Clinical trial NCT03135119: Integrating Animal-Assisted Therapy Into Trauma-Focused Cognitive-Behavioral Therapy for Maltreated Youth
Official title: Integrating Animal-Assisted Therapy Into Trauma-Focused Cognitive-Behavioral Therapy for Maltreated Youth: A Randomized Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Abuse
Posttraumatic Stress
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-05-01
Enrollment: 33
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine the incremental benefit of animal-assisted therapy (AAT) as an adjunct intervention when combined with Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) for the treatment of maltreated youth. In addition, the development of therapeutic rapport and the intensity of stress experienced during treatment sessions will be examined as mediational mechanisms of treatment outcome. This project will help determine whether a larger study to test the beneficial effects of AAT for maltreated youth is feasible and warranted.

Detailed description: The eventual goal of this line of research is to determine whether, and through what mechanisms, Animal-Assisted Therapy (AAT) is beneficial for the treatment of maltreated youth. The current project is a feasibility study to determine if larger clinical trials are warranted. The specific aims of the current study are (1) to examine whether the integration of AAT into standard Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) enhances treatment effectiveness, (2) to evaluate the tolerability and feasibility of AAT when integrated into TF-CBT, and (3) to evaluate hypothesized mediational processes that may explain observed positive effects for the integration of AAT. Maltreated youth may display myriad emotional and behavioral symptoms; prominent among these is posttraumatic stress (PTS). TF-CBT is a well-established evidence-based treatment for PTS and other symptoms subsequent to child maltreatment and, therefore, is a suitable intervention for this trial. Sixty (60) maltreated youth (ages 6-17) displaying elevated PTS will be assigned to receive TF-CBT or TF-CBT+AAT using a blocked randomization procedure. The TF-CBT protocol is the standard twelve 90-minute sessions typically used in research trials. Youth in the TF-CBT+AAT condition will receive the standard protocol with a certified service dog present in the room for each session and the youth will be allowed to interact with the dog during session. A pre-post design will be used to ascertain whether the addition of AAT prompts greater PTS reduction as well as greater improvements in other outcomes, including internalizing symptoms, externalizing symptoms, and emotion regulation. Outcome metrics include caregiver and youth-reported objective measures, and respiratory sinus arrhythmia (RSA) assessed via an electrocardiogram (ECG) during both a resting and stress reactivity paradigm. Feasibility metrics assessed include treatment satisfaction, ability to implement the TF-CBT techniques with a dog in the room, treatment disrupting events attributable to the dogs, and whether the dogs experience significant stress as a result of their participation. Stress experienced by the dog will be determined through RSA, salivary cortisol, and behavioral responses. Two prominent hypotheses regarding the mechanism of effect for AAT will be examined. First, therapeutic rapport will be assessed at multiple increments to determine whether the presence of the dog improved the quality or efficiency of development of rapport. Second, RSA will be recorded for the youth during treatment sessions to determine if the presence of the dog yielded a lower intensity of stress during the sessions. Both therapeutic rapport and level of in-session stress will be examined as mediating variables to determine whether either explained enhanced treatment outcomes. To improve the methodological rigor of the study, data will be collected by research assistants blinded to the youth's treatment condition and the same clinicians will implement both treatment conditions, thereby eliminating clinician-specific effects on outcomes.

Eligibility criteria: Inclusion Criteria:

* A caregiver willing to participate with the youth
* An allegation of child maltreatment investigated by child protective services (CPS) or the police
* A raw score of ≥ 39 (borderline or clinical elevation) on the caregiver- report version of the UCLA PTSD Reaction Index for the DSM-5.

Exclusion Criteria:

* Severe developmental delays and/or psychiatric problems that necessitate a higher level of care for the child. An allegation of child maltreatment investigated by child protective services (CPS) or the police
* Intellectual deficits for the child (IQ \< 80 on a cognitive screener)
* Caregiver inability to complete assessment measures due to psychiatric, cognitive, or other limitation
* The available caregiver is suspected or known to have perpetrated maltreatment
* A fear of dogs, a dog allergy, or any prior history of aggression toward animals for the child and/or caregiver

Primary outcomes:
measure: Change in Scores on the UCLA Posttraumatic Stress Disorder Reaction Index
timeFrame: Data were obtained at pre-treatment and every four weeks thereafter until the protocol was completed, **up to 13 weeks**. The last assessment completed, excluding the pre-treatment assessment, was considered post-treatment.
Secondary outcomes:
measure: Change in Scores on the Strengths and Difficulties Questionnaire Emotional Symptoms Subscale
timeFrame: Data were obtained at pre-treatment and every four weeks thereafter until the protocol was completed, **up to 13 weeks**. The last assessment completed, excluding the pre-treatment assessment, was considered post-treatment.
measure: Change in Scores on the Screen for Child Anxiety Related Disorders
timeFrame: Data were obtained at pre-treatment and every four weeks thereafter until the protocol was completed, **up to 13 weeks**. The last assessment completed, excluding the pre-treatment assessment, was considered post-treatment.
measure: Change in Scores on the Moods and Feelings Questionnaire
timeFrame: Data were obtained at pre-treatment and every four weeks thereafter until the protocol was completed, **up to 13 weeks**. The last assessment completed, excluding the pre-treatment assessment, was considered post-treatment.
Other outcomes:
Locations:
city: Harrisburg
country: United States
facility: Penn State Hershey Medical Center-TLC Research and Treatment Center
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Brian Allen
role: PRINCIPAL_INVESTIGATOR
References: