Stress PreventionPet PALSNCT03530943
Pet Partners for Promotion of Academic Life Skills
A study testing Animal Assisted Activities and Academic Stress Management tools in people with Stress Prevention and Cortisol, run by Washington State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Prevention, Cortisol, Anxiety Disorders and Symptoms
- What is being tested?
- Animal Assisted Activities and Academic Stress Management tools
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Current enrollment at the campus
Who cannot join
- Children under 18 years old
- Prior history of animal abuse
- Participation in an an academic stress management workshop within 6 months of study participation
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Washington State University
Pullman, Washington, 99164
Patricia Pendry, PhD, 509-335-8365, ppendry@wsu.edu
About this study
Official title: 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.
- Conditions
- Stress Prevention, Cortisol, Anxiety Disorders and Symptoms, Depression Disorders and Symptoms, Executive Functioning, Motivation and Learning
- Being tested
- Animal Assisted Activities, Academic Stress Management tools
- Medical subject headings
- Anxiety Disorders, Behavior, Animal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal Assisted ActivitiesBehavioural
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
Academic Stress Management toolsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Academic Stress Management | Active comparator | 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. Receives: Behavioral: Academic Stress Management tools |
| Human Animal Interaction Enhanced | Experimental | 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. Receives: Behavioral: Animal Assisted Activities; Behavioral: Academic Stress Management tools |
| Human Animal Interaction only | Experimental | 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. Receives: Behavioral: Animal Assisted Activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Salivary Cortisol (Diurnal)
Participants provided three samples (wakeup, afternoon, bedtime) over two consecutive days for a total of six samples.
Measured: 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)
Measured: Salivary cortisol was measured immediately preceding the beginning of each of the four programming sessions
Change in Salivary Cortisol (Momentary Reactivity)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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 outcomes (5)
Salivary Alpha-Amylase (Diurnal)
Participants provided three samples (wakeup, afternoon, bedtime) over two consecutive days for a total of six samples.
Measured: 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)
Measured: Salivary alpha-amylase was measured immediately preceding the beginning of each of the four programming sessions
Salivary Alpha-Amylase (Momentary Reactivity)
Measured: 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
Measured: 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)
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study startAug 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia Pendry, PhD, Principal investigator, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530943
- Sponsor's protocol ID
- 126634-001
- Acronym
- Pet PALS
- Status last verified
- May 2018
- First submitted
- 20 Mar 2018
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32183453Pendry 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.
PubMed 31509993
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of College-Based, Animal-Assisted Stress-Prevention Programs on Human and Animal Participants
- ClinicalTrials.gov ID
- NCT03530943
- Acronym / sponsor ID
- Pet PALS / 126634-001
- Conditions
- Stress Prevention, Cortisol, Anxiety Disorders and Symptoms, Depression Disorders and Symptoms, Executive Functioning, Motivation and Learning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 21 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Academic Stress Management | Active comparator | Behavioral: Academic Stress Management toolsStudents 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. |
| Human Animal Interaction Enhanced | Experimental | Behavioral: Animal Assisted Activities, Behavioral: Academic Stress Management toolsStudents 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. |
| Human Animal Interaction only | Experimental | Behavioral: Animal Assisted ActivitiesStudents 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Current enrollment at the campus
Key exclusion criteria (3 listed)
- Children under 18 years old
- Prior history of animal abuse
- Participation in an an academic stress management workshop within 6 months of study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animal Assisted ActivitiesStudents 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 | Behavioural | Human Animal Interaction Enhanced, Human Animal Interaction only |
| Academic Stress Management toolsEvidence-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 | Behavioural | Academic Stress Management, Human Animal Interaction Enhanced |
Primary outcome
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.
Change in Salivary Cortisol (Basal)
Time frame: 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.
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
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).
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).
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).
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.
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).
5 secondary outcomes
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)
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 (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.
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)
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
- Derived from this study: PubMed 32183453Pendry 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.
- Derived from this study: PubMed 31509993Pendry 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Pendry, PhD principal investigator
Washington State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animal Assisted Activities and Academic Stress Management tools in people with Stress Prevention and Cortisol, run by Washington State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia Pendry, PhD (509-335-8365, ppendry@wsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03530943, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2018.