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Clinical Trials/NCT03530943
NCT03530943UnknownNot Applicable

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

Washington State University1 site in 1 country300 target enrollmentStarted: August 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
300
Locations
1
Primary Endpoint
Change in Depression (Beck Depression Inventory)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Masking Description

Participants remained unaware of their treatment allocation until after completing the baseline (pretest) assessments and the onset of their intervention

Eligibility Criteria

Ages
18 Years to 30 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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.

Intervention: Academic Stress Management tools (Behavioral)

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.

Intervention: Animal Assisted Activities (Behavioral)

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.

Intervention: Academic Stress Management tools (Behavioral)

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.

Intervention: Animal Assisted Activities (Behavioral)

Outcomes

Primary Outcomes

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 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).

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 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.

Secondary Outcomes

  • Salivary Alpha-Amylase (Diurnal)(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))
  • 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).)
  • 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))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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