Anxiety disorders Mental and Behavioural Disorders Anxiety disorder, unspecified
Conditions
Interventions
Schools will be randomised to the intervention or usual school practice arm in a 1:1 ratio stratified according to school-demographic information. An independent statistician will conduct randomisatio
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Schools: mainstream infant/primary school in England, with a minimum of two classes per target year. 2. Screening: child in Reception, Year 1 or Year 2 in a participating school (aged 4-7 years). One parent/carer will complete screening questionnaires for each child. 3. Trial: child screens positive on child anxiety symptoms, and/or behavioural inhibition, and/or parent/carer anxiety symptoms. 4. Qualitative interviews: parents/carers who take part in screening, school staff in participating schools and children of parents/carers who take part in the intervention
Exclusion criteria
Exclusion criteria: 1. Parent/carer does not have sufficient use of English to provide consent, complete measures and/or take part in the intervention 2. Parent/carer does not have frequent access to the internet, either at home or elsewhere
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absence/presence of an anxiety disorder measured using Anxiety Disorder Interview Schedule-Child Version-Parent Interview (ADIS-P) at 12-months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 21/12/2022: 1. Secondary clinical outcomes measured at baseline, 12 weeks and 12 months post-randomisation: 1.1. Child anxiety symptoms measured using the Preschool Anxiety Scale -parent/carer report 1.2. Inference caused by child anxiety measured using the Child Anxiety Life Interference Scale-Preschool version-parent/carer report 1.3. Child externalising symptoms measured using the Strengths and Difficulties Questionnaire-Externalising Scale-parent/carer report 2. Moderators of primary outcome measured at screening and baseline: 2.1. Child age, child gender, child ethnicity, parent gender, parent ethnicity, and family socioeconomic status measured using parent/carer-report bespoke socio-demographic questionnaire 2.2. Risk factors (child anxiety symptoms, behavioural inhibition, parent anxiety symptoms) and number/combination of risk factors measured using Preschool Anxiety Scale-parent/carer report, Approach subscale of the Short Temperament Scale for Children-parent/carer report, Generalised Anxiety Disorder-7 (GAD-7) Scale-parent self-report 3. Mediators of primary outcome measured at baseline, 12 weeks and 12 months post-randomisation: 3.1. Risk factors (child anxiety symptoms, behavioural inhibition, parent anxiety symptoms) measured using the Preschool Anxiety Scale-parent/carer report, Approach subscale of the Short Temperament Scale for Children-parent/carer report, Generalised Anxiety Disorder-7 (GAD-7) Scale 3.2. Additional intervention targets, including: 3.2.1. Parent overprotection measured using the Parental Overprotection Scale-parent/carer report 3.2.2. Parenting self-efficacy measured using the Parenting Sense of Competence Scale-self-efficacy subscale-parent/carer report 3.2.3. Child behavioural avoidance measured using the Child Avoidance Measure-parent/carer report 3.2.4. Child coping efficacy measured using an adapted version of the Coping Questionnaire-parent/carer report 3.2.5. Child intolerance of un | — |
Countries
England, United Kingdom
Contacts
Public ContactTessa Reardon
Outcome results
None listed