Children attending special educational needs schools aged 9 – 11 years and their parents Not Applicable
Conditions
Interventions
Zippy’s Friends is a manualised, classroom-based programme that aims to develop children’s repertoire of coping skills and their ability to adapt those coping skills to various situations. ZF consists
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: SEND schools: 1. Firm commitment to the research and have agreed to be randomly allocated to either the intervention or the UP arm (either delayed or no access to ZF SEND) of the study 2. They should have pupils with ID 3. Be able to identify two teachers who consent to take part and who are willing to deliver the ZF SEND intervention over one academic year to a group of children with ID Child research participants: 1. Administratively defined with ID (learning disability/difficulty in UK services terminology) by virtue of attending a SEND school/unit in England or Scotland 2. Schools will identify prior to randomisation at least one class of children in the age range 9-11 years to receive intervention Parent participants: 1. Biological, step-, adoptive parent or foster carer or adult family caregiver of the children receiving the ZF SEND intervention or allocated to the UP arm of the research 2. Having a level of English language enabling (verbal) completion of outcome measures
Exclusion criteria
Exclusion criteria: SEND schools: 1. Delivering other manualised classroom interventions designed to address mental health, well-being, or emotional literacy Child participants: 1. No parental assent to participate in the research (although this would not exclude the child from the intervention) 2. Unable to assent to the MAMS assessment or to communicate using English (and adaptations to meet their communication needs cannot be put in place in the classroom setting) Parent participants: 1. Current child protection concerns relating to the child at the point of recruitment or the family are reported by the school to be in a state of current crisis 2. Insufficient command of the (spoken) English language to complete the outcome measures or lacking capacity to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment of schools/teachers/children/parents: recruitment rates for schools, teachers, parents and children as recorded by the number who consent to take part by 12 months 2. Acceptability of research design: willingness to be randomised within the context of an RCT measured using interview at 12 months 3. Fidelity of implementation: fidelity to the programme manual measured using a self-rated checklist during the intervention period 4. Adherence: proportion of children with ID in the intervention arm schools completing the ZF SEND programme at 12 months 5. Retention: proportion of schools, children and parents/carers retained in the research study up to the 12-month post-randomisation follow-up 6. Usual practice: definition of usual practice using interviews at 12 months 7. Estimation of parameters needed for definitive sample size calculation: estimated standard deviation, intracluster correlation coefficient, average cluster size, and coefficient of variation of cluster size for the Strengths and Difficulties Questionnaire (SDQ) calculated at 12-months post-randomisation 8. Feasibility of outcome measures: completion of study outcome measures assessed at 12 months 9. Evidence of harm: no evidence on the basis of the outcome measures that the ZF SEND programme results in harm at 12 months 10. Design and methods for health economic analysis: collection of resource use and health-related quality of life data using EQ-5D-Y and CHU-9D for parents and the child with ID at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Behavioural and emotional problems measured using the Strengths and Difficulties Questionnaire (SDQ) Total Difficulties score reported by teachers and parents at 12 months | — |
Countries
England, United Kingdom
Outcome results
None listed