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A parent-led intervention for anxiety in autistic children with severe to profound intellectual disability: A development and proof of concept study

A parent-led intervention for anxiety in autistic children with severe to profound intellectual disability: A multiple baseline study of a novel intervention

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN39055689
Enrollment
20
Registered
2021-07-19
Start date
2021-10-01
Completion date
Unknown
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety symptoms displayed by autistic children aged 4-15 with intellectual disability Mental and Behavioural Disorders

Interventions

Current interventions as of 15/11/2021: After screening and initial contact, eligibility will be assessed, and informed consent will be obtained. Eligible participants will enter the baseline phase of

Sponsors

Aston University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

MeasureTime frame
Parent report of daily child anxiety completed daily via an anxiety daily diary

Secondary

MeasureTime frame
Current secondary outcome measures as of 04/05/2022: 1. Researcher observed child anxiety observed at Weeks 2, 9,14 and 24 2. Parent-reported child mental health symptomology measured using the Mood Interest and Pleasure Questionnaire, the Anxiety Depression and Mood Scale and the Clinical Anxiety Screen for Intellectual Disability measured at Weeks 1, 16, and 24 3. Parent-reported Child sensory processing measured by the Sensory Experience Questionnaire at Weeks 1, 16, and 24 4. Parent-reported child repetitive behavior measured by the Repetitive behavior Questionnaire at Weeks 1, 16, and 24 5. Parent report of child behaviors that challenge measured by the Challenging Behavior Questionnaire at Weeks 1, 16, and 24 6. Parent report of their own well-being measured by the Hospital Anxiety and Depression Scale at Weeks 1, 16, and 24 7. Parent report of their ability to manage anxiety measures by the Controllability Beliefs Scale at Weeks 1, 16, and 24 8. Parent-reported impact of anxiety on family functioning measured by the Child Anxiety Life Interference Scale completed weekly during intervention at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 16 9. Teacher report daily child anxiety completed daily via an anxiety daily diary to provide convergent validity of parent report data 10. Parent-reported acceptability and continued use of learnt strategies measured by qualitative interviews at Weeks 16 and 24 11. Parent report of child sleep behaviours measured by the Children’s Sleep Habits Questionnaire (CSHQ) at Weeks 1, 16, and 24 Previous secondary outcome measures: 1. Researcher observed child anxiety observed at Weeks 2, 9, 11 and 14 (updated 15/11/2021: observed at Weeks 2, 9, 11, 14 and 24) 2. Parent-reported child mental health symptomology measured using the Mood Interest and Pleasure Questionnaire, the Anxiety Depression and Mood Scale and the Clinical Anxiety Screen for Intellectual Disability measured at Week 1, Week 16 and Week 24 3. Parent

Countries

England, United Kingdom

Contacts

Public ContactJane Waite
j.waite@aston.ac.uk+44 (0)121 204 4307

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026