Dog Assisted Therapy Program for Children With Attention Deficit Hyperactivity Disorder: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Change from baseline Children's Global Assessment Scale (CGAS) at 14 weeks.
研究概览
简要总结
The purpose of this study was to evaluate the efficacy of AAT intervention in children with Attention Deficit Hyperactivity Disorder (ADHD), in terms of improving functionality, ADHD-associated symptoms, attention and working memory. Participants were recruited from a community Child and Adolescent Mental Health Service and a Primary Health Care Center. These objectives were accomplished through a multicenter, randomized clinical trial, open-label, two-arm study of AAT for children with ADHD.
详细描述
The purpose of the present study was to evaluate the efficacy of Animal Assisted Therapy (with therapy dogs) in in children with Attention Deficit Hyperactivity Disorder (ADHD). The investigators conducted a multicenter, randomized, controlled, open-label, two-arm clinical trial. Thirty-six children aged 7-12 diagnosed with ADHD were randomized in two groups. Experimental group: 14 animal assisted therapy (AAT) psychoeducational sessions (once-a-week, 60 minutes) + treatment as usual and control group: treatment as usual. Participants were recruited from a community Child and Adolescent Mental Health Service and a Primary Health Care Center. The investigators evaluated changes on functionality, ADHD-associated symptoms, attention and working memory at pre-treatment and post-treatment. Assessment included intelligence test, ADHD symptoms referred by parents and teacher's (Conners Rating Scale), attention measures (Conners Continuous Performance Test (CPT-3) and children's functioning (Children's Global Assessment Scale (CGAS)).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 7 and 12 years old (included).
- •Diagnosis of ADHD confirmed at the Child and Adolescent Mental Health Service.
- •Intelligence quotient of 80 or higher.
- •Delivery of the information sheet and signature of the informed consent.
排除标准
- •If in the initial interview they declared having allergy or fear of dogs.
- •History of aggression towards animals.
- •Co-morbidity with other disorders (conduct disorders, autism spectrum disorders, anxiety disorder or depression).
- •If the treatment regimen was modified during the intervention period.
结局指标
主要结局
Change from baseline Children's Global Assessment Scale (CGAS) at 14 weeks.
时间窗: This scale was administered at baseline and at week 14
It is a numerical scale to rate the overall functioning of young people under 18 years of age. Scores range from 1 to 100. A higher score indicates better functioning.
Change from baseline Clinical Global Impression - Severity Scale (CGI-S) at 14 weeks
时间窗: This scale was administered at baseline and at week 14
Is an instrument for measuring symptom severity of patients with mental disorders. Uses a single item on a Likert scale of seven values from 1= "Normal, not at all ill" to 7= "Among the most extremely ill patients".
次要结局
- Change from baseline Wechsler Intelligence Scale for Children (WISC-IV) at 14 weeks.(This scale was administered at baseline and at week 14)
- Change from baseline Conners' Continuous Performance Test 3rd Edition (Conners CPT 3) at 14 weks(This test was administered at baseline and at week 14)