Clinical trial NCT04610346: Assessing an Animal-Assisted Treatment Program for Adults With Aphasia: The Persons With Aphasia Training Dogs Program
Official title: Assessing an Animal-Assisted Treatment Program for Adults With Aphasia: The Persons With Aphasia Training Dogs Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Keywords: aphasia
animal-assisted therapy
Lead sponsor: Albert Einstein Healthcare Network
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-10-30
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to one of two study arms, immediate or delayed treatment.
Primary purpose: TREATMENT

Brief summary: The lives of more than 2 million Americans are affected by aphasia, an acquired language impairment most commonly resulting from stroke that affects the ability to remember and express words. The well-being of these individuals is affected not just by the loss of words that is aphasia, but also the loss of friendships and opportunities for community engagement in which the loss of words can result. This study evaluates an animal-assisted treatment, The Persons with Aphasia Training Dogs (PATD) Program, designed to target the psychosocial consequences of aphasia by training participants in positive reinforcement dog training techniques that harness new skill learning and the advantages of interaction with family- or shelter-dwelling dogs to increase confidence and social engagement to support participants in living well with aphasia.

Detailed description: Our long-term goals are to evaluate the effectiveness of canine- assisted therapy for persons with aphasia and to operationalize aphasia treatments targeting psychosocial consequences of aphasia such that they may be implemented with fidelity across clinical settings. The overall objective of this application is to determine the feasibility and impact of a canine-assisted therapy program, the Persons with Aphasia Training Dogs (PATD) Program. This feasibility study, a crucial first step toward our long-term goals, will evaluate participants' ability to learn positive reinforcement dog training techniques, and provide data regarding the impact of treatment with respect to feasibility metrics associated with recruitment, retention, compliance, and importantly, program satisfaction/acceptability. The hypotheses are that PWA are able to learn positive reinforcement techniques to apply to dog training and that retention, compliance, and program satisfaction rates for this canine-assisted treatment will be high, with program satisfaction linked to psychosocial benefits such as increased self-confidence and social engagement for PWA. These hypotheses have been formulated on the basis of the PI's funded work designing and implementing the PATD program for the MossRehab Aphasia Center, as well as work in aphasia rehabilitation and canine-assisted interventions, including those with persons with aphasia. Accomplishment of the overall objective of this application will be achieved through this small-scale feasibility study aimed to garner preliminary support for our hypotheses and provide data to inform design of a future, large-scale clinical trial.

Specific Aim 1: Determine whether PWA, through participation in the PATD program, can learn and implement positive reinforcement techniques to train dogs in basic obedience skills. Hypothesis 1: On program completion, PWA will be competent in using positive reinforcement techniques, to independently cue a dog to complete a minimum of 4 (of 5) trained obedience skills. To test this hypothesis, participants will be assessed using a PI-adapted version of the Pet Partners© Animal-Handler Evaluation.

Specific Aim 2: Define participant characteristics associated with recruitment, retention, compliance and program acceptability/satisfaction relevant for determining PATD candidacy. Hypothesis 2: PWA will demonstrate high (above 80%) retention and compliance rates, and high program satisfaction, including increases in self-reported ratings of psychosocial well-being. To test this hypothesis, our primary outcome measure will be the Assessment of Living with Aphasia, complemented by self-report of participants' PATD experience gathered through an ALA-modeled qualitative spoken interview and a written, aphasia-friendly, satisfaction survey.

Accomplishment of the overall objective of this application will be achieved through this small-scale, feasibility study aimed to garner preliminary support for our hypotheses and to provide the foundation for a future, large-scale clinical trial.

Specific Aim 1: Determine whether PWA, through participation in the PATD program, can learn and implement positive reinforcement techniques to train dogs in basic obedience skills. Hypothesis 1: On program completion, PWA will be competent in using positive reinforcement techniques, to independently cue a dog to complete a minimum of 4 (of 5) trained obedience skills. To test this hypothesis, program participants will be assessed using a PI-adapted version of the Pet Partners© Animal-Handler Evaluation.

Skills Training: In consultation with a certified professional dog trainer, the PATD program was developed by the PI, a trained speech language-pathologist with eighteen years of experience working with people with aphasia, who has spent more than ten years working with shelter animals using positive reinforcement techniques. Participants enrolled in the PATD program will engage in five once-weekly individual training sessions with the PI, either with a family dog (PATD) or by volunteering at a local shelter, the Pennsylvania SPCA (PATD-PSPCA). PATD-PSPCA participants will work only with dogs that have been evaluated by PSPCA staff as appropriate for interaction with new volunteers. Each session will be dedicated to one of five pre-determined, sequentially-presented, obedience skills (i.e., LOOK, TOUCH, SIT, STAY, COME). Training sessions will last approximately 75 minutes, with an additional half hour allotted to the beginning of the first training session to review principles of positive-reinforcement training. Subsequent sessions will begin with a brief probe of the participant's skill in cueing the dog to perform the behavior trained the previous week. Following the probe, sessions will continue with a review of that week's lesson plan, after which the PI will model the first training step three times. After the model has been provided, the participant will attempt the procedure, receiving instructive feedback or reinforcement from the trainer. Instruction will proceed to the subsequent step when the participant and dog have attained 5 successful trials at the current step. The same demonstration procedure will be used at each subsequent step. Commands will be trained using one hand gesture for each behavior. To mark behaviors, participants will use a clicker attached to a wrist band, which can be hand-held or allowed to dangle for ease of use for those with hemiplegia. Participants will have the option of introducing the verbal command, but will not be required to do so. All participants will be asked to provide their dog with a walk before training sessions to support the dog in being ready to participate.

Skills Practice: Participants will not be required to complete all steps for an obedience skill in a single session, and will be encouraged to practice the skill with the dog for at least 3 practice sessions over the course of the week. Practice will be used as a measure of participant compliance. Each participant will be provided with a copy of the lesson plan and, if interested, a video demonstrating the PI performing the target skill with her own dog. Participants will also be provided with a training log to complete after each time they practice over the course of the week. Using a nine-point visual analog scale adapted from the Assessment of Living with Aphasia (ALA), participants will rate their own and the dog's performance during each practice session. To facilitate responses on the log, participants will be provided with a pictographic list of questions to consider in determining their ratings (e.g., "How many times did I have to cue the dog", "Did I 'click' as soon as the dog did what I asked?".

Specific Aim 2: Define participant characteristics associated with recruitment, retention, compliance and program acceptability/satisfaction relevant for determining PATD candidacy. Hypothesis 2: PWA will demonstrate high (above 80%) retention and compliance rates, and high program satisfaction, including increases in self-reported ratings of psychosocial well-being. To test this hypothesis, the primary outcome measure will be the Assessment of Living with Aphasia, complemented by self-report of participants' PATD experience gathered through an ALA-modeled qualitative spoken interview and a written, aphasia-friendly, satisfaction survey.

Feasibility Metrics: Recruitment rates will be tracked appropriate to the creation of a CONSORT flow diagram including: # contacted, # screened, # eligible (vs. ineligible), # consented/enrolled (vs. declined). To evaluate further the size of the population that may benefit from the treatment, participant screening will include surveying of interest in interaction with dogs and in dog-related activities. Similarly, participant retention rates will be tracked including: # completing baseline assessment, # completing immediate post-treatment assessment, and # completing follow-up assessment. Participant withdrawals will be tracked for whether initiated by researcher or participant. Participant compliance rates will be tracked including # assessment and training sessions (relative to total possible) completed, and # self-reported home practice sessions.

Outcome Measurement: The primary quantitative outcome measure of acceptability, the ALA, is a pictographic self-report measure of quality of life developed to assess the impact of aphasia on daily life. Questions address participants' perceptions of aphasia, their environment, their relationships, their community engagement, experiences of self-confidence and respect, and their progress toward "living well with aphasia". Participants respond by pointing to a visual analog scale, providing for quantification of responses, and rendering the tool accessible to those with language impairment. Overall score and subdomain scores have demonstrated acceptable-to-high test-retest reliability and internal consistency. To augment standardized evaluation, the PI has developed a complementary interview, consistent with the format of the ALA, to more specifically probe PATD participants' perceptions of the impact of the training program. Participant narratives produced during the administration will be supported using interviewing strategies appropriate for persons with aphasia. A written, visual analog scale satisfaction survey designed to adhere to guidelines of 'aphasia-friendly' written materials will also be administered. It is anticipated that the assessment battery will take two hours to complete.

Outcome Measurement/Participation Timeline: Participants will be randomized into immediate and waitlist treatment groups using permuted block randomization with stratification. Analysis between these two arms will be exploratory only in nature, and will inform us regarding the feasibility of the waitlist control design for use in a larger clinical trial. All participants will be evaluated before training begins, immediately following training, and at a 3-month follow-up. Participants in the delayed arm will participate in two pre-training evaluations, one immediately upon enrollment and one at the end of the delay period immediately before beginning training.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of aphasia acquired as the result of cerebro-vascular accident (CVA)
2. English as a native or primary language
3. Evidence of linguistic and cognitive capacity to understand the research requirements
4. Willingness and stamina to participate in the protocol
5. Lives within 1 hour driving distance to MRRI (50 Township Line Rd, Elkins Park, PA 19027 and (as appropriate) PSPCA HQ (350 E. Erie Ave., Philadelphia, PA 19134

Exclusion Criteria:

• Diagnosis of neurological injury or disease other than CVA

Primary outcomes:
measure: Change on Assessment of Living with Aphasia (ALA, Kagan et al., 2010)
timeFrame: Immediate arm: baseline, 6-weeks post baseline, 3 month follow-up; Delayed arm: 2 baselines (6 weeks apart), 6-weeks post 2nd baseline, 3 month follow-up
measure: Change on PI-adapted version of Pet Partners Animal-handler Evaluation.
timeFrame: One observation/week during each of the 6 (once weekly) training sessions, one within 1 week of ending training, one 3 month follow-up
Secondary outcomes:
measure: Change on The Confidence after Stroke Measure (Horne et al., 2017)
timeFrame: Immediate arm: baseline, 6-weeks post baseline, 3 month follow-up; Delayed arm: 2 baselines (6 weeks apart), 6-weeks post 2nd baseline, 3 month follow-up
measure: Change on Behavioural Assessment of Dysexecutive Syndrome (Wilson et al., 1996)
timeFrame: Immediate arm: baseline, 6-weeks post baseline, 3 month follow-up; Delayed arm: 2 baselines (6 weeks apart), 6-weeks post 2nd baseline, 3 month follow-up
Other outcomes:
Locations:
city: Elkins Park
country: United States
facility: Moss Rehabilitation Research Institute
state: Pennsylvania
Study officials:
affiliation: AEHN
name: Sharon M Antonucci, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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