Clinical trial NCT03530943: Pet Partners for Promotion of Academic Life Skills
Official title: Efficacy of College-Based, Animal-Assisted Stress-Prevention Programs on Human and Animal Participants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Washington State University
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change in Salivary Cortisol (Diurnal)
timeFrame: 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).
measure: Change in Salivary Cortisol (Basal)
timeFrame: Salivary cortisol was measured immediately preceding the beginning of each of the four programming sessions
measure: Change in Salivary Cortisol (Momentary Reactivity)
timeFrame: Salivary cortisol was measured two to three times each of the four programming sessions in response to various program activities.
measure: Change in Momentary Emotion (Experience Sampling Method Questionnaire)
timeFrame: 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
measure: Change in Learning and Study Strategies (Learning and Study Strategies Inventory)
timeFrame: 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).
measure: Change in Depression (Beck Depression Inventory)
timeFrame: 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).
measure: Change in Anxiety (Beck Anxiety Inventory)
timeFrame: 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).
measure: Change in Perceived Stress (Perceived Stress Scale - 10)
timeFrame: 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).
measure: Change in Executive Functioning (Behavior Rating Inventory of Executive Functioning - Adult Version)
timeFrame: 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:
measure: Salivary Alpha-Amylase (Diurnal)
timeFrame: 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)
measure: Salivary Alpha-Amylase (Basal)
timeFrame: Salivary alpha-amylase was measured immediately preceding the beginning of each of the four programming sessions
measure: Salivary Alpha-Amylase (Momentary Reactivity)
timeFrame: Salivary alpha-amylase was measured two to three times during each of the four programming sessions in response to various program activities.
measure: Attitudes Towards Learning
timeFrame: 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)
measure: Self-perceived worry (Penn State Worry Questionnaire)
timeFrame: 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 outcomes:
measure: Video observation coding
timeFrame: 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.
Locations:
city: Pullman
country: United States
facility: Washington State University
state: Washington
Study officials:
affiliation: Washington State University
name: Patricia Pendry, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.