A Pilot Study of the Effects of Interactions With Therapy Dogs on Child Stress Responsivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 2
- 主要终点
- Mean level and Change in Salivary cortisol
研究概览
简要总结
The objective of this study is to apply a rigorous experimental design to test whether children's interactions with therapy dogs increase immediate prosocial behavior and reduce immediate biological response to stress.
详细描述
The central goal of the study is to determine whether brief interactions with a therapy dog have an immediate impact on children's biological response to stress, prosocial behaviors, and self-reported mood in comparison to interactions with a stuffed toy dog. The study uses a randomized crossover design with two study arms; all children will receive the both interventions during the same session, with the timing of the intervention randomized across subject. All outcomes will be assessed during a single study visit. No follow-up data will be collected.
The study uses both between-group and within-subject comparisons. Between groups, the investigators predict that children who interact with a therapy dog prior to a psychosocial stress task (Arm 1) will show attenuated cortisol response to the stress task (primary outcome) and reduced physiological stress (secondary outcomes) compared to children who interact with a stuffed toy dog prior to the psychosocial stress task (Arm 2). As an additional control, children will also watch a 5 minute puppy video prior to the prosocial stress task and will then interact with a stuffed toy dog prior to the psychosocial stress task (Arm 3).
Conversely, children who interact with the therapy dog immediately prior to the in-lab behavior tasks (Arm 2) will show higher levels of behavioral carefulness and prosocial behavior (primary outcomes) compared to children who interact with the stuffed toy dog prior to the behavior tasks (Arm 1).
Within subjects across both study arms, increases in positive mood and decreases in negative mood (secondary outcomes) will be greatest following interaction with the therapy dog compared to the stuffed toy dog, after controlling for main effects of study arm. Within subjects, physiological markers of stress (secondary outcomes) will be lower during the interaction with the therapy dog than during interaction with the stuffed toy dog.
Investigators will seek additional funds to collect and analyze salivary oxytocin data. The hypothesis is that children will show greater increase in oxytocin following interaction with the therapy dog in comparison to interaction with the stuffed toy dog.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Participants will be unaware of which study arm they are assigned. Individuals performing the interventions will be blind to study condition. The investigator will be blind to study condition until data analysis. Video data will be coded by observers blind to the study condition. The primary outcomes assessor is not blind to study condition.
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children between the ages of 8-12 years old
排除标准
- •Limited comprehension of English
- •Severe neurological, medical, or psychiatric illnesses (e.g., schizophrenia, psychosis)
- •Severe asthma or animal allergies
- •Animal phobias
- •Use of medications that affect cortisol
结局指标
主要结局
Mean level and Change in Salivary cortisol
时间窗: Measured at baseline and over a 45 minute period before and after the psychosocial stress test
Salivary cortisol will be collected 7 times during the study visit.
Mean level Prosocial behavior assessed with the Zurich prosocial game
时间窗: Assessed after the 2nd intervention.
During the study visit prosocial behavior is assessed through total number of helping behaviors recorded during the Zurich prosocial game.
Mean level Behavioral carefulness assessed with the children's game, Operation
时间窗: Assessed after the 2nd intervention.
During the study visit, participants will play the game Operation. Behavioral carefulness metrics include number of errors and total time to complete the task.
次要结局
- Mean level and Change in Psychological Well Being assessed by the Positive and Negative Affect Scale for Children (PANAS-C)(Measured at the beginning of the study visit and before and after each intervention.)
- Mean level and Change in galvanic skin response measured with the E4 wristband(Assessed during both interventions and during the psychosocial stress test.)
- Mean level and Change in heart rate measured with the E4 wristband(Assessed during both interventions and during the psychosocial stress test.)