Pet Partners for Promotion of Academic Life Skills

Study Overview
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Brief Summary
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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.

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

Conditions
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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

Intervention / Treatment
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* Behavioral: Animal Assisted Activities
* Behavioral: Academic Stress Management tools


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Academic Stress Management<br>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<br>* 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<br>|
| Experimental: Human Animal Interaction Enhanced<br>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: Animal Assisted Activities<br>* 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<br>Behavioral: Academic Stress Management tools<br>* 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<br>|
| Experimental: Human Animal Interaction only<br>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<br>* 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<br>|

What is the study measuring?
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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). |