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

May 8, 2018 updated by: Washington State University

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Patricia Pendry, PhD
  • Phone Number: 509-335-8365
  • Email: ppendry@wsu.edu

Study Locations

  • United States
    • Washington
      • Pullman, Washington, United States, 99164
        • Recruiting
        • Washington State University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Salivary Cortisol (Diurnal)
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).
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)
Time Frame: Salivary cortisol was measured immediately preceding the beginning of each of the four programming sessions
Salivary cortisol was measured immediately preceding the beginning of each of the four programming sessions
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.
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)
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
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)
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).
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)
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).
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)
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).
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)
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).
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)
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).
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Salivary Alpha-Amylase (Diurnal)
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)
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)
Time Frame: Salivary alpha-amylase was measured immediately preceding the beginning of each of the four programming sessions
Salivary alpha-amylase was measured immediately preceding the beginning of each of the four programming sessions
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.
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
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)
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)
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).
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Video observation coding
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.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Patricia Pendry, PhD, Washington State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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