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

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ClinicalTrials.gov Identifier: NCT04610346
Recruitment Status : Active, not recruiting
First Posted : October 30, 2020
Last Update Posted : May 21, 2024
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Sharon Antonucci, PhD, Albert Einstein Healthcare Network

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.

Condition or disease Intervention/treatment Phase
Aphasia Behavioral: Persons with Aphasia Training Dogs Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to one of two study arms, immediate or delayed treatment.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessing an Animal-Assisted Treatment Program for Adults With Aphasia: The Persons With Aphasia Training Dogs Program
Actual Study Start Date : March 30, 2023
Estimated Primary Completion Date : August 28, 2024
Estimated Study Completion Date : August 28, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arm Intervention/treatment
Immediate
Participants in this group will begin the training protocol immediately (within 1 week) after baseline pre-training evaluation is completed.
Behavioral: Persons with Aphasia Training Dogs Program
Participants will learn and apply positive reinforcement training techniques for working with dogs to train them in basic obedience behaviors (e.g., SIT, STAY).
Other Name: PATD Program

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
Behavioral: Persons with Aphasia Training Dogs Program
Participants will learn and apply positive reinforcement training techniques for working with dogs to train them in basic obedience behaviors (e.g., SIT, STAY).
Other Name: PATD Program




Primary Outcome Measures :
  1. Change on Assessment of Living with Aphasia (ALA, Kagan et al., 2010) [ Time Frame: 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 ]
    The ALA is a pictographic self-report measure of quality of life developed to assess the impact of aphasia on daily life

  2. Change on PI-adapted version of Pet Partners Animal-handler Evaluation. [ Time Frame: One observation/week during each of the 6 (once weekly) training sessions, one within 1 week of ending training, one 3 month follow-up ]
    This is observational measure. Participants are assigned scores by an evaluator related to their use of positive reinforcement dog training techniques. Scores range on a scale of 0 ("not ready") to 2 ("best").


Secondary Outcome Measures :
  1. Change on The Confidence after Stroke Measure (Horne et al., 2017) [ Time Frame: 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 ]
    Self report survey that uses likert scale response options

  2. Change on Behavioural Assessment of Dysexecutive Syndrome (Wilson et al., 1996) [ Time Frame: 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 ]
    A behavioral assessment of cognitive skills including planning, organization, problem solving and attention.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04610346


Locations
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United States, Pennsylvania
Moss Rehabilitation Research Institute
Elkins Park, Pennsylvania, United States, 19027
Sponsors and Collaborators
Albert Einstein Healthcare Network
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Sharon M Antonucci, Ph.D. AEHN
Publications:
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Responsible Party: Sharon Antonucci, PhD, Director, MossRehab Aphasia Center, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT04610346    
Other Study ID Numbers: IRB-2020-450
R03HD101146 ( U.S. NIH Grant/Contract )
First Posted: October 30, 2020    Key Record Dates
Last Update Posted: May 21, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sharon Antonucci, PhD, Albert Einstein Healthcare Network:
aphasia
animal-assisted therapy
Additional relevant MeSH terms:
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Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases