Pet Partners for Promotion of Academic Life Skills

Anxiety Disorders and Symptoms Clinical Trial

— Pet PALS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03530943
• Other study ID #: 126634-001
• Status: Recruiting
• Phase: N/A
• Start date: August 2016
• Est. completion date: December 2018

Study information

• Verified date: May 2018
• Source: Washington State University
• Contact: Patricia Pendry, PhD
• Phone: 509-335-8365
• Email: ppendry[@]wsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Alpha-amylase
• Animal Behavior
• Animal Stress
• Anxiety Disorders
• Anxiety Disorders and Symptoms
• Cortisol
• Depression Disorders and Symptoms
• Disease
• Dyadic Interaction
• Executive Functioning
• Momentary Emotion
• Motivation and Learning
• Perceived Stress
• Stress Prevention
• Study Strategies

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Washington State University	Pullman	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Washington State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Video observation coding	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.
Primary	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).
Primary	Change in Salivary Cortisol (Basal)		Salivary cortisol was measured immediately preceding the beginning of each of the four programming sessions
Primary	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.
Primary	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
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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	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)
Secondary	Salivary Alpha-Amylase (Basal)		Salivary alpha-amylase was measured immediately preceding the beginning of each of the four programming sessions
Secondary	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.
Secondary	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)
Secondary	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).