Investigating the clinical and cost-effectiveness of self-care support in children with neurodisability Mental and Behavioural Disorders
Conditions
Interventions
The trial will evaluate CHESS (CHildren's Early Self-care Support), a multi-component behaviour change intervention, compared to usual children's community NHS therapy (occupational therapy, physiothe
i.e. there is no random allocation of individual children.
Eligible children (and their parents) will be identified from their local NHS caseloads at each site (cluster) and a random subset will be a
Sponsors
Sheffield Children's NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
12 Months to 54 Months
Inclusion criteria
Inclusion criteria: 1. Any child with neurodisability 2. Age at least 12 months and not older than 4 years 6 months on the date of sampling 3. Seen by at least one paediatric community/outpatient therapy service 4. Where self-care support is indicated 5. Where the family and therapist agree on a need for self-care intervention 6. Who has been randomly sampled for data collection from the participating therapists’ caseloads 7. Whose parent is willing to consent to data collection and comply with study procedures No restriction is placed on child mobility, cognitive, or communication capacities. The sample is expected to include a mix of children across these capacities due to the nature of caseloads and random sampling.
Exclusion criteria
Exclusion criteria: 1. Children with no neurodisability 2. Children with only sensory impairment (e.g. visual, hearing) 3. Children with a degenerative condition(s) 4. Children with no clear self-care problems or goals 5. Children receiving one-off advice and discharge only 6. Children who are hospitalised or in end-of-life care 7. Children with a sibling already participating in the CHESS trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The clinical effectiveness of CHESS compared with usual care, on self-care skills and involvement for young children with neurodisability will be measured using parent-reported Pediatric Evaluation of Disability Computer Adaptive Testing (PEDI-CAT) Activities Of Daily Living module 12 months after the start of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Self-care involvement within dynamic child-caregiver interactions, with a focus on the child’s agency, comfort, stress, and psychological safety, measured using the Vineland-3 coping skills subdomain at baseline, 6 and 12 months 2. Child health-related quality of life will be measured using the Child Health Utility instrument (CHU9D) at baseline, 6 and 12 months (a version of this has been developed suitable for preschool children) 3. Caregiver health capturing health impacts on carers and allow calculation of QALYs will be measured using the generic health survey Short Form-36 version 2 (SF-36v2) at baseline, 6 and 12 months 5. Carer care-related quality of life will be measured using the ICECAP Carer Experience Scale (CES). Chosen to capture aspects of carer quality of life beyond health likely to be affected by the intervention at baseline, 6 and 12 months 6. Potential risks and harms, including physical injury for the child and parent and other potential harms, measured using data identified via the harms reporting process and process evaluation 8. Satisfaction with treatment measured using the 12-month questionnaire and process evaluation 9. Health and social care service use measured using a Service Use Questionnaire (SUQ) at baseline, 6 and 12 months 10. Cost for carers/families for accessing services and purchased care measured using a Time and Travel Questionnaire (TTQ) at 9 months 11. An embedded evaluation of recruitment, intervention acceptability, and implementation to support trial delivery, will be conducted through process evaluation interviews with parents and site staff of the study process and acceptability (throughout the study) | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactHolly Keir
Outcome results
None listed