Attention deficit hyperactivity disorder (ADHD) Mental and Behavioural Disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Children: 1. Aged 6-11 years 2. on a waiting list for ADHD support post-diagnosis 3. Have sufficient understanding of English to participate in the study 4. Have parent(s) / guardian(s) with sufficient understanding of English to participate in the study Parents/guardians: 1. Parent/guardian for a child study participant 2. Has sufficient understanding of English to participate in the study 3. Is willing and able to complete the study outcome measures
Exclusion criteria
Exclusion criteria: Children: 1. Pose a risk of harm to self or others 2. Have profound additional difficulties as determined by parent(s)/guardian(s) Parents/guardians: 1. Unwilling or unable to consent or complete the study outcome measures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcomes: 1. Recruitment rate recorded as the number of eligible participants who consent to participate in the study by January 2027 (number of eligible young people, number approached, number of exclusions due to non-English speaking families, what are the common languages and how can participation be enabled in a larger study) 2. Retention rate recorded by withdrawal rates from the study up to January 2027 3. Demographics of participants recorded at baseline and 6 week follow up to see whether it is possible to recruit a diverse sample, and can balance be achieved across trial arms 4. Data completeness recorded as percent of parents and children completing the outcome measures at baseline and 6 week follow up Recording for missing data, completion rates, differential completion between arms 5. Fidelity to the intervention recorded using questionnaires at 6 week follow up to understand can the intervention be delivered with fidelity by NHS staff 6. Acceptability assessed qualitatively through semi-structured interviews after the 6 week follow up to understand whether the intervention and an RCT design are acceptable from the perspective of families, children, and staff 7. Adherence to intervention assessed using questionnaires and semi-structured interviews after the 6 week follow up to see whether children and parents/guardians engage with the intervention We will also evaluate whether the following continuation criteria have been met, prior to planning a future definitive trial: 1. Site set-up is fully achieved for two sites including site approvals obtained, staff trained to deliver intervention, open to recruitment (site greenlight) by December 2025. 2. Data completion rates of CHU9D (candidate primary outcome) at baseline and 6 weeks are at 60% or higher 3. No major concerns are identified in the delivery of the intervention or RCT by the study end (January 2027) 4. Aim to recruit 84 participants across two sites over 9 months with 3+ recruite | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility of collection of the following measures: 1. Symptoms of attention-deficit/hyperactivity disorder measured using the Swanson, Nolan, and Pelham (SNAP-IV) scale at baseline and 6-week follow up. 2. Symptoms of anxiety and depression in children and adolescents measured using the Revised Children’s Anxiety and Depression Scale (RCADS) at baseline and 6-week follow up. 3. How connected children are to the natural world measured using Nature Connection Index (NCI) at baseline and 6-week follow up 4. Bespoke acceptability and accessibility measures measured using scaled questions at 6-week follow up 5. Bespoke fidelity checklist (clinician-completed) at 6-week follow up 6. Anonymous parent-completed adherence questionnaire at 6-week follow up 7. Intervention daily diary sheet used daily by parents during the 6-week intervention period | — |
Countries
England, United Kingdom