Validation Study of the Coping, Motivation Ans Post-diagnosis Psychoeducation Program for Adults With Autism : a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- General Self-Efficacy Scale
研究概览
简要总结
The primary objective of the study is to evaluate the effectiveness of a post-diagnostic psychoeducational intervention in increasing the sense of self-efficacy of adults diagnosed with Autism Spectrum Disorder-Without associated Intellectual Disability
详细描述
Secondary objectives
The other objectives of this study are :
- To evaluate the effectiveness of the intervention on self-esteem ;
- To evaluate the effectiveness of the intervention on anxiety-depressive symptomatology ;
- To evaluate the effectiveness of the intervention on the acceptance of the diagnosis ;
- To evaluate the acceptance of the intervention.
Conduct of research The study will be offered to individuals diagnosed with autism spectrum disorder without associated intellectual developmental disabilities in adulthood.
After signing the consent form and verifying the eligibility criteria, participants will be randomized into the waiting list group or the intervention group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant aged 18 years and older at the time of inclusion in the study
- •Participant with a diagnosis of Autism Spectrum Disorder - Without associated Intellectual Disability (intelligence quotient > 80) made by a specialized 2nd (1) or 3rd (2) line team according to the recommendations of the Haute Autorité de la Santé (HAS)
- •Diagnosis of Autism Spectrum Disorder - Without associated Intellectual Disability obtained in adulthood (≥ 18 years) within 15 months prior to inclusion
- •Participant able to understand the objectives and risks of the research and having signed a consent to participate in the study
- •Participant affiliated with a social security plan or beneficiary of such a plan
- •Psychiatric teams (psychiatric services including medical-psychological centers), care networks specialized in the diagnosis and evaluation of autism or private practitioners coordinated by a physician.
- •Professionals working in autism resource centers or hospitals for additional specialized medical advice, particularly in clinical genetics and medical imaging.
排除标准
- •Participant not sufficiently available to participate in the intervention
- •Participant in full hospitalization
- •Participant co-morbid with schizophrenia or other psychotic disorder according to DSM-5 criteria
- •Impossibility of giving the participant informed information (participant in an emergency or life-threatening situation, difficulties in understanding the participant, insufficient command of the French language)
- •Participant under court protection or deprived of liberty by judicial or administrative decision
- •Participant under guardianship or curatoship
- •Diagnosed with Autism Spectrum Disorder - Without associated Intellectual Disability in childhood or adolescence or in a period of more than 15 months prior to inclusion
结局指标
主要结局
General Self-Efficacy Scale
时间窗: Change from inclusion result at 8 months
It is a unidimensional scale that assesses beliefs in one's ability to achieve goals and to cope with and/or adapt to various situations that may arise in daily life. This measure consists of 10 items rated on a 4-point Likert scale (1= "not at all true" ; 4 = "completely true"). Overall scores range from 10 to 40, with higher scores indicating a greater sense of self-efficacy.
次要结局
- Acceptance and Action Questionnaire_Version 2(Through study completion , an average of 8 months)
- Self-Esteem Scale(Through study completion , an average of 8 months)
- Social validity measures (in-house questionnaires)(Through study completion , an average of 8 months)
- qualitative data (semi-structured interviews)(Through study completion , an average of 8 months)
- Depression Anxiety Stress Scale(Through study completion , an average of 8 months)