Child AbuseTF-CBT+AATNCT03135119
Integrating Animal-Assisted Therapy Into Trauma-Focused Cognitive-Behavioral Therapy for Maltreated Youth
A study testing TF-CBT and TF-CBT+AAT in people with Child Abuse and Posttraumatic Stress, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Child Abuse, Posttraumatic Stress
- What is being tested?
- TF-CBT and TF-CBT+AAT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2017to 18 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Medical Center-TLC Research and Treatment Center
Harrisburg, Pennsylvania, 17110
About this study
Official title: Integrating Animal-Assisted Therapy Into Trauma-Focused Cognitive-Behavioral Therapy for Maltreated Youth: A Randomized Feasibility Trial
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.
Read the 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.
- Conditions
- Child Abuse, Posttraumatic Stress
- Being tested
- TF-CBT, TF-CBT+AAT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TF-CBTBehavioural
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+AATBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| TF-CBT | Active comparator | Youth will receive standard Trauma-Focused Cognitive-Behavioral Therapy Receives: Behavioral: TF-CBT |
| TF-CBT+AAT | Experimental | Youth will received Trauma-Focused Cognitive-Behavioral Therapy with Animal-Assisted Therapy as an adjunct. Receives: Behavioral: TF-CBT+AAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Scores on the UCLA Posttraumatic Stress Disorder Reaction Index
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.
Measured: 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 (3)
Change in Scores on the Strengths and Difficulties Questionnaire Emotional Symptoms Subscale
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.
Measured: 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.
Change in Scores on the Screen for Child Anxiety Related Disorders
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.
Measured: 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.
Change in Scores on the Moods and Feelings Questionnaire
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. .
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start15 Nov 2017
- Primary completion18 Mar 2020
- Study completion18 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child AbuseStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Brian Allen, Milton S. Hershey Medical Center
- Investigators
- Brian Allen, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135119
- Sponsor's protocol ID
- STUDY00006612
- Other IDs
- R21HD091887
- Acronym
- TF-CBT+AAT
- Status last verified
- May 2022
- First submitted
- 20 Apr 2017
- Last updated
- 18 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Shenk CE, Allen B, Dreschel NA, Wang M, Felt JM, Brown MP, Bucher AM, Chen MJ, Olson AE. Respiratory Sinus Arrhythmia Change during Trauma-Focused Cognitive-Behavioral Therapy: Results from a Randomized Controlled Feasibility Trial. Res Child Adolesc Psychopathol. 2022 Nov;50(11):1487-1499. doi: 10.1007/s10802-022-00946-w. Epub 2022 Jun 11.
PubMed 35689729
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Animal-Assisted Therapy Into Trauma-Focused Cognitive-Behavioral Therapy for Maltreated Youth: A Randomized Feasibility Trial
- ClinicalTrials.gov ID
- NCT03135119
- Acronym / sponsor ID
- TF-CBT+AAT / STUDY00006612
- Conditions
- Child Abuse, Posttraumatic Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 18 Mar 2020 (actual)
- Study completion
- 18 Mar 2020 (actual)
- First posted
- 1 May 2017 (actual)
- Results
- Posted 18 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TF-CBT | Active comparator | Behavioral: TF-CBTYouth will receive standard Trauma-Focused Cognitive-Behavioral Therapy |
| TF-CBT+AAT | Experimental | Behavioral: TF-CBT+AATYouth will received Trauma-Focused Cognitive-Behavioral Therapy with Animal-Assisted Therapy as an adjunct. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TF-CBTTF-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. | Behavioural | TF-CBT |
| TF-CBT+AATTF-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. | Behavioural | TF-CBT+AAT |
Primary outcome
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.
3 secondary outcomes
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35689729Shenk CE, Allen B, Dreschel NA, Wang M, Felt JM, Brown MP, Bucher AM, Chen MJ, Olson AE. Respiratory Sinus Arrhythmia Change during Trauma-Focused Cognitive-Behavioral Therapy: Results from a Randomized Controlled Feasibility Trial. Res Child Adolesc Psychopathol. 2022 Nov;50(11):1487-1499. doi: 10.1007/s10802-022-00946-w. Epub 2022 Jun 11.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Allen principal investigator
Penn State College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TF-CBT and TF-CBT+AAT in people with Child Abuse and Posttraumatic Stress, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03135119, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.