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

• Sponsor: Milton S. Hershey Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03135119
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 33
• Location: 1
• Arms: 2
• Actual Duration (Months): 28.1
• Patients Per Site Per Month: 1.2

Study Details

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	N/A

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
• 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: Nov 15, 2017
• Actual Primary Completion Date: Mar 18, 2020
• Actual Study Completion Date: Mar 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 [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 [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 [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 [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

Criteria

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

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

	Site	City	State	Country	Postal Code
1	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)

• Study Protocol and Statistical Analysis Plan - May 16, 2022

More Information

Publications

None provided.

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

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Recruitment Details	Youth were recruited to participate in this study, although caregivers are necessary to complete the treatment protocol and caregiver-report was a primary method of evaluating outcome. No measures were collected on caregiver functioning or outcomes. Recruitment numbers and outcomes are strictly related to the youth participants.

Arm/Group Title	TF-CBT	TF-CBT+AAT
Arm/Group Description	Youth will receive standard Trauma-Focused Cognitive-Behavioral Therapy 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.	Youth will received Trauma-Focused Cognitive-Behavioral Therapy with Animal-Assisted Therapy as an adjunct. 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.
Period Title: Overall Study
STARTED	16	17
COMPLETED	11	14
NOT COMPLETED	5	3

Baseline Characteristics

Arm/Group Title	TF-CBT	TF-CBT+AAT	Total
Arm/Group Description	Youth will receive standard Trauma-Focused Cognitive-Behavioral Therapy 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.	Youth will received Trauma-Focused Cognitive-Behavioral Therapy with Animal-Assisted Therapy as an adjunct. 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.	Total of all reporting groups
Overall Participants	16	17	33
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	11.56 (3.35)	12.0 (2.89)	11.79 (3.08)
Sex: Female, Male (Count of Participants)
Female	5 31.3%	6 35.3%	11 33.3%
Male	11 68.8%	11 64.7%	22 66.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 25%	3 17.6%	7 21.2%
Not Hispanic or Latino	12 75%	14 82.4%	26 78.8%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 25%	3 17.6%	7 21.2%
White	9 56.3%	12 70.6%	21 63.6%
More than one race	3 18.8%	2 11.8%	5 15.2%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Change in Scores on the UCLA Posttraumatic Stress Disorder Reaction Index
Description	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.
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TF-CBT	TF-CBT+AAT
Arm/Group Description	Youth will receive standard Trauma-Focused Cognitive-Behavioral Therapy 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.	Youth will received Trauma-Focused Cognitive-Behavioral Therapy with Animal-Assisted Therapy as an adjunct. 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.
Measure Participants	16	17
Pre-treatment	44.63 (12.38)	39.5 (18.44)
Post-treatment	22.64 (16.43)	35.85 (14.81)

2. Secondary Outcome

Title	Change in Scores on the Strengths and Difficulties Questionnaire Emotional Symptoms Subscale
Description	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.
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TF-CBT	TF-CBT+AAT
Arm/Group Description	Youth will receive standard Trauma-Focused Cognitive-Behavioral Therapy 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.	Youth will received Trauma-Focused Cognitive-Behavioral Therapy with Animal-Assisted Therapy as an adjunct. 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.
Measure Participants	16	17
Pre-treatment	6.5 (2.58)	7.65 (2.0)
Post-treatment	4.0 (3.0)	5.08 (1.85)

3. Secondary Outcome

Title	Change in Scores on the Screen for Child Anxiety Related Disorders
Description	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.
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TF-CBT	TF-CBT+AAT
Arm/Group Description	Youth will receive standard Trauma-Focused Cognitive-Behavioral Therapy 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.	Youth will received Trauma-Focused Cognitive-Behavioral Therapy with Animal-Assisted Therapy as an adjunct. 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.
Measure Participants	16	17
Pre-treatment	39.64 (18.04)	35.47 (14.45)
Post-treatment	25.45 (19.17)	31.62 (14.94)

4. Secondary Outcome

Title	Change in Scores on the Moods and Feelings Questionnaire
Description	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. .
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TF-CBT	TF-CBT+AAT
Arm/Group Description	Youth will receive standard Trauma-Focused Cognitive-Behavioral Therapy 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.	Youth will received Trauma-Focused Cognitive-Behavioral Therapy with Animal-Assisted Therapy as an adjunct. 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.
Measure Participants	16	17
Pre-treatment	9.13 (5.6)	8.88 (4.69)
Post-treatment	5.91 (5.54)	8.85 (6.12)

Adverse Events

Time Frame	Adverse events were monitored over the course of the participant's participation in the study, which ran from the first assessment (i.e., pre-treatment) to their final attendance at a study related function (e.g., last treatment session attended, post-treatment assessment; **up to 13 weeks**)
Arm/Group Title	TF-CBT		TF-CBT+AAT
Arm/Group Description	Youth will receive standard Trauma-Focused Cognitive-Behavioral Therapy 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.		Youth will received Trauma-Focused Cognitive-Behavioral Therapy with Animal-Assisted Therapy as an adjunct. 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.
All Cause Mortality
	TF-CBT		TF-CBT+AAT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/17 (0%)
Serious Adverse Events
	TF-CBT		TF-CBT+AAT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	TF-CBT		TF-CBT+AAT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/17 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.