Pet Partners for Promotion of Academic Life Skills (Pet PALS)

Efficacy of College-Based, Animal-Assisted Stress-Prevention Programs on Human and Animal Participants

The current study utilized a randomized controlled trial, conducted in a real-life setting, to determine whether, how, under which conditions, and for whom, infusing various levels of human-animal interaction (HAI) in a 4-week, university-based stress prevention program provides an effective approach to prevent negative ramifications of university students stress, promote student executive functioning and learning, while safeguarding animal welfare. This study will examine effects of sole exposure to evidence-based stress prevention content, hands-on HAI with registered PET Partner teams, or combinations thereof on students' moment-to-moment well-being and longer-term functioning in socioemotional, cognitive and physiological domains.This study will also develop a comprehensive coding system and measure the dynamic nature of behavior of participants, handlers and animals during university- based animal assisted activities, as well as the HAI environment. The data and analyses will then be utilized to inform the development of a quantitative measure to capture of the quality of human animal interaction in various settings to experimentally determine causal pathways underlying program effects on humans and animals.

Study Overview

• Status: Unknown
• Conditions: Anxiety Disorders and Symptoms; Cortisol; Perceived Stress; Executive Functioning; Stress Prevention; Depression Disorders and Symptoms; Motivation and Learning; Momentary Emotion; Study Strategies; Animal Behavior; Animal Stress; Dyadic Interaction; Alpha-amylase
• Intervention / Treatment: Behavioral: Academic Stress Management tools; Behavioral: Animal Assisted Activities

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Pullman, Washington, United States, 99164
      • Recruiting
      • Washington State University
      • Contact: Patricia Pendry, PhD; Phone Number: 509-335-8365; Email: ppendry@wsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Current enrollment at the campus

Exclusion Criteria:

• Children under 18 years old
• Prior history of animal abuse
• Participation in an an academic stress management workshop within 6 months of study participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Academic Stress Management; Students assigned to the Academic Stress Management (ASM) condition will attend a series of once weekly, one hour long workshops over four consecutive weeks during which time they will receive 100% exposure to various evidence-based academic stress management tools.	Behavioral: Academic Stress Management tools; Evidence-based workshops focus on evidence-based content and activities designed to enhance academic stress management knowledge and skills, motivation and learning, adaptive sleep, and study and test-taking behavior through strengthening physiological, emotion and behavioral regulation
Experimental: Human Animal Interaction Enhanced; Students assigned to the Human Animal Interaction - Enhanced (HAI-E) condition will attend a series of once weekly, one hour long workshops over four consecutive weeks. This group receives 50% exposure to structured and unstructured animal assisted activities and 50% exposure to various evidence-based academic stress management tools.	Behavioral: Academic Stress Management tools; Evidence-based workshops focus on evidence-based content and activities designed to enhance academic stress management knowledge and skills, motivation and learning, adaptive sleep, and study and test-taking behavior through strengthening physiological, emotion and behavioral regulation; Behavioral: Animal Assisted Activities; Students interact with canines in small group settings under the supervision of their handlers during structured and semi-structured activities designed to strengthen physiological, emotion and behavioral regulation
Experimental: Human Animal Interaction only; Students assigned to the Human Animal Interaction - only (HAI-O) condition will attend a series of once weekly, one hour long workshops over four consecutive weeks. This group will be receive 100% exposure to structured and semi-structured animal assisted activities.	Behavioral: Animal Assisted Activities; Students interact with canines in small group settings under the supervision of their handlers during structured and semi-structured activities designed to strengthen physiological, emotion and behavioral regulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Salivary Cortisol (Diurnal)	Participants provided three samples (wakeup, afternoon, bedtime) over two consecutive days for a total of six samples.	Diurnal salivary cortisol was measured three times: at baseline one week before the intervention; at post-test one week following the conclusion of the intervention (baseline+5 weeks); and at follow-up six weeks after the posttest (baseline+11 weeks).
Change in Salivary Cortisol (Basal)		Salivary cortisol was measured immediately preceding the beginning of each of the four programming sessions
Change in Salivary Cortisol (Momentary Reactivity)		Salivary cortisol was measured two to three times each of the four programming sessions in response to various program activities.
Change in Momentary Emotion (Experience Sampling Method Questionnaire)		Momentary emotion was measured three times each of the four programming sessions, immediately before entering the program area, and two additional times 30 and 50 minutes after the program start following various 10 minute activities
Change in Learning and Study Strategies (Learning and Study Strategies Inventory)		Learning and study strategies were measured three times: at baseline one week before the intervention; at post-test one week following the conclusion of the intervention (baseline+5 weeks); at follow-up six weeks after the posttest (baseline+11 weeks).
Change in Depression (Beck Depression Inventory)		Depression was measured three times: at baseline one week before the intervention; at post-test one week following the conclusion of the intervention (baseline + 5 weeks); and at follow-up six weeks after the posttest (baseline + 11 weeks).
Change in Anxiety (Beck Anxiety Inventory)		Anxiety was measured three times: at baseline one week before the intervention; at post-test one week following the conclusion of the intervention (baseline + 5 weeks); and at follow-up six weeks after the posttest (baseline + 11 weeks).
Change in Perceived Stress (Perceived Stress Scale - 10)	The Perceived Stress Scale -10 is a 10-item measure resulting in a single composite score ranging from 0 to 40 with higher scores representing higher levels of reported perceived stress.	Perceived stress was measured three times: at baseline one week before the intervention; at post-test one week following the conclusion of the intervention (baseline + 5 weeks); and at follow-up six weeks after the posttest (baseline + 11 weeks).
Change in Executive Functioning (Behavior Rating Inventory of Executive Functioning - Adult Version)		Executive functioning was measured three times: at baseline one week before the intervention; at post-test one week following the conclusion of the intervention (baseline + 5 weeks); and at follow-up six weeks after the posttest (baseline + 11 weeks).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary Alpha-Amylase (Diurnal)	Participants provided three samples (wakeup, afternoon, bedtime) over two consecutive days for a total of six samples.	Diurnal salivary alpha-amylase was measured three times: at baseline one week before the intervention; at post-test one week following the conclusion of the intervention (baseline+5 weeks); and at followup six weeks after the posttest (baseline+11 weeks)
Salivary Alpha-Amylase (Basal)		Salivary alpha-amylase was measured immediately preceding the beginning of each of the four programming sessions
Salivary Alpha-Amylase (Momentary Reactivity)		Salivary alpha-amylase was measured two to three times during each of the four programming sessions in response to various program activities.
Attitudes Towards Learning		Attitudes towards learning were measured three times: at baseline one week before the intervention; at post-test one week following the conclusion of the intervention (baseline+5 weeks); and at follow-up six weeks after the posttest (baseline+11 weeks)
Self-perceived worry (Penn State Worry Questionnaire)		Self-perceived worry was measured three times: at baseline one week before the intervention; at post-test one week following the conclusion of the intervention (baseline + 5 weeks); and at follow-up six weeks after the posttest (baseline + 11 weeks).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Video observation coding	Video recordings capturing student, dog, and handler behaviors during the human-animal interaction sessions	Recordings captured each dog-handler station, capturing 70-80 minutes throughout the program beginning 10 minutes before participants entry in the room through the end of each session.

Collaborators and Investigators

• Sponsor: Washington State University
• Investigators: Principal Investigator: Patricia Pendry, PhD, Washington State University

Publications and helpful links

General Publications

• Pendry P, Carr AM, Gee NR, Vandagriff JL. Randomized Trial Examining Effects of Animal Assisted Intervention and Stress Related Symptoms on College Students' Learning and Study Skills. Int J Environ Res Public Health. 2020 Mar 15;17(6):1909. doi: 10.3390/ijerph17061909.
• Pendry P, Kuzara S, Gee NR. Evaluation of Undergraduate Students' Responsiveness to a 4-Week University-Based Animal-Assisted Stress Prevention Program. Int J Environ Res Public Health. 2019 Sep 10;16(18):3331. doi: 10.3390/ijerph16183331.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (Actual): May 21, 2018

Study Record Updates

• Last Update Posted (Actual): May 21, 2018
• Last Update Submitted That Met QC Criteria: May 8, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Anxiety Disorders
• Other Study ID Numbers: 126634-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No