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

Depression Clinical Trial

Official title:

RCT of an Animal-Assisted Intervention With Adjudicated Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01594606
• Other study ID #: R03HD070621
• Secondary ID: R03HD070621
• Status: Completed
• Phase: Phase 3
• First received: May 4, 2012
• Last updated: December 8, 2015
• Start date: May 2012
• Est. completion date: June 2015

Study information

• Verified date: December 2015
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 17 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Conduct Disorder
• Depression

Intervention

Behavioral:
• Animal-assisted intervention
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.

Locations

Country	Name	City	State
United States	Macomb County Juvenile Justice Center	Mt. Clemens	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Wayne State University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline and 10 weeks	No
Secondary	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.	baseline and 10 weeks	No