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Randomized Control Trial of an Animal-Assisted Intervention With Adjudicated Youth

Primary Purpose

Conduct Disorder, Depression, Anxiety

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Animal-assisted intervention
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Conduct Disorder focused on measuring Animal-assisted intervention, adjudicated adolescents, empathy

Eligibility Criteria

14 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • must be a resident of participating juvenile justice center in Michigan

Exclusion Criteria:

  • none

Sites / Locations

  • Macomb County Juvenile Justice Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Animal-assisted

Dog Walking

Arm Description

This group receives the dog training program in which they will be teaching a dog basic obedience skills.

This group will walk a different dog each week but will not engage in dog training.

Outcomes

Primary Outcome Measures

Change in Internalizing and Externalizing Symptoms as measured by the Achenbach Child Behavior Checklist-Teacher Report and Youth Self Report forms
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.

Secondary Outcome Measures

Change in empathy toward other people
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.

Full Information

First Posted
May 4, 2012
Last Updated
December 8, 2015
Sponsor
Wayne State University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT01594606
Brief Title
Randomized Control Trial of an Animal-Assisted Intervention With Adjudicated Youth
Official Title
RCT of an Animal-Assisted Intervention With Adjudicated Youth
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conduct Disorder, Depression, Anxiety
Keywords
Animal-assisted intervention, adjudicated adolescents, empathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Animal-assisted
Arm Type
Experimental
Arm Description
This group receives the dog training program in which they will be teaching a dog basic obedience skills.
Arm Title
Dog Walking
Arm Type
Active Comparator
Arm Description
This group will walk a different dog each week but will not engage in dog training.
Intervention Type
Behavioral
Intervention Name(s)
Animal-assisted intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Internalizing and Externalizing Symptoms as measured by the Achenbach Child Behavior Checklist-Teacher Report and Youth Self Report forms
Description
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.
Time Frame
baseline and 10 weeks
Secondary Outcome Measure Information:
Title
Change in empathy toward other people
Description
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.
Time Frame
baseline and 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: must be a resident of participating juvenile justice center in Michigan Exclusion Criteria: none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annmarie Cano, PhD
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Macomb County Juvenile Justice Center
City
Mt. Clemens
State/Province
Michigan
ZIP/Postal Code
48043
Country
United States

12. IPD Sharing Statement

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Randomized Control Trial of an Animal-Assisted Intervention With Adjudicated Youth

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