A parent-led intervention for anxiety in autistic children with severe to profound intellectual disability: A development and proof of concept study
- Conditions
- Anxiety symptoms displayed by autistic children aged 4-15 with intellectual disabilityMental and Behavioural Disorders
- Registration Number
- ISRCTN39055689
- Lead Sponsor
- Aston University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Parent report of daily child anxiety completed daily via an anxiety daily diary
- Secondary Outcome Measures
Name Time Method