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

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ClinicalTrials.gov Identifier: NCT01594606
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : December 9, 2015
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Annmarie Cano, Wayne State University

Tracking Information
First Submitted Date  ICMJE May 4, 2012
First Posted Date  ICMJE May 9, 2012
Last Update Posted Date December 9, 2015
Study Start Date  ICMJE May 2012
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2012)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Control Trial of an Animal-Assisted Intervention With Adjudicated Youth
Official Title  ICMJE RCT of an Animal-Assisted Intervention With Adjudicated Youth
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Conduct Disorder
  • Depression
  • Anxiety
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Animal-assisted
    This group receives the dog training program in which they will be teaching a dog basic obedience skills.
    Intervention: Behavioral: Animal-assisted intervention
  • Active Comparator: Dog Walking
    This group will walk a different dog each week but will not engage in dog training.
    Intervention: Behavioral: Animal-assisted intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 8, 2015)
150
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2012)
128
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • none
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01594606
Other Study ID Numbers  ICMJE R03HD070621( U.S. NIH Grant/Contract )
R03HD070621 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Annmarie Cano, Wayne State University
Study Sponsor  ICMJE Wayne State University
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Annmarie Cano, PhD Wayne State University
PRS Account Wayne State University
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP