NCT05788783

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 Lawrence Hall, a Chicago-based residential treatment center for maltreated youth. In this study, the investigators test the feasibility, acceptability, and short-term efficacy of expanding the program to a group of youth currently in outpatient treatment for social, emotional, and behavioral problems. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 29, 2023

Completed
11 months until next milestone

Study Start

First participant enrolled

February 26, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 21, 2025

Status Verified

March 1, 2025

Enrollment Period

1.8 years

First QC Date

January 30, 2023

Last Update Submit

August 15, 2025

Conditions

Outcome Measures

Primary Outcomes (7)

  • Emotional Stroop

    Computer-Assisted task assessing affect regulation

    Up to 1-month post-intervention

  • Change in Emotional Stroop

    Computer-Assisted task assessing affect regulation

    Change from baseline to up to 1-month post-intervention

  • Flanker Task

    Computer-Assisted task assessing attention \& inhibitory control

    Up to 1-month post-intervention

  • Change in Flanker Task

    Computer-Assisted task assessing attention \& inhibitory control

    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

    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

    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.

    Change from the beginning to the end of each of the 6 weekly intervention sessions

Secondary Outcomes (8)

  • Pearson Social Skills Rating Scales -Positive social behaviors

    Up to 1-month post-intervention

  • Change in Pearson Social Skills Rating Scales -Positive social behaviors

    Change from baseline to up to 1-month post-intervention

  • Pearson Social Skills Rating Scales -Externalizing behaviors

    Up to 1-month post-intervention

  • Change in Pearson Social Skills Rating Scales -Externalizing behaviors

    Change from baseline to up to 1-month post-intervention

  • Attendance and Attrition

    Aggregated across the 6-week intervention program

  • +3 more secondary outcomes

Study Arms (2)

Experimental

EXPERIMENTAL

Active intervention. Youth will be assigned to the active Recovery \& Care Canine-Assisted Therapy intervention arm.

Behavioral: Recovery & Care Canine-Assisted Therapy

Active control

OTHER

Active control intervention. Youth will be assigned to the active Canine Education \& Bonding arm.

Other: Canine Education & Bonding

Interventions

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.

Experimental

Active control intervention. An 6-week session of semi-structured activities. Sessions are 45 minutes in length. Youth in this condition engage in an educational component, passive observation of dog-training skills, and an active free-play session with the dog-handler teams.

Active control

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Currently receiving outpatient mental health services at the University of Chicago or have received outpatient mental health services from the community in the last 12 months.
  • Available for scheduling during the entire 6-week intervention program
  • Interest in participating in the program

You may not qualify if:

  • Severe cognitive, psychiatric, or physical condition or limitation that would prevent participation.
  • Severe animal allergy
  • Animal phobia
  • History of mistreatment of animals.
  • Above-average scores on both measures of behavioral regulation and emotional regulation
  • WASI t-score of intellectual ability \< 60.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Emotional RegulationMental Disorders

Interventions

Salvage Therapy

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Kristen Jacobson, PhD

CONTACT

Jennifer A Ponting

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2023

First Posted

March 29, 2023

Study Start

February 26, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

August 21, 2025

Record last verified: 2025-03

Locations