Clinical trial NCT05840198: LH Canine Therapy Study
Official title: Evaluating the Impact of a Canine-assisted Therapy Program in Youth Residing in a Residential Treatment Center.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emotion Regulation
Behavioral Disorder
Self Esteem
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Canine Therapy Corps
First posted: 2023-05-03
Enrollment: 48
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Severe cognitive, psychiatric, or physical condition or limitation that would prevent participation.
* Severe animal allergy
* Animal phobia
* History of mistreatment of animals.

Primary outcomes:
measure: Emotional Stroop
timeFrame: Up to 1-month post-intervention
measure: Change in Emotional Stroop
timeFrame: Change from baseline to up to 1-month post-intervention
measure: Flanker Task
timeFrame: Up to 1-month post-intervention
measure: Change in Flanker Task
timeFrame: Change from baseline to up to 1-month post-intervention
measure: Rosenberg Self-Esteem Scale
timeFrame: Up to 1-month post-intervention
measure: Change in Rosenberg Self-Esteem Scale
timeFrame: Change from baseline to up to 1-month post-intervention
measure: Change in Negative Affect
timeFrame: Change from the beginning to the end of each of the 6 intervention session
Secondary outcomes:
measure: Attendance and Attrition
timeFrame: Aggregated across the 6-week intervention program
measure: Change in Positive Affect
timeFrame: Change from the beginning to the end of each of the 6 intervention session.
measure: Significant Event Report
timeFrame: Aggregated across the 6-week intervention program
measure: Change in Attitudes towards Pets
timeFrame: Change from baseline to up to 1-month post-intervention
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Lawrence Hall Child & Family Treatment Center
state: Illinois
city: Evanston
country: United States
facility: Lydia Home
state: Illinois
Study officials:
References: