Insomnia and ADHD (attention deficit hyperactivity disorder) Mental and Behavioural Disorders
Conditions
Interventions
Randomisation process
Following informed consent, completion of screening, baseline measurements, and confirmation of eligibility by the Hub RA, participants will be randomised as part of the online p
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Child aged 6-12 years inclusive 2. Diagnosis of ADHD (including ADD) 3. Child meets the criteria for chronic insomnia based on primary carer report (sleep onset latency > 30 minutes for > 3 nights/week for > 3 months) 4. Sufficient understanding of English by primary carer to allow access to the digital sleep intervention (our digital interventions are aimed at a reading age of 11y so will be accessible to adults with English as a second language)
Exclusion criteria
Exclusion criteria: 1. Child has sleep-related rhythmic movement disorder 2. Child has severe learning disabilities 3. Child with physical ill health or disability likely to require admission to hospital during the 6-month trial period 4. Child with long term health problems that affect their sleep. (e.g. severe eczema or epilepsy) 5. Primary carer has participated in the DISCA study ‘think aloud’ interviews during Sleep Buddy development
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep Onset Latency is measured using a parent-completed 10-day sleep diary at Baseline and month 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sleep Onset Latency is measured using a parent-completed 10-day sleep diary at Baseline and Month 6 2. Sleep Quality is measured using a parent-completed SASS-Y at Baseline, Month 3 and Month 6 3. Subjective report of child sleep is measured using SNAP-IV parent report at Baseline, Month 3 and Month 6 4. Irritability is measured using the Affective Reactivity Index (ARI) at Baseline, Month 3 and Month 6 5. Mental well-being is measured using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) at Baseline, Month 3 and Month 6 6. Sleep problem score (parent report) is measured using the Omnibus Sleep Questionnaire (OSQ) at Baseline and Month 6 7. Quality of life of parent is measured using EQ-5D-5L at Baseline, Month 3 and Month 6 8. Quality of life of child is measured using the Child Health Utility 9D index (CHU-9D) proxy for children aged 7 to 12 at Baseline, Month 3 and Month 6 9. Working memory is measured using a 2-back working memory task at Baseline, Month 3 and Month 6 10. Selective attention and motor response inhibition are measured using a Go/No-Go task at Baseline, Month 3 and Month 6 11. Sustained attention and vigilance on detection of rare signals are measured using the Mackworth Clock task at Baseline, Month 3 and Month 6 12. Continuous performance variables are measured using a CPT task at Baseline, Month 3 and Month 6 Process Evaluation 1. Parent enablement will be measured using the Patient Enablement Instrument (PEI) at Baseline, Month 3 and Month 6 2. Intervention acceptability will be measured using the Theoretical framework of acceptability (TFA) at Month 3 3. Engagement with the intervention will be measured by intervention usage over the 6-month intervention period Qualitative Interviews Qualitative process interviews will be carried out with 25-30 trial participants to provide in-depth understanding of participant experiences within the trial and provide a better understanding of factors that may influence eng | — |
Countries
England, United Kingdom
Contacts
Public ContactAlannah Morgan
Outcome results
None listed