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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03530943
Other study ID # 126634-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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).
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