Integrating Animal-Assisted Therapy Into Trauma-Focused Cognitive-Behavioral Therapy for Maltreated Youth (TF-CBT+AAT)

• ClinicalTrials.gov Identifier: NCT03135119
• Recruitment Status: Completed
• First Posted: May 1, 2017
• Results First Posted: May 18, 2022
• Last Update Posted: May 18, 2022
• Sponsor: Milton S. Hershey Medical Center
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by (Responsible Party): Brian Allen, Milton S. Hershey Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Child Abuse; Posttraumatic Stress	Behavioral: TF-CBT; Behavioral: TF-CBT+AAT	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: All individuals collecting and/or handling data will be masked.
• Primary Purpose: Treatment
• 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
• Actual Primary Completion Date: March 18, 2020
• Actual Study Completion Date: March 18, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: TF-CBT; Youth will receive standard Trauma-Focused Cognitive-Behavioral Therapy	Behavioral: TF-CBT; 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.
Experimental: TF-CBT+AAT; Youth will received Trauma-Focused Cognitive-Behavioral Therapy with Animal-Assisted Therapy as an adjunct.	Behavioral: TF-CBT+AAT; 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.

Outcome Measures

Primary Outcome Measures :

1. Change in Scores on the UCLA Posttraumatic Stress Disorder Reaction Index [ Time Frame: 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. ]
   This is a caregiver version of the measure designed to assess child/youth posttraumatic stress disorder (PTSD) symptoms. This is a 27-item questionnaire were the frequency of each item is reported using a scale ranging from 0 (Never) to 4 (Most Days), yielding a potential full scale score ranging from 0 to 108. For inclusion in this study, a score of at least 32 on the pre-treatment administration was required as this score denotes the "borderline" range for the measure. Lower scores indicate fewer PTSD symptoms are present.

Secondary Outcome Measures :

1. Change in Scores on the Strengths and Difficulties Questionnaire Emotional Symptoms Subscale [ Time Frame: 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. ]
   The Strengths and Difficulties Questionnaire (SDQ) is a measure assessing the caregiver's observation of assorted emotional and behavioral concerns. This study utilized the "Emotional Symptoms" subscale, which collectively assesses symptoms of depression and anxiety. The subscale includes 5 items, each scored on a scale ranging from 0 (Never) to 2 (Certainly True). This results in possible total scores ranging from 0 to 10 with higher scores indicating a greater level of concern.
2. Change in Scores on the Screen for Child Anxiety Related Disorders [ Time Frame: 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. ]
   The Screen for Child Anxiety Related Disorders (SCARED) is a 41-item measure where the youth self-reports on concerns related to various forms of anxiety. Answer options range from 0 (Not True or Hardly Ever True) to 2 (Very Often or Very True), resulting in a possible total score between 0 and 82 with higher scores indicating greater concerns.
3. Change in Scores on the Moods and Feelings Questionnaire [ Time Frame: 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. ]
   The Moods and Feelings Questionnaire (MFQ) is a 13-item measure that asks youth to report their own concerns with depression-related symptoms. Each item is answered with a 0 (Not True), 1 (Sometimes Ture), or 2 (True). The items are summed to create a total score that may range from 0 to 26, with higher scores denoting a greater level of depressive symptoms. .

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Pennsylvania

Penn State Hershey Medical Center-TLC Research and Treatment Center

Harrisburg, Pennsylvania, United States, 17110

Sponsors and Collaborators

Milton S. Hershey Medical Center

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

• Principal Investigator: Brian Allen; Penn State College of Medicine

  Study Documents (Full-Text)

Documents provided by Brian Allen, Milton S. Hershey Medical Center:

Study Protocol and Statistical Analysis Plan  [PDF] May 16, 2022

More Information

• Responsible Party: Brian Allen, Associate Professor, Pediatrics, Milton S. Hershey Medical Center
• ClinicalTrials.gov Identifier: NCT03135119
• Other Study ID Numbers: STUDY00006612; R21HD091887 ( U.S. NIH Grant/Contract )
• First Posted: May 1, 2017
• Results First Posted: May 18, 2022
• Last Update Posted: May 18, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The final dataset will be stripped of individual identifiers prior to release for sharing. Data subsets will only be made available to other users under data-sharing agreements that provide for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Those wishing to access the data will need to directly contact the PI to complete the data-sharing agreement.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)
• Time Frame: Data will be available starting in July, 2020, and will remain available for 5 years.

Access Criteria

Access to data will require:

1. a commitment to using the data only for research purposes and not to identify any individual participant;
2. a commitment to securing the data using appropriate computer technology;
3. a commitment to destroying or returning the data after analyses are completed;
4. A letter of approval from an applicable Institutional Review Board; and,
5. A signed data usage agreement.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No