Trial Outcomes & Findings for Assessing an Animal-Assisted Treatment Program for Adults With Aphasia: The Persons With Aphasia Training Dogs Program (NCT NCT04610346)

Last Updated: 2025-10-16

Results Overview

The Assessment of Living with Aphasia is a pictographic self-reported measure of quality of life living with aphasia across four domains (aphasia, participation, environment, and personal) and an overall evaluation of how well the participant judges that they are overcoming the 'wall' (obstacle) of aphasia. Participants respond using a visual-analog scale with nine points (0 (minimum), .5, 1, 1.5, 2, 2.5, 3, 3.5, 4 (maximum) with higher values being associated with a better outcome. The total scaled score (0- minimum - 4- maximum) is the sum of the raw scores in each of the four domains divided by the number of questions pertaining to each domain, plus the response to the 'wall' question.

Recruitment status

COMPLETED

Study phase

Target enrollment

17 participants

Primary outcome timeframe

Once within approximately 1 week of the end of training, then once approximately 3 months after end of training

Results posted on

2025-10-16

Participant Flow

Participants consented to participation either with a family dog or at a local animal shelter. People in the shelter dog condition were required to complete volunteer onboarding before beginning study activities. Five people consented to the shelter-dog condition were not able to complete shelter volunteer onboarding. They were withdrawn from the study prior to initiating study activities as they did not have access to a dog.

Participant milestones

Participant milestones
Measure	Immediate Participants in this group will begin the training protocol immediately (within 1 week) after baseline pre-training evaluation is completed.	Delayed 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
Overall Study STARTED	12	5
Overall Study Mid-point (Evaluation Immediately After Training)	9	3
Overall Study COMPLETED	9	3
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Immediate Participants in this group will begin the training protocol immediately (within 1 week) after baseline pre-training evaluation is completed.	Delayed 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
Overall Study Withdrawal by Subject	1	1
Overall Study did not complete shelter onboarding	2	1

Baseline Characteristics

Assessing an Animal-Assisted Treatment Program for Adults With Aphasia: The Persons With Aphasia Training Dogs Program

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Immediate n=9 Participants Participants in this group will begin the training protocol immediately (within 1 week) after baseline pre-training evaluation is completed.	Delayed n=3 Participants 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	Total n=12 Participants Total of all reporting groups
Age, Continuous	62.67 years STANDARD_DEVIATION 8.96 • n=5 Participants	53.33 years STANDARD_DEVIATION 12.1 • n=7 Participants	60.33 years STANDARD_DEVIATION 10.14 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	9 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants
Western Aphasia Battery- Revised (WAB-R)	89.6 units on a scale STANDARD_DEVIATION 10.5 • n=5 Participants	64.5 units on a scale STANDARD_DEVIATION 35.9 • n=7 Participants	83.3 units on a scale STANDARD_DEVIATION 21.1 • n=5 Participants
Assessment of Living with Aphasia (ALA)	2.2 units on a scale STANDARD_DEVIATION 0.6 • n=5 Participants	2.2 units on a scale STANDARD_DEVIATION 0.057 • n=7 Participants	2.2 units on a scale STANDARD_DEVIATION 0.5 • n=5 Participants
Confidence after Stroke Measure (CaSM)	46.9 units on a scale STANDARD_DEVIATION 7.9 • n=5 Participants	52 units on a scale STANDARD_DEVIATION 5.57 • n=7 Participants	48.17 units on a scale STANDARD_DEVIATION 7.52 • n=5 Participants
Behavioural Assessment of Dysexecutive Syndrome (BADS)	13.7 units on a scale STANDARD_DEVIATION 4.2 • n=5 Participants	13 units on a scale STANDARD_DEVIATION 4.6 • n=7 Participants	13.5 units on a scale STANDARD_DEVIATION 4.1 • n=5 Participants

PRIMARY outcome

Timeframe: Once within approximately 1 week of the end of training, then once approximately 3 months after end of training

Outcome measures

Outcome measures
Measure	Immediate n=9 Participants Participants in this group will begin the training protocol immediately (within 1 week) after baseline pre-training evaluation is completed.	Delayed n=3 Participants 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
Assessment of Living With Aphasia (ALA, Kagan et al., 2010) Immediately after Training	2.67 units on a scale Standard Deviation 0.67	2.33 units on a scale Standard Deviation 0.06
Assessment of Living With Aphasia (ALA, Kagan et al., 2010) Three months after training	2.68 units on a scale Standard Deviation 0.69	2.43 units on a scale Standard Deviation 0.23

PRIMARY outcome

Timeframe: Once within approximately 1 week of the end of training, then once approximately 3 months after end of training

Participants were score on a PI-adapted version of the Pet Partners Animal-Handler Evaluation. Each participant was scored on a 3-point scale ( 0= not ready (minimum), 1= ok, 2= best (maximum)) by a certified professional dog trainer on their cueing of each of five basic obedience behaviors (LOOK, TOUCH TARGET, SIT, STAY, COME), hence the maximum score on each summative evaluation is 10 (rating of 2 x each of the 5 obedience behaviors). On this scale, a higher number indicates a better outcome. An a-priori criterion was set at 5 (out of 10) or higher for achieving competence.

Outcome measures

Outcome measures
Measure	Immediate n=9 Participants Participants in this group will begin the training protocol immediately (within 1 week) after baseline pre-training evaluation is completed.	Delayed n=3 Participants 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
PI-adapted Version of Pet Partners Animal-handler Evaluation. Immediately after training	8.8 units on a scale Standard Deviation 1.2	5.3 units on a scale Standard Deviation 5.0
PI-adapted Version of Pet Partners Animal-handler Evaluation. Three months after training	9.2 units on a scale Standard Deviation 1.1	8 units on a scale Standard Deviation 3.5

SECONDARY outcome

Timeframe: Once within approximately 1 week of the end of training, then once approximately 3 months after end of training

The Confidence after Stroke Measures is a self-report measure that assesses three aspects of confidence after stroke, self-confidence, positive attitude, and social confidence. Per Horne et al., (2017) Participants self-rate on scales, with total values 0-81: Scale One -Self - Confidence = 0-27 Scale Two -Positive Attitude =0-24 Scale Three -Social Confidence =0-30 Higher scores are associated with higher levels of confidence. A change on total score of 4 or more is reported as being considered clinically significant. A score of 36 (-1 SD) indicates a possible concern, a score of 28(-2 SD) indicates a probable problem.

Outcome measures

Outcome measures
Measure	Immediate n=9 Participants Participants in this group will begin the training protocol immediately (within 1 week) after baseline pre-training evaluation is completed.	Delayed n=3 Participants 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
The Confidence After Stroke Measure (Horne et al., 2017) Immediately after training	47.7 units on a scale Standard Deviation 9.7	55.67 units on a scale Standard Deviation 7.6
The Confidence After Stroke Measure (Horne et al., 2017) Three months after training	49.4 units on a scale Standard Deviation 13.9	51.3 units on a scale Standard Deviation 7.4

SECONDARY outcome

Timeframe: Once within approximately 1 week of the end of training, then once approximately 3 months after end of training

The Behavioral Assessment of Dysexecutive Syndrome is a standardized assessment of executive function that evaluates skills including planning, organization, and problem-solving. Total profile scores range between 0 (min) - 24 (max), higher scores are associated with a better outcome, i.e., more accurate performance. Total profile scores comprise sub-scores from six subtests: Temporal judgement - ability to estimate how long to complete various activities of daily life events. Rule shift cards - ability to change an established pattern of responding Action program - practical problem solving. Key search - strategy formation. Zoo map - planning. Modified six elements - planning, task scheduling and performance monitoring. Complete details are available in the BADS manual. This measure was used for exploratory purposes. It has not been validated for use with individuals with aphasia and performance may be confounded by language difficulties associated with aphasia.

Outcome measures

Outcome measures
Measure	Immediate n=9 Participants Participants in this group will begin the training protocol immediately (within 1 week) after baseline pre-training evaluation is completed.	Delayed n=3 Participants 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
Behavioural Assessment of Dysexecutive Syndrome (BADS) (Wilson et al., 1996) Immediately after training	14.22 units on a scale Standard Deviation 5.56	16.7 units on a scale Standard Deviation 3.5
Behavioural Assessment of Dysexecutive Syndrome (BADS) (Wilson et al., 1996) Three months after training	15.3 units on a scale Standard Deviation 4.0	17.3 units on a scale Standard Deviation 3.8

Adverse Events

Immediate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Delayed

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sharon Antonucci, Ph.D CCC-SLP, C-AAIS

Jefferson Moss Rehabilitation Research Institute

Phone: 215-663-6561

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place