Integrating Animal-Assisted Therapy Into Trauma-Focused Cognitive-Behavioral Therapy for Maltreated Youth

NCT03135119 | Completed Results DMC

• 2 other identifiers: STUDY00006612R21HD091887
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Abuse; Posttraumatic Stress

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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.

Study Arms (2)

TF-CBT

ACTIVE COMPARATOR

Youth will receive standard Trauma-Focused Cognitive-Behavioral Therapy

Behavioral: TF-CBT

TF-CBT+AAT

EXPERIMENTAL

Youth will received Trauma-Focused Cognitive-Behavioral Therapy with Animal-Assisted Therapy as an adjunct.

Behavioral: TF-CBT+AAT

Interventions

TF-CBT BEHAVIORAL

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

TF-CBT+AAT BEHAVIORAL

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.

TF-CBT+AAT

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Penn State Hershey Medical Center-TLC Research and Treatment Center

Harrisburg, Pennsylvania, 17110, United States

Location

Related Publications (1)

• 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.

  PMID: 35689729 DERIVED

Results Point of Contact

• Title: Dr. Brian Allen
• Organization: Penn State College of Medicine

ballen1@pennstatehealth.psu.edu

7175314100

Study Officials

• Brian Allen

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All individuals collecting and/or handling data will be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Pediatrics

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: May 1, 2017
• Study Start: November 15, 2017
• Primary Completion: March 18, 2020
• Study Completion: March 18, 2020
• Last Updated: May 18, 2022
• Results First Posted: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (1)