Efficacy Study of an Animal-assisted Intervention in Adolescents Admitted to Acute Psychiatric Units: Mentaldog Multicenter Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 178
- 试验地点
- 6
- 主要终点
- Change from baseline General Self-Efficacy Scale (GSE) at 2 weeks.
研究概览
简要总结
The purpose of the present study was to evaluate the efficacy of AAT intervention in adolescents admitted to the Acute Child and Adolescent Psychiatry Unit, regardless of diagnosis, in terms of improving self-efficacy and reducing anxiety symptoms. To assess professional opinions on the effects of intervention on participants, and to determine participant satisfaction. These objectives were accomplished through a multicenter, non-randomized, open-label, two-arm controlled study of AAT for adolescents with mental disorders.
详细描述
The rationale of this study was to evaluate the efficacy of Animal Assisted Therapy (with therapy dogs) in adolescents admitted to the Acute Child and Adolescent Psychiatry Unit and regardless of diagnosis. The investigators conducted a multicenter, non-randomized, controlled, open-label, two-arm clinical trial in three hospitals. A total of 178 adolescents admitted to the Acute Child and Adolescent Psychiatry Unit were included in the study. Participants from the three hospitals were assigned to Experimental Group (n=114) and participants from one hospital were assigned to Control Group (n=64). Both the experimental group and the control group carried out a total of two one-hour group sessions at the hospitals' own facilities, on a weekly basis for two consecutive weeks; with the additional assistance of the therapy dog in the Experimental group. The investigators evaluated changes on self-efficacy and anxiety symptoms at pre-treatment and post-treatment; and they assessed professional opinions on the effects of intervention on participants at post-treatment, and determined participant satisfaction at post-treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be between 13 and 17 years of age.
- •Willing to participate in the study on a voluntary basis.
- •Delivery of the information sheet and signature of the informed consent (participant and legal guardian).
- •Attendance at both group sessions from the intervention.
排除标准
- •If in the initial interview they declared having allergy or fear of dogs.
- •History of aggression towards animals.
- •Re-admissions who had already participated in the study.
- •If, when informed, the patient and/or his/her legal guardian did not wish to participate in the study.
结局指标
主要结局
Change from baseline General Self-Efficacy Scale (GSE) at 2 weeks.
时间窗: This scale was administered at baseline and at week 2
Is a generic self-administered instrument for measuring self-efficacy beliefs in certain life situations. The total scale score ranges from 10 to 40 points.
Change from baseline State-Trait Anxiety Inventory Questionnaire (STAI) at 2 weeks.
时间窗: This questionnaire was administered at baseline and at week 2
Is a self-administered questionnaire that assesses the levels of clinical anxiety (both trait anxiety ("most of the time") and state anxiety ("at the present moment")). The total score on each of the subscales ranges from 0 to 60 points.
次要结局
- Participant evaluation questionnaire for professionals.(At the end of the intervention (week 2).)