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临床试验/NCT06763614
NCT06763614已完成不适用

A Randomised Controlled Study of Dog Assisted Therapy: Comparing a Short and a Long Version Program for Patients with Fetal Alcohol Spectrum Disorder.

Hospital Universitari Vall d'Hebron Research Institute2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2022年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
2
主要终点
Wechsler Intelligence Scale for Children

研究概览

简要总结

The objective of the present study was to assess the efficacy of a shorter version program of Dog Assisted Therapy (DAT) (8 sessions) compared to a longer version (16 sessions) for children and adolescents with Fetal Alcohol Syndrome (FASD). We evaluated the impact of DAT on social skills, internalizing and externalizing problems, quality of life, severity of the disorder and emotional well-being of parents. We conducted a randomized controlled trial in a cohort of 55 patients with FASD.

详细描述

FASD can be classified into three subtypes. FAS is identified by (1) facial abnormalities, (2) growth deficits, abnormal brain development, or irregularities in neurophysiology, and (3) neurobehavioral issues. Partial Fetal Alcohol Spectrum Disorder (FASD) shares similarities but presents with fewer physical characteristics, while Alcohol-Related Neurobehavioral Disorder (ARND) solely exhibits neurobehavioral symptoms without facial anomalies.

Previous research has highlighted the effectiveness of psychological intervention programs focused on emotional regulation for individuals with FASD. Similarly, studies have emphasized the benefits of interventions targeting social skills. These interventions have been shown to result in reductions in externalizing behaviors, with social skills training specifically correlating with improvements in social competence and a decrease in problematic behaviors Recently a new form of behavioral therapy has been gaining popularity in improving the physical and mental health of young adults, known as Animal Assisted Therapy (AAT). Animal Assisted Therapy lays its foundation in human attachment theory and social cognitive theory where it is argued that animals can be potentially viewed as a transitional attachment object and thus aid to improve psychosocial functioning.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • all participants needed to have stable doses of medication for at least two months before the study and agree not to seek out any other psychiatric or psychological treatment during the study.

排除标准

  • Patients who were not behaviorally stable, presented agressive behavior or required more intensive treatment (hospitalization or day hospital) were excluded.

结局指标

主要结局

Wechsler Intelligence Scale for Children

时间窗: Once- Pre intervention week 1 - Post intervention in week 16

Intellectual Quotient

Child Behavior Checklist (CBCL by Achenbach)

时间窗: Once- Pre intervention week 1 - Post intervention in week 16

Internalizing/ Externalizing Symptoms maximum scores for symptom severity 113

Social Skills Improvement System-Parent Form (SSIS-P)

时间窗: Once- Pre intervention week 1 - Post intervention in week 16

Social skills assessment - 0 to 60 max scotring

KidScreen 27- 0 maximum 135 - highest severity symptoms at 135

时间窗: Once- Pre intervention week 1 - Post intervention in week 16

Quality of life assesment

Clinical Global Impression Scale for Severity.0 to 7 (7 most severely ill).

时间窗: Once- Pre intervention week 1 - Post intervention in week 16

Severity of FASD symptoms

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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