Anxiety disorders Mental and Behavioural Disorders Anxiety disorder, unspecified
Conditions
Interventions
Children (aged 8-9 years) from six primary/junior schools (2 classes per school), their parent/carer and class teacher will complete questionnaire measures at baseline and 12-week follow-up.
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Schools: 1. Primary or junior school in England with at least two Year 4 classes Feasibility trial participants: 1. Children: 1.1. Aged 8-9 years 1.2. In a participating Year 4 class 1.3. Provides assent and their parent/carer does not opt-out 1.4. Sufficient English to give assent and complete questionnaires, with assistance if necessary 2. Parent/Carer of a child in a Year 4 participating class 2.1. Provides consent. Where a parent/carer has more than one eligible child, they will be invited to consent/participate for each child. 2.2. Sufficient English to give consent, and to complete questionnaires, with assistance if necessary. 3. Class teacher of participating child or nominated member of support staff who works regularly with the child Target population: 1. Children who screen positive (score =3 on parent-report 2-item child anxiety questionnaire) at baseline, and their parent/carer
Exclusion criteria
Exclusion criteria: Does not meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Negative impacts and acceptability of study procedures measured using: 1.1. Monitoring participant reports throughout the study 1.2. A bespoke acceptability questionnaire (child-, parent-, and teacher-report) at baseline and 12 weeks 1.3. Qualitative interviews/discussion groups with children, parents/carers, and school staff throughout the study 1.4. The Study Steering Committee 2. Recruitment and retention rates measured using the number (%) of eligible participants who complete baseline and follow-up assessments, the number (%) of participants who screen positive (target population) who complete baseline and follow-up assessments, and the number (%) of participants who participate in OSI collected throughout the study 3. Relevance and acceptability of all clinical and health economic outcome measures measured using: 3.1. Proportion of missing data and patterns in missing responses/measures at baseline and 12 weeks 3.2. Descriptive statistics for each outcome measure at baseline and 12 weeks 3.3. Qualitative interviews/discussion groups with children, parents/carers, and school staff throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical outcomes measured at baseline and 12-week follow-up: 1.1. Anxiety measured using the incidence of cases above/below cut-off (score =3) on the 2-item parent report child anxiety questionnaire 1.2. Child anxiety symptoms measured using the Brief Spence Children’s Anxiety Scale (SCAS-8-child, parent, teacher report) and the Revised Children’s Anxiety and Depression Scale-anxiety scale (RCADS-A-child and parent report) 1.3. Interference caused by child anxiety measured using brief child anxiety questionnaire (child, parent, teacher-report) 1.4. Child depressive symptoms measured using the RCADS-depression scale (child and parent report) 1.5. Child emotional and behavioural problems measured using the Strengths and Difficulties Questionnaire (SDQ-child and parent report) 2. Health economic outcomes measured at baseline and 12-week follow-up: 2.1. Child quality of life measured using Child Health Utility 9D-(child and parent report) and the EQ-5D-Y (child and parent report) 2.2. Parent/carer quality of life measured using EQ-5D-5L (parent self-report) 2.3. Individual resource use (e.g. service use, time off school and work) measured using a modified version of the Client Service Receipt Inventory (CSRI)-parent/ report 2.4. Time spent on intervention delivery measured using therapist and supervisor completed logs throughout 3. Acceptability measured using a bespoke questionnaire measure (child, parent and teacher report) at 12 weeks 4. Information on children’s school attendance, punctuality, and learning will be collected from the child’s school records at 12 weeks 5. Parents questionnaires used to guide the intervention, including measures of child anxiety symptoms (RCADS, SCAS-8), interference related to the child’s anxiety (Child Anxiety Impact Scale), | — |
Countries
England, United Kingdom
Contacts
Public ContactTessa Reardon
Outcome results
None listed