emotional Stroop
Time frame: Up to 1-month post-intervention
Computer-Assisted task assessing affect regulation
Change in Emotional Stroop
Time frame: Change from baseline to up to 1-month post-intervention
Computer-Assisted task assessing affect regulation
Flanker Task
Time frame: Up to 1-month post-intervention
Computer-Assisted task assessing attention \& inhibitory control
Change in Flanker Task
Time frame: Change from baseline to up to 1-month post-intervention
Computer-Assisted task assessing attention \& inhibitory control
Rosenberg Self-Esteem Scale
Time frame: Up to 1-month post-intervention
10-item self-report scale assessing self-esteem. Higher scores are better outcomes
Change in Rosenberg Self-Esteem Scale
Time frame: Change from baseline to up to 1-month post-intervention
10-item self-report scale assessing self-esteem. Higher scores are better outcomes
Change in Negative Affect
Time frame: Change from the beginning to the end of each of the 6 intervention session
In addition to overall change in outcomes post intervention, we are also interested in whether each intervention session produces an immediate change in youth emotion. We will assess negative affect using 5 self-report items on current mood from positive and negative affect scale. Higher scores are worse outcomes.
4 secondary outcomes
Attendance and Attrition
Time frame: Aggregated across the 6-week intervention program
Change in Positive Affect
Time frame: Change from the beginning to the end of each of the 6 intervention session.
Significant Event Report
Time frame: Aggregated across the 6-week intervention program
Change in Attitudes towards Pets
Time frame: Change from baseline to up to 1-month post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recovery & Care Canine-Assisted Therapy and Treatment as usual in people with Emotion Regulation and Behavioral Disorder, run by University of Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristen Jacobson, PhD (773-834-0265, kjacobso@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotional Stroop (time frame: Up to 1-month post-intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.