Condition category
Injury, Occupational Diseases, Poisoning
Date applied
12/06/2017
Date assigned
13/06/2017
Last edited
13/06/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
In the UK, a child injures their brain every 30 minutes through accident or illness. Many can survive brain injury but it can lead to devastating and life-long impacts on the child and their family. Brain injury can affect thinking, emotion, behaviour and relationships. This can impact the child’s ability to cope with school, home life, future employment and independence. Families are also more likely to experience mental health difficulties and parental separation, which can further affect how well a child recovers. Researchers have developed an internet-based treatment for children who have survived such brain injuries called TUPs-UK. This treatment teaches problem-solving skills in response to specific everyday difficulties and is used at home for 10-16 weeks with weekly therapist support. Research on children with traumatic brain injury suggests that those who completed treatment, compared to those who were given general self-help, improved in their ability to plan, organise, problem-solve, and manage mood and behaviour. Families also experienced less stress and better mental health. However, there are still questions about the treatment and if it will have similar benefit for all types of brain injury (e.g.stroke, infection, tumour), if it can improve other aspects of life (e.g.improved quality of life) and if it cost effective. The aim of this study is to find out whether it is possible to identify and recruit adolescents and their families with brain injuries via the NHS, and establish if they find the treatment and research measures acceptable, in order to undertake a larger study to assess the benefit of the internet based treatment.

Who can participate?
Adolescents aged 12 to 16 who have a brain injury and executive function difficulties and their families

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive the TOPS-UK programme which they access online while they on top of the usual treatment. This required weekly one hour sessions over ten weeks (around nine months) that help adolescents develop skills to cope with problems. The participant and their parent/carer can work together and they will be supported by a weekly Skype or FaceTime session with a research coach. Any support they usually receive (for example, seeing a psychologist or speech therapist) continues as usual. Those in the second group receive the usual treatment. Participants and their families are followed up one week and six months after the programme with online questionnaires to assess how feasible and acceptable the study is. Participants are also asked to take part in a telephone interview with a research to give feedback about being in the study, and (for those who accessed the online treatment programme), how they found the programme.

What are the possible benefits and risks of participating?
There are no notable benefits with participating. Participants may feel tired when completing the TOPS-UK programme or questionnaires. There are risks of this study leading to disagreements within the family however there will be a TOPS-UK coach available to help the family.

Where is the study run from?
This study is being run by the University of Plymouth (UK) with Royal Devon and Exeter Hospital (UK) as its lead site.

When is the study starting and how long is it expected to run for?
December 2016 to March 2019

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Alison Jeffery
alison.jeffery@plymouth.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Alison Jeffery

ORCID ID

Contact details

Peninsula Clinical Trials Unit
N16/17
ITTC Building 1
Plymouth Science Park
Plymouth University
Plymouth
PL6 8BX
United Kingdom
+44 1752 315251
alison.jeffery@plymouth.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

31846

Study information

Scientific title

The clinical and cost-effectiveness of Teen Online Problem Solving for adolescents who have survived a brain injury in the UK: A feasibility study

Acronym

TOPS-UK

Study hypothesis

The aim of this study is to find out whether it is possible to identify and recruit adolescents and their families with brain injuries via the NHS, and establish if they find the treatment and research measures acceptable, in order to undertake a larger study to assess the benefit of the internet based treatment.

Ethics approval

South West Exeter Research Ethics Committee, 05/06/2017, ref: 207736

Study design

Randomised; Interventional; Design type: Treatment, Education or Self-Management, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Children, Primary sub-specialty: General Paediatrics; UKCRC code/ Disease: Injuries and Accidents/ Injuries to the head, Neurological/ Other disorders of the nervous system

Intervention

Following consent and confirmation of eligibility, participants are allocated to either the treatment or control arm (50:50 ratio) via a web-based system provided by the CTU in conjunction with the trial statistician. Participants (both adolescent and parent), the site research nurse, CTU trial managers and the trial coach (therapist) are informed of the treatment allocation.

Treatment arm: Participants receive the TOPS-UK programme. This is a web-based programme followed weekly by the adolescent and his/her family. The weekly sessions take about one hour each, and help the adolescent to develop skills to cope with everyday problems. These include compulsory sessions on staying positive, steps to problem solving, getting organised, staying in control and taking care of yourself. The adolescent can then choose a further four sessions to suit their own situation from a choice of dealing with fatigue, fear and worry, anger control and communication, listening, talking and reading non-verbal cues, social behaviour and groups, working with school. The final session for all participants summarises the key points from the course. A therapist helps the adolescent and his/her family through weekly Skype or FaceTime calls.

Control arm: Participants receive their usual support only, with no access to the online programme.

The study lasts 16 weeks. The adolescent and his/her family complete 10 sessions, each session lasting one to two weeks, thus allowing time for holidays, illness or to recap a session if necessary. The first follow up is at 17 weeks following randomisation (one week after completion of the intervention programme for those in that arm, and equivalent time for control group). Follow up comprises completion of questionnaires online by both adolescent and parent. All families in the treatment arm are asked to participate in qualitative interviews by telephone to ascertain study acceptability and feedback about study participation. A selection of 10 families in the control arm are also asked to participate in qualitative telephone interviews to feedback their views on study participation.

The second follow up will be at six months after completion of the first follow up questionnaires. The online questionnaires will be repeated. A subset of 10 families from the treatment arm will be invited to participate in another qualitative telephone interview.

Intervention type

Other

Phase

Drug names

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 outcome measures

There are no secondary outcome measures.

Overall trial start date

01/12/2016

Overall trial end date

31/03/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 12 – 16 years
2. Acquired brain injury, including moderate-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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 50; UK Sample Size: 50

Participant 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

Recruitment start date

01/07/2017

Recruitment end date

28/02/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Devon and Exeter Hospital (Lead site)
Barrack Road
Exeter
EX2 5DW
United Kingdom

Trial participating centre

Cambridge Centre for Paediatric Neuropsychological Rehabilitation (CCPNR)
Brookside Clinic 18D Trumpington Road
Cambridge
CB2 8AH
United Kingdom

Trial participating centre

John Radcliffe Hospital
Headley Way Headington
Oxford
OX3 9DU
United Kingdom

Trial participating centre

University Hospital Southampton
Tremona Road
Southampton
SO16 6YD
United Kingdom

Trial participating centre

Queen’s Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

Royal Devon & Exeter Hospital

Sponsor details

Barrack Road
Exeter
EX2 5DW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The study team will prepare a plain English summary of the study results, which will be sent to the study participants as soon as possible after the end of the study.

The final results of the study will be disseminated via presentations at appropriate scientific meetings and conferences (e.g. International Paediatric Brain Injury Society, International Neuropsychological Society, World Federation for Neuro-Rehabilitation) and publication in appropriate peer-reviewed journals (e.g. Neuropsychological Rehabilitation, Journal of Head Trauma Rehabilitation or Developmental Medicine and Child Neurology).

IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/03/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes