LH Canine Therapy Study

Emotion Regulation Clinical Trial

Official title:

Evaluating the Impact of a Canine-assisted Therapy Program in Youth Residing in a Residential Treatment Center.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05840198
• Other study ID #: IRB22-1104
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2023
• Est. completion date: August 2024

Study information

• Verified date: August 2023
• Source: University of Chicago
• Contact: Kristen Jacobson, PhD
• Phone: 773-834-0265
• Email: kjacobso[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 Lawrence Hall, a Chicago-based residential treatment center for maltreated youth, in comparison to a matched sample of youth from Lawrence Hall 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.

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. All studies activities take place in Lawrence Hall. Please note that per Lawrence Hall policy, youth are selected by Lawrence Hall staff to participate in the Recovery & Care Canine-Assisted Therapy program while in residence. A group of closely-matched youth will also be selected by Lawrence Hall staff to serve as the waitlist control (treatment-as-usual) group.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• Youth must be receiving in-patient services at Lawrence Hall

• 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.

• WASI scores < 60

Related Conditions & MeSH terms

• Behavioral Disorder
• Emotion Regulation
• Self Esteem

Intervention

Behavioral:
• Recovery & Care Canine-Assisted Therapy
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.

Other:
• Treatment as usual
Youth in this condition receive treatment as usual from their health care providers

Locations

Country	Name	City	State
United States	Lawrence Hall Child & Family Treatment Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Canine Therapy Corps

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emotional Stroop	Computer-Assisted task assessing affect regulation	Up to 1-month post-intervention
Primary	Change in Emotional Stroop	Computer-Assisted task assessing affect regulation	Change from baseline to up to 1-month post-intervention
Primary	Flanker Task	Computer-Assisted task assessing attention & inhibitory control	Up to 1-month post-intervention
Primary	Change in Flanker Task	Computer-Assisted task assessing attention & inhibitory control	Change from baseline to up to 1-month post-intervention
Primary	Rosenberg Self-Esteem Scale	10-item self-report scale assessing self-esteem. Higher scores are better outcomes	Up to 1-month post-intervention
Primary	Change in Rosenberg Self-Esteem Scale	10-item self-report scale assessing self-esteem. Higher scores are better outcomes	Change from baseline to up to 1-month post-intervention
Primary	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.	Change from the beginning to the end of each of the 6 intervention session
Secondary	Attendance and Attrition	Project staff will record the number of absences and drop-outs for youth enrolled in both study intervention conditions.	Aggregated across the 6-week intervention program
Secondary	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.	Change from the beginning to the end of each of the 6 intervention session.
Secondary	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.	Aggregated across the 6-week intervention program
Secondary	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.	Change from baseline to up to 1-month post-intervention