Integrating Animal-Assisted Therapy Into Trauma-Focused Cognitive-Behavioral Therapy for Maltreated Youth (TF-CBT+AAT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03135119|
Recruitment Status : Active, not recruiting
First Posted : May 1, 2017
Last Update Posted : March 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Child Abuse Posttraumatic Stress||Behavioral: TF-CBT Behavioral: TF-CBT+AAT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||All individuals collecting and/or handling data will be masked.|
|Official Title:||Integrating Animal-Assisted Therapy Into Trauma-Focused Cognitive-Behavioral Therapy for Maltreated Youth: A Randomized Feasibility Trial|
|Actual Study Start Date :||November 15, 2017|
|Estimated Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||April 30, 2020|
Active Comparator: TF-CBT
Youth will receive standard Trauma-Focused Cognitive-Behavioral Therapy
TF-CBT is typically described as including 3 phases, each focusing on a common goal and encompassing a third of treatment (4 sessions). The first phase focuses on skills-building and includes psychoeducation, parenting skills training, relaxation skills training, affect modulation skills training, and cognitive coping skills training. The second phase involves focused gradual exposure activities, including construction of a narrative account of the child's maltreatment experiences and cognitive processing of maladaptive thoughts. The third phase emphasizes the child's mastery over environmental reminders of the maltreatment and includes sharing the trauma narrative with the caregiver, in vivo exposure to physical stimuli, and enhancing future development.
Youth will received Trauma-Focused Cognitive-Behavioral Therapy with Animal-Assisted Therapy as an adjunct.
TF-CBT, as described in the other arm, with animal-assisted therapy as an adjunct intervention. During the administration of TF-CBT, a certified service dog will be in the room and the participant may elect to interact with the dog as various points throughout the sessions.
- Change in scores on the UCLA PTSD Reaction Index for DSM-5 [ Time Frame: Week 1, week 5, week 9, week 13 ]A caregiver and self-report version of the form to assess posttraumatic stress
- Change in scores on the Strengths and Difficulties Questionnaire [ Time Frame: Week 1, week 5, week 9, week 13 ]A caregiver report measure of youth's emotional concerns, behavioral problems, and social skills
- Change in scores on the Screen for Child Anxiety Related Disorders [ Time Frame: Week 1, week 5, week 9, week 13 ]A youth self-report measure of anxiety symptoms
- Change in scores on the Moods and Feelings Questionnaire [ Time Frame: Week 1, week 5, week 9, week 13 ]A youth self-report measure of depression symptoms
- Change in scores on the Emotion Regulation Checklist [ Time Frame: Week 1, week 13 ]A caregiver report measure of a youth's ability to regulate emotions
- Change in scores on the Emotion Regulation Index for Children and Adolescents [ Time Frame: Week 1, week 13 ]A youth self-report measure of a youth's ability to regulate emotions
- Change in physiological stress response [ Time Frame: All weeks 1 - 13 ]Stress response will be measured in response to a defined stressor (Trier Social Stress Task) and during session.
- Change in scores on the Therapeutic Alliance Scale for Children [ Time Frame: Week 2, week 4, week 13 ]A youth and caregiver-report measure that assesses perception of the quality of therapeutic rapport.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03135119
|United States, Pennsylvania|
|Penn State Hershey Medical Center-TLC Research and Treatment Center|
|Harrisburg, Pennsylvania, United States, 17110|
|Principal Investigator:||Brian Allen||Penn State College of Medicine|