- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01594606
Randomized Control Trial of an Animal-Assisted Intervention With Adjudicated Youth
December 8, 2015 updated by: Annmarie Cano, Wayne State University
RCT of an Animal-Assisted Intervention With Adjudicated Youth
The project involves testing the efficacy of an animal-assisted intervention (AAI).
The AAI consists of a 10-week program in which adjudicated adolescents train shelter dogs and will be compared to a dog walking control group matched for educational content and dog contact time.
The investigators expect that the AAI will result in improved empathy skills and that dog attachment will explain these findings.
The investigators also explore the extent to which the AAI will improve internalizing and externalizing symptoms in these adolescents.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Adjudicated adolescents (i.e., teens who have committed criminal offenses and are incarcerated in juvenile detention centers) have deficits in emotion regulation, including empathy skills, and are at risk for a host of poor outcomes including repeat offenses, internalizing symptoms (e.g., depression, anxiety), externalizing symptoms (e.g., lying, truancy, fighting).
Many of these problems stem from a lack of secure attachment to parents and peers.
There is a need for novel and innovative programs to help these teens develop more secure attachments and better empathy skills to prevent poor outcomes.
One type of intervention is animal-assisted interventions such as dog training programs.
These programs appear to build empathy skills in at-risk youth, which may translate into better peer relations, less psychological distress, and less recidivism.
The goal of this study is to test an existing animal-assisted intervention program that is already being used in juvenile detention centers to determine whether it is efficacious in improving adjudicated adolescents' empathy skills and psychological symptoms through building a secure attachment to the training dog.
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Mt. Clemens, Michigan, United States, 48043
- Macomb County Juvenile Justice Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- must be a resident of participating juvenile justice center in Michigan
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Animal-assisted
This group receives the dog training program in which they will be teaching a dog basic obedience skills.
|
The experimental group will receive 10 weeks of classroom training and hands-on experience working with dogs to teach them basic obedience skills.
Each participant will work with the same dog each week.
The active control group will receive 10 weeks of classroom training and will walk a different dog each week but will not teach obedience skills to the dogs.
|
|
Active Comparator: Dog Walking
This group will walk a different dog each week but will not engage in dog training.
|
The experimental group will receive 10 weeks of classroom training and hands-on experience working with dogs to teach them basic obedience skills.
Each participant will work with the same dog each week.
The active control group will receive 10 weeks of classroom training and will walk a different dog each week but will not teach obedience skills to the dogs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Internalizing and Externalizing Symptoms as measured by the Achenbach Child Behavior Checklist-Teacher Report and Youth Self Report forms
Time Frame: baseline and 10 weeks
|
The Achenbach Child Behavior Checklist is a standardized measure of child behavior problems that assesses observers' and children's reports of the children's anxiety and depression (internalizing) and acting out (externalizing) behaviors.
|
baseline and 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in empathy toward other people
Time Frame: baseline and 10 weeks
|
An observational measure was created for the purposes of this study in which a trained confederate acts as a potential student for the animal-assisted intervention.
The confederate will express anxiety about the program and the participants' responses will be coded by trained raters for empathic content.
|
baseline and 10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Annmarie Cano, PhD, Wayne State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
May 4, 2012
First Submitted That Met QC Criteria
May 8, 2012
First Posted (Estimate)
May 9, 2012
Study Record Updates
Last Update Posted (Estimate)
December 9, 2015
Last Update Submitted That Met QC Criteria
December 8, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R03HD070621 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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