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临床试验/NCT05938751
NCT05938751已完成不适用

A Multicentric Mixed-methods Study About the Promotion of Self-determination in Young Adults With Autism: the TEAm_YOUNG ADULTS Program

University Ramon Llull4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
4
主要终点
Self-determination (Qualitative measure)

研究概览

简要总结

The goal of this clinical trial is to test the benefits of a program to develop self-determination in young adults with autism. Being self-determined means acting or causing things to happen in your life. It involves deciding, acting and believing in one-self.

The main question this clinical trial aims to answer is: Is the program developed useful to improve self-determination of young adults with autism?

Participants will receive a group intervention to support the development of their self-determination-related skills during 20 sessions (1 session/week).

Researchers will compare the self-determination outcomes between the group that receives the intervention and another group that is in a waiting list (and will receive the intervention later) to see if the changes are due to the intervention.

详细描述

This clinical trial employed a convergent mixed methods design. Quantitative and qualitative data were collected from the same participants and analyzed separately within a similar timeframe. The quantitative strand used self-reported and proxy-reported questionnaires to evaluate the impact of the TEAm_YOUNG ADULTS program on the self-determination of young adults with autism. The quantitative data was collected at baseline and at the completion of the program, after 5 months (20 sessions). In the qualitative strand, focus groups were used to explore changes in self-determination perceived by the participants that received the program and their acceptance of the intervention. The focus groups were conducted when finishing the group and after the self-reported questionnaires are answered. Proxy-reports were answered after the realization of the focus groups.

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

盲法说明

Masking was not possible due to the resources of this study.

入排标准

年龄范围
17 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • To have a diagnosis of autism spectrum disorder in accordance with the criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5), or of Asperger's syndrome, according to he DSM-IV
  • To be between 17 and 30 years old.
  • To have a verbal comprehension index higher than 70 in the Wechsler Adult Intelligence Scale-IV (WAIS-IV), to ensure a good comprehension of the program

排除标准

  • Not having spoken language
  • Having a condition that could significantly interfere in the group functioning, such as an acute psychotic disorder or challenging behavior

结局指标

主要结局

Self-determination (Qualitative measure)

时间窗: After the completion of the intervention (20 weeks later)

Focus groups to evaluate the changes after the completion of the intervention. Questions related to the three dimensions of self-determination will be asked (volitional action, agentic action and action-control beliefs) in accordance with the quantitative measures to allow a joint display of the results following a mixed methodology (quantitative and qualitative). The focus groups will only be conducted for the intervention groups.

Change from baseline Self-determination after 20 sessions (Quantitative measure: proxy-report)

时间窗: At baseline and after the completion of the intervention (20 weeks later)

AUTODDIS Scale. It is a proxy-report measure that evaluates the three dimensions of self-determination based on Causal Agency Theory (volitional action, agentic action and action-control beliefs) as well as the total self-determination scores. The internal consistency of these sections was excellent (between α = .948 to α = .962), as well as for the entire scale (α = .983), and there is also evidence of its validity.

Change from baseline Self-determination after 20 sessions (Quantitative measure: self-report)

时间窗: At baseline and after the completion of the intervention (20 weeks later)

Self-Determination Inventory: Student Report (SDI:SR). The Spanish adaptation was used. It is a self-report measure that evaluates the three dimensions of self-determination based on Causal Agency Theory (volitional action, agentic action and action-control beliefs) as well as the total self-determination scores.

次要结局

未报告次要终点

研究者

发起方
University Ramon Llull
申办方类型
Other
责任方
Principal Investigator
主要研究者

Clara Andrés Gárriz

Principal Investigator

University Ramon Llull

研究点 (4)

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