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临床试验/NCT07717190
NCT07717190进行中(未招募)不适用

Long-term Sustainability of the Effects of Dog-Assisted Therapy in Children and Adolescents With Fetal Alcohol Spectrum Disorder: a 12-month Longitudinal Study

Hospital Universitari Vall d'Hebron Research Institute1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2025年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
55
试验地点
1
主要终点
Wechsler Intelligence Scale for Children

研究概览

简要总结

This study looks at whether dog-assisted therapy helps children and adolescents with fetal alcohol spectrum disorder improve social skills, behavior, quality of life, and emotional well-being, and whether these benefits last over time. It is also aimed at assessing caregivers' emotional well-being. Participants will already have completed the therapy, and the study will follow them at different time points to see if the changes remain months later. Families and health care providers should know that the evaluation uses standard questionnaires and clinical ratings, with no new invasive procedures, and the main goal is to better understand which children and families benefit most and how to make this type of therapy more effective in routine care.

详细描述

This longitudinal study evaluates whether the benefits of dog-assisted therapy in children and adolescents with fetal alcohol spectrum disorder are maintained over time. The project focuses on social functioning, behavior, quality of life, clinical severity, and the emotional well-being of caregivers, using repeated follow-up assessments after treatment. The aim is to determine the durability of the intervention effects and identify factors that may influence long-term outcomes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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.

研究组 & 干预措施

Long-term Follow-up of Dog-Assisted Therapy.

Other

This arm includes children and adolescents with fetal alcohol spectrum disorder who have previously completed a structured dog-assisted therapy program. Participants are followed at later time points to assess whether improvements in social skills, behavior, quality of life, and caregiver emotional well-being are maintained over time.

干预措施: Dog assisted therapy (Behavioral)

结局指标

主要结局

Wechsler Intelligence Scale for Children

时间窗: Single administration baseline

Intellectual Quotient

Child Behavior Checklist (CBCL by Achenbach)

时间窗: 3, 6 and 12 months after baseline

Internalizing/ Externalizing Symptoms maximum scores for symptom severity

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

时间窗: 3, 6 and 12 months after baseline

Social skills assessment - 0 to 60 max scotring

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

时间窗: 3, 6 and 12 months after baseline

Quality of life assesment

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

时间窗: 3,6 and 12 months after baseline

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 (1)

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