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Feasibility Study of UP-A-AST Parent Group for Adolescents With Autism and Co-occurring Anxiety/Depression

2026年6月9日 更新者：Karin Melin、Sahlgrenska University Hospital

Unified Protocol-Adolescent Autism Parent Group (UP-A-AST) for Adolescents With Autism Spectrum Disorder and Co-occurring Anxiety and/or Depressive Disorders: A Feasibility Study

Autism spectrum disorder (ASD) is associated with high rates of psychiatric comorbidity, particularly anxiety and depressive disorders, which contribute to significant impairment for affected youth and their families. Although cognitive behavioral therapy (CBT) is recommended as a first-line treatment for anxiety and depression in children and adolescents, there is a lack of evidence-based interventions specifically adapted for youth with ASD and co-occurring emotional disorders.

The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C/UP-A) is a CBT-based intervention targeting shared mechanisms underlying anxiety and depression. A parent-mediated adaptation, the Unified Protocol-Adolescent Autism Parent Group (UP-A-AST), has been developed to address the specific needs of adolescents with ASD and co-occurring anxiety and/or depressive disorders. Preliminary quality improvement work has shown promising results.

This study aims to evaluate the feasibility, acceptability, and preliminary effects of the UP-A-AST Parent Group in a child and adolescent outpatient psychiatric setting. The study will include parents of adolescents aged 12-17 years with ASD and co-occurring anxiety and/or depressive disorders. Outcomes include changes in adolescents' psychiatric symptoms and functional impairment, as well as parents' perceived parenting competence. Additionally, parents' experiences of participating in the intervention will be explored.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

72

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名：Sahlgrenska University Hospital
  • 电话号码：+46313421000

学习地点

  • 瑞典
      • Gothenburg、瑞典、41345
        • 招聘中
        • BUP- Specialmottagning, Sahlgrenska University Hospital
        • 接触：
          • Karin Melin, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Adolescents aged 12-17 years
  • Clinical diagnosis of autism spectrum disorder (ASD) according to DSM-IV, DSM-5, or ICD-10
  • Current diagnosis of anxiety disorder and/or depressive disorder according to DSM-5
  • Ongoing contact with a Child and Adolescent Psychiatry (BUP) outpatient clinic
  • Stable psychopharmacological treatment at the time of inclusion (if applicable)
  • Parents has participated in a psychoeducational program on autism within child and adolescent psychiatric services, or is assessed by the clinician to have equivalent knowledge

Exclusion Criteria:

  • Presence of a severe psychiatric disorder, such as psychotic disorder, bipolar disorder, or severe eating disorder
  • High suicide risk or suicide attempt within the past 12 months
  • Severe self-injurious behavior
  • Intellectual disability according to DSM-5
  • The adolescent is primarily in need of basic interventions for autism spectrum disorder
  • Parents are unable to attend all group sessions and/or lack the ability to engage in assigned home practice
  • Need for an interpreter

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：UP-A-AST Parent Group
Participants receive the Unified Protocol-Adolescent Autism Parent Group (UP-A-AST), a parent-mediated, group-based cognitive behavioral intervention adapted for adolescents with autism spectrum disorder and co-occurring anxiety and/or depressive disorders. The intervention is delivered to parents in a group format and focuses on enhancing understanding of emotional difficulties and providing strategies to support adolescents' emotion regulation and functioning
其他：Unified Protocol-Adolescent Autism Parent Group (UP-A-AST)
The intervention is delivered in a group format to parents and focuses on strengthening parenting skills and promoting the adolescent's mental health and functional outcomes.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change from baseline in RCADS Total Score through 3-Month Follow-up.
大体时间：Baseline, at completion of the intervention (10 weeks) and 3 months post intervention
Anxiety and depressive symptom severity will be assessed using the parent-reported version of the Revised Child Anxiety and Depression Scale (RCADS), a validated questionnaire measuring symptoms of anxiety and depression in children and adolescents.Total scores range from 0 to 141, with higher scores indicating greater symptom severity .
Baseline, at completion of the intervention (10 weeks) and 3 months post intervention

次要结果测量

结果测量
措施说明
大体时间
Change from baseline in Child Anxiety Life Interference Scale-Revised, Parent Version (CALIS-R) total Score at 3-Month follow-up
大体时间：Baseline, at completion of the intervention (10 weeks) and 3 months post intervention
Functional impairment related to anxiety will be assessed using the Child Anxiety Life Interference Scale-Revised, Parent Version (CALIS-R), a 16-item parent-report measure assessing the impact of the child's anxiety on functioning within and outside the family, as well as the impact on parental functioning. Total scores range from 0 to 64, with higher scores indicating greater anxiety-related interference .
Baseline, at completion of the intervention (10 weeks) and 3 months post intervention
Change From Baseline in Brief Parental Self-Efficacy Scale (BPSES) Total Score at 3-Month Follow-up
大体时间：Baseline, at completion of the intervention (10 weeks) and 3 months post intervention
Parental self-efficacy will be assessed using the Brief Parental Self-Efficacy Scale (BPSES), a five-item self-report measure evaluating parents' perceived competence and confidence in their parenting role. Total scores range from 5 to 30, with higher scores indicating greater parental self-efficacy .
Baseline, at completion of the intervention (10 weeks) and 3 months post intervention
Parent-reported experience of participation in the intervention UP-A-AST Parent Group
大体时间：At completion of the intervention (12 weeks)
Parent experiences of participating in the intervention will be assessed using the Evaluation of the UP-A-AST Parent Group, a study-specific questionnaire developed for this intervention. The questionnaire consists of six items rated on a 10-point scale, yielding a total score ranging from 0 to 60, with higher scores indicating a more positive experience of participation. The questionnaire also includes three open-ended questions regarding positive aspects of the parent group, aspects that participants would have preferred to be different, and any additional comments or reflections.
At completion of the intervention (12 weeks)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Sahlgrenska University Hospital

调查人员

  • 首席研究员：Karin Melin, PhD、Sahlgrenska University Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月5日

初级完成 (估计的)

2026年12月30日

研究完成 (估计的)

2027年3月30日

研究注册日期

首次提交

2026年3月31日

首先提交符合 QC 标准的

2026年6月9日

首次发布 (实际的)

2026年6月10日

研究记录更新

最后更新发布 (实际的)

2026年6月10日

上次提交的符合 QC 标准的更新

2026年6月9日

最后验证

2026年3月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2025-05437-01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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