ISRCTN39055689已完成未知
A parent-led intervention for anxiety in autistic children with severe to profound intellectual disability: A multiple baseline study of a novel intervention
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 15/11/2021:
- •1. Parent/carers of children 4 -15 years with a clinical diagnosis of autism or meeting cut-off for autism on the Social Communication Questionnaire
- •2. Parent/carers of children who speak few words or odd words only on the Wessex Questionnaire (added 20/07/2021: this is for initial screening purposes. The presence of intellectual disability will be assessed during the baseline assessment stage of the intervention)
- •3. Parent report that child experiences anxiety on ‘more days than not’ or reports that anxiety significantly impacts their quality of life on a weekly basis
- •4. Parents report that their child engages in avoidance or escape behaviour in response to situations that appear to be related to the child’s anxiety. A consensus decision on the functionality of behaviours will be made by the PI (Dr Jane Waite; Clinical Psychologist) and Dr Joanne Tarver.
- •5. Parent agrees to child’s GP and psychology/behavioural/psychiatry team (if applicable) being advised of involvement in the study.
- •6. Child currently living with consenting parent/carer full-time
- •Previous inclusion criteria:
- •1. Parent/carers of children 4 -12 years with a clinical diagnosis of autism or meeting cut-off for autism on the Social Communication Questionnaire
- •2. Parent/carers of children who speak few words or odd words only on the Wessex Questionnaire (added 20/07/2021: this is for initial screening purposes. The presence of intellectual disability will be assessed during the baseline assessment stage of the intervention)
- •3. Living within 2 hours of Aston University (for pragmatic reasons it will not be feasible for the research team to travel further than this on a weekly basis)
- •4. Parent report that child experiences anxiety on ‘more days than not’ or reports that anxiety significantly impacts their quality of life on a weekly basis
- •5. Parents report that their child engages in avoidance or escape behaviour in response to situations that appear to be related to the child’s anxiety. A consensus decision on the functionality of behaviours will be made by the PI (Dr Jane Waite; Clinical Psychologist) and Dr Joanne Tarver.
- •6. Parent agrees to child’s GP and psychology/behavioural/psychiatry team (if applicable) being advised of involvement in the study.
- •7. Child currently living with consenting parent/carer full-time
排除标准
- •Current exclusion criteria as of 15/11/2021:
- •1. Child has started any medication within 6 weeks of baseline measurement for any psychiatric diagnosis or for behavioural management reasons or there are planned medication changes for the duration of the intervention period
- •2. Child is in receipt of current focused regular input (fortnightly or more) from a clinical psychologist or related team specifically for anxiety, or that such input is planned to start during the time that the child is enrolled in the intervention
- •3. Current social services involvement with family for the purposes of child protection (active safeguarding concerns)
- •4. Parent/carers who do not have sufficient literacy to understand study questionnaires or engage in research related activities
- •5. Improvements in anxiety during baseline period (i.e., a negative trend during the baseline period)
- •Previous exclusion criteria:
- •1. Child has started any medication within 6 weeks of baseline measurement for any psychiatric diagnosis or for behavioural management reasons or there are planned medication changes for the duration of the intervention period
- •2. Child is in receipt of current focused regular input (fortnightly or more) from a clinical psychologist or related team specifically for anxiety, or that such input is planned to start during the time that the child is enrolled in the intervention
- •3. Current social services involvement with family for the purposes of child protection (active safeguarding concerns)
- •4. Parent/carers who do not have sufficient literacy to understand study questionnaires or engage in research related activities
- •5. Improvements in anxiety during baseline period (i.e., a negative score is calculated when subtracting median week 3 anxiety from median week 2 and the participant has shown a 6-point reduction on subscales of the ADAMS)
研究者
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