Anxiety Disorders and Symptoms Clinical Trial
— Pet PALSOfficial title:
Efficacy of College-Based, Animal-Assisted Stress-Prevention Programs on Human and Animal Participants
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Washington State University | Pullman | Washington |
Lead Sponsor | Collaborator |
---|---|
Washington State University |
United States,
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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