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

Primary Purpose

Stress Prevention, Cortisol, Anxiety Disorders and Symptoms

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Animal Assisted Activities
Academic Stress Management tools
Sponsored by
Washington State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress Prevention

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Washington State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Academic Stress Management

Human Animal Interaction Enhanced

Human Animal Interaction only

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in Salivary Cortisol (Diurnal)
Participants provided three samples (wakeup, afternoon, bedtime) over two consecutive days for a total of six samples.
Change in Salivary Cortisol (Basal)
Change in Salivary Cortisol (Momentary Reactivity)
Change in Momentary Emotion (Experience Sampling Method Questionnaire)
Change in Learning and Study Strategies (Learning and Study Strategies Inventory)
Change in Depression (Beck Depression Inventory)
Change in Anxiety (Beck Anxiety Inventory)
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.
Change in Executive Functioning (Behavior Rating Inventory of Executive Functioning - Adult Version)

Secondary Outcome Measures

Salivary Alpha-Amylase (Diurnal)
Participants provided three samples (wakeup, afternoon, bedtime) over two consecutive days for a total of six samples.
Salivary Alpha-Amylase (Basal)
Salivary Alpha-Amylase (Momentary Reactivity)
Attitudes Towards Learning
Self-perceived worry (Penn State Worry Questionnaire)

Full Information

First Posted
March 20, 2018
Last Updated
May 8, 2018
Sponsor
Washington State University
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1. Study Identification

Unique Protocol Identification Number
NCT03530943
Brief Title
Pet Partners for Promotion of Academic Life Skills
Acronym
Pet PALS
Official Title
Efficacy of College-Based, Animal-Assisted Stress-Prevention Programs on Human and Animal Participants
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Prevention, Cortisol, Anxiety Disorders and Symptoms, Depression Disorders and Symptoms, Executive Functioning, Motivation and Learning, Momentary Emotion, Study Strategies, Perceived Stress, Animal Behavior, Animal Stress, Dyadic Interaction, Alpha-amylase

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants remained unaware of their treatment allocation until after completing the baseline (pretest) assessments and the onset of their intervention
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Academic Stress Management
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Human Animal Interaction Enhanced
Arm Type
Experimental
Arm Description
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.
Arm Title
Human Animal Interaction only
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Animal Assisted Activities
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Academic Stress Management tools
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Salivary Cortisol (Diurnal)
Description
Participants provided three samples (wakeup, afternoon, bedtime) over two consecutive days for a total of six samples.
Time Frame
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).
Title
Change in Salivary Cortisol (Basal)
Time Frame
Salivary cortisol was measured immediately preceding the beginning of each of the four programming sessions
Title
Change in Salivary Cortisol (Momentary Reactivity)
Time Frame
Salivary cortisol was measured two to three times each of the four programming sessions in response to various program activities.
Title
Change in Momentary Emotion (Experience Sampling Method Questionnaire)
Time Frame
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
Title
Change in Learning and Study Strategies (Learning and Study Strategies Inventory)
Time Frame
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).
Title
Change in Depression (Beck Depression Inventory)
Time Frame
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).
Title
Change in Anxiety (Beck Anxiety Inventory)
Time Frame
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).
Title
Change in Perceived Stress (Perceived Stress Scale - 10)
Description
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.
Time Frame
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).
Title
Change in Executive Functioning (Behavior Rating Inventory of Executive Functioning - Adult Version)
Time Frame
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 Measure Information:
Title
Salivary Alpha-Amylase (Diurnal)
Description
Participants provided three samples (wakeup, afternoon, bedtime) over two consecutive days for a total of six samples.
Time Frame
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)
Title
Salivary Alpha-Amylase (Basal)
Time Frame
Salivary alpha-amylase was measured immediately preceding the beginning of each of the four programming sessions
Title
Salivary Alpha-Amylase (Momentary Reactivity)
Time Frame
Salivary alpha-amylase was measured two to three times during each of the four programming sessions in response to various program activities.
Title
Attitudes Towards Learning
Time Frame
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)
Title
Self-perceived worry (Penn State Worry Questionnaire)
Time Frame
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 Pre-specified Outcome Measures:
Title
Video observation coding
Description
Video recordings capturing student, dog, and handler behaviors during the human-animal interaction sessions
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Pendry, PhD
Phone
509-335-8365
Email
ppendry@wsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Pendry, PhD
Organizational Affiliation
Washington State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington State University
City
Pullman
State/Province
Washington
ZIP/Postal Code
99164
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Pendry, PhD
Phone
509-335-8365
Email
ppendry@wsu.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32183453
Citation
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.
Results Reference
derived
PubMed Identifier
31509993
Citation
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.
Results Reference
derived

Learn more about this trial

Pet Partners for Promotion of Academic Life Skills

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