NL-OMON47998招募中不适用
ongitudinal European Autism Project (LEAP). Follow-up-2 (wave-3) - LEAP-3
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 288
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational invasive
入排标准
- 年龄范围
- 2 至 99（—）
入选标准
- •Having participated in LEAP-1 and/or LEAP-2; the criteria observed at wave-1
- •1. Male or female aged 6-30 years with an established clinician diagnosis of
- •Autism Spectrum Disorder according to DSM-5 criteria;
- •2. Male or female with an IQ of 50 or above;
- •3. Able to participate and willing to give written informed consent;
- •(a) Where participants are their own legal guardian (i.e. aged 18 years and
- •older without intellectual disabilities and demonstrated capacity to consent),
- •written informed consent from the volunteer;
- •(b) Where participants are minors and/or do not have capacity to consent,
- •written informed consent from the parent or legal guardian; verbal assent from
- •the volunteer prior to each assessment; for adolescents and adults without
- •capacity to consent: additional written assent from the volunteer (easy-read
- •4. Availability of a parent or legal guardian to provide information about the
- •volunteer*s behaviour and symptoms by completing (on-line) questionnaires,
- •during the institute visit, a separate home-visit or over the telephone,
- •5. Availability of a parent or carer to accompany the volunteer to all
- •institute visits where participants are unable to travel on their own;
- •6. Participant on stable medication (min 8 weeks) at entrance point and over
- •the course of study.
- •Typically Developing (TD) control group:
- •1. Male or female aged 6-30 years;
- •2. Able to participate and willing to give written informed consent;
- •For minors <18 years: Informed written consent from the parent or legal
- •guardian, verbal assent from the volunteer prior to each assessment;
- •3. For minors <18 years: Availability of a parent who provides information
- •about behaviour/ symptoms during the institute visit, a separate home-visit or
- •over the telephone.
- •Intellectual disabilities (ID) control group:
- •1. Male or female aged 12-30 years;
- •2. Presence of syndromic forms of ID (Down*s Syndrome) and/or unspecified
- •general intellectual disabilities;
- •3. Availability of a parent or legal guardian to provide written informed
- •consent; verbal assent from the volunteer prior to each assessment;
- •4. Availability of parent or caregiver who accompanies the volunteer to all
- •institute visits and provides information about the volunteer*s behaviour and
- •symptoms by completing (on-line) questionnaires, and either during the
- •institute visit, a separate home visit, or over the telephone;
- •5. Participant on stable medication (minimum 8 weeks) prior to each assessment
排除标准
- •All groups:
- •1. Presence of significant hearing or visual impairments not correctable by
- •glasses or hearing aids;
- •2. A history of alcohol and / or substance abuse or dependence in the past
- •3. Presence of any MRI counter-indications (e.g., metal implants, braces,
- •claustrophobia) or failure to give informed written consent to MRI scanning (or
- •to provide GP details at centres where this is a pre-condition for scanning);
- •4. Presence or history of any Neurological Disorder/ significant trauma.
- •Presence of psychosis or bipolar disorder.
- •Presence of any DSM-5 axis I and II psychiatric disorders.
研究者
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