Integrating Animal-Assisted Therapy Into Trauma-Focused Cognitive-Behavioral Therapy for Maltreated Youth
Condition: Child Abuse; Posttraumatic Stress
Study type: Interventional

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.
    

Intervention name(s): TF-CBT; TF-CBT+AAT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment