A study to test the methods and costs of an online programme for adolescents who have survived a brain injury: Teen online problem solving (TOPS-UK)

Not Applicable

Completed

• Conditions: Specialty: Children, Primary sub-specialty: General Paediatrics; UKCRC code/ Disease: Injuries and Accidents/ Injuries to the head, Neurological/ Other disorders of the nervous system; Injury, Occupational Diseases, Poisoning; Brain injury

• Registration Number: ISRCTN10906069
• Lead Sponsor: Royal Devon & Exeter Hospital

Brief Summary

2019 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/31444185 (added 27/08/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-13
• Study Completion: 2019-03-31
• Last Update Posted: 6 April 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measure as of 10/12/2018:<br> 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.<br><br> Previous primary outcome measure as of 06/12/2018:<br> 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.<br><br> Previous primary outcome measures:<br> Intervention adherence, feasibility, acceptability and study participation are measured using online questionnaires (non-validated) and telephone interviews at 17 weeks and six months.<br><br>