Specialty: Children, Primary sub-specialty: General Paediatrics
Conditions
Interventions
Current intervention as of 06/12/2018:
Following consent and confirmation of eligibility, participants are allocated to either the treatment or control arm (50:50 ratio) via a web-base
Sponsors
Royal Devon & Exeter Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 10/05/2018: 1. Aged 12-18 years 2. Acquired brain injury, including moderate-to-severe TBI 3. Medically stable post-injury/illness onset with cognitive recovery having plateaued 4. Acute medical treatments for primary diagnosis completed 5. Executive function difficulties in the opinion of the local principal investigator 6. Access to the internet 7. Availability of at least one parent/guardian who lives with the adolescent to participate in the study Previousparticipant inclusion criteria as of 10/05/2018: 1. Aged 12-18 years 2. Acquired brain injury, including moderate-to-severe TBI 3. Medically stable post-injury/illness onset with cognitive recovery having plateaued 4. Acute medical treatments for primary diagnosis completed 5. Executive function difficulties as reported by parents on BRIEF-2 6. Access to the internet 7. Availability of at least one parent/guardian who lives with the adolescent to participate in the study Previous participant inclusion criteria: 1. Aged 12-16 years 2. Acquired brain injury, including moderate-to-severe TBI 3. Medically stable post-injury/illness onset with cognitive recovery having plateaued 4. Acute medical treatments for primary diagnosis completed 5. Received treatment for acquired brain injury within last 5 years 6. Executive function difficulties as reported by parents on BRIEF-2 7. Access to the internet 8. Availability of at least one parent/guardian who lives with the adolescent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Insufficient English language or capacity for the parent/child to consent/assent to the study 2. Pre-injury or co-morbid conditions such as sensory impairments and global developmental delay, known to impair engagement with the computer and treatment materials 3. Non-accidental brain injury
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 10/12/2018: Feasibility of assessing executive function using Behavior Rating Inventory of Executive Function Second Edition (BRIEF-2) completed by parents 17 weeks after randomisation. Executive function assessed using BRIEF-2 is the proposed primary outcome measure for the main trial. Previous primary outcome measure as of 06/12/2018: Executive function assessed using Behavior Rating Inventory of Executive Function Second Edition (BRIEF-2); completed by parents at 17 weeks. This is the proposed primary outcome measure for the main trial. Previous primary outcome measures: Intervention adherence, feasibility, acceptability and study participation are measured using online questionnaires (non-validated) and telephone interviews at 17 weeks and six months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 10/12/2018: 1. Clinician ability to identify participants 2. Feasibility of online screening, consent and randomisation processes 3. Recruitment rate; proportion of eligible patients identified that are recruited 4. Willingness of families to be randomised and complete outcome measures assessed by questionnaire 17 weeks after randomisation and by telephone interviews with families after completion of outcome measures 5. Adolescent and parent acceptability of intervention and outcomes assessed using intervention acceptability questionnaires (adolescent and parent) 17 weeks after randomisation and telephone interviews after completion of outcome measures 6. Coach’s experience of intervention assessed using telephone interview with coach once all TOPS-UK participants have completed intervention 7. Intervention adherence and losses to follow-up assessed using records taken by coach of participation in weekly Skype sessions and use of intervention website (frequency, duration, progression) captured automatically by database throughout 16-week intervention period 8. Completeness of outcome and resource use data collected 9. Parents’ and adolescents’ experiences of study participation assessed using study participation questionnaires and telephone interviews (adolescent and parent) completed after the end of the trial Previous secondary outcome measures added 06/12/2018: 1. Clinician ability to identify participants 2. Feasibility of online screening, consent & randomisation processes 3. Recruitment rate; proportion of eligible patients identified that are recruited 4. Willingness of families to be randomised and complete outcome measures 5. Adolescent and parent acceptability of intervention and | — |
Countries
United Kingdom
Contacts
Public ContactAlison Jeffery
Outcome results
None listed