Recruiting

Observational Study

Sponsor:

Washington State University

Code:

NCT03530943

Conditions

Stress Prevention

Cortisol

Anxiety Disorders and Symptoms

Depression Disorders and Symptoms

Executive Functioning

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Accepted

Interventions

Animal Assisted Activities

Academic Stress Management tools

Study Details

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.

Conditions

Stress Prevention

Cortisol

Anxiety Disorders and Symptoms

Depression Disorders and Symptoms

Executive Functioning

Study ID

NCT03530943

Start date

Aug, 2016

Status verified date

May, 2018

Completion date

Dec, 2018

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

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

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). ]
  • 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). ]
  • 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). ]

Central Contacts and Locations

Central contacts

Patricia Pendry, PhD

509-335-8365ppendry@wsu.edu

Locations

Washington State University

Recruiting

Pullman, Washington, United States, 99164

Contacts

Patricia Pendry, PhD

509-335-8365ppendry@wsu.edu

More Information

Sponsor

Washington State University

Last update posted

May 21, 2018

Last verified

May, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Washington State University on 2018-05-21.