Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001615471
Ethics application status
Approved
Date submitted
13/11/2016
Date registered
22/11/2016
Date last updated
15/09/2020
Date data sharing statement initially provided
26/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study of a teleheath intervention (Teen Online Problem Solving -TOPS) aimed at improving adolescent behavioural outcomes and family functioning following traumatic brain injury (TBI)
Scientific title
A pilot study of a teleheath intervention (Teen Online Problem Solving -TOPS) aimed at improving adolescent behavioural outcomes and family functioning following traumatic brain injury (TBI)
Secondary ID [1] 290229 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury 300416 0
Condition category
Condition code
Neurological 300277 300277 0 0
Other neurological disorders
Injuries and Accidents 300807 300807 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention known as 'Teen Online Problem Solving' (TOPS) is a family online cognitive behavioural therapy for teenagers s who have experienced traumatic brain injury and their families. Developed in the USA, TOPS has been evaluated and adapted for use in New Zealand. Participants identified via existing TBI rehabilitation service providers will be randomly allocated to either TOPS and usual care (n=10), or usual care only.

The TOPS program consists of 10 (approximately 1-hour) core online sessions that provide training in the topics of stress management, problem solving, communication and self regulation. Using a cognitive behavioural therapy approach, training and education is delivered in the form of online written exercises (i.e., goal setting), videos of adolescents sharing their experiences and strategies, and videos of role play examples. There is an emphasis on self-monitoring by the adolescent, and parental monitoring and support. The sessions are completed by the adolescent with TBI and, if possible, at least one immediate family member such as their main parent/caregiver.
Each topic is explored in various ways, such as videos of adolescents discussing how TBI affected them and the coping strategies they use; video scenarios that the participant anaylses and reports on (e.g. how the actor used techniques taught in the online session to behave more appropriately); and question-and-answer tasks/activities that provide an opportunity to practice the skills taught in that session (e.g. re-writing statements so they are less likely to lead to anger).

Each online session is accompanied by an online therapy session using Skype (or similar). Each of the 10 core sessions has an accompanying online session with a TOPS trained therapist, the adolescent with TBI and a parent/caregiver. Ideally, each accompanying Skype session will be conducted within the same week as completion of the related online session. Each online session is expected to run for approximately 1 hour, depending on the needs of each participating adolescent and their family (i.e., some sessions may be more relevant and therefore warrant more time). During this time the therapist will review educational content and assist the family in setting, revisiting and developing strategies to achieving identified goals. Adherence to intervention will be discussed with the family during each online session, with notes recorded by the TOPS therapist.

The treatment time-frame will be approximately 8 hours per participant, spread over an 10-12 week period. Follow-up assessment 1 will be administered within 7 days after treatment completion. Follow-up assessment 2 (final) will take place 4 weeks later to assess any maintenance of preliminary treatment effects and overall satisfaction ratings.
Intervention code [1] 296006 0
Rehabilitation
Intervention code [2] 296429 0
Treatment: Other
Comparator / control treatment
The comparator/control treatment will be an active control in the form of usual-care provided by the TBI service provider. This consists of the ordinary services provided by involved TBI service providers in New Zealand based on their assessment of the individual case. For example, this may involve training for independence, psychological services and support, and interventions that focus on getting the individual back to work/education, school support, among other programs.
Control group
Active

Outcomes
Primary outcome [1] 299756 0
To examine the feasibility of using TOPS in NZ. Feasibility will be assessed by examining the following processes and/or study data - establishment of recruitment site/s, participant referrals, eligibility checks, recruitment rate, randomisation, participant adherence to study processes (i.e., completion of homework, engagement with online materials, etc), online therapy delivery (i.e., number of sessions completed), technical difficulties, monitoring of any participant withdrawals, completion of baseline and follow-up assessments.
Timepoint [1] 299756 0
Feasibility data will be collated for each participant at the conclusion of their involvement in the study (i.e., 4-weeks after the completion of treatment).
Secondary outcome [1] 328035 0
To examine parent/caregiver satisfaction with TOPS and usual OR usual care alone. This outcome will be assessed at 4-weeks after completion of treatment. Satisfaction with TOPS will be assessed using an online satisfaction survey questionnaire, and study-specific program and technology questionnaires. Information concerning each participant's prior experience with technology will also be collected. Satisfaction with usual care will be assessed using a study specific questionnaire.
Timepoint [1] 328035 0
Satisfaction data will be collected at the second (final) follow-up assessment that will take place at 4-weeks after the completion of treatment.
Secondary outcome [2] 329539 0
To examine adolescent satisfaction with TOPS and usual OR usual care alone. This outcome will be assessed at 4-weeks after completion of treatment. Satisfaction with TOPS will be assessed using an online satisfaction survey questionnaire, and study-specific program and technology questionnaires. Information concerning each participant's prior experience with technology will also be collected. Satisfaction with usual care will be assessed using a study specific questionnaire.
Timepoint [2] 329539 0
Satisfaction data will be collected at the second (final) follow-up assessment that will take place at 4-weeks after the completion of treatment.
Secondary outcome [3] 329540 0
To examine the preliminary efficacy of TOPS for teens with TBI and their families. This will be assessed by examining pre and post scores on a range of standardised measures to assess child behaviour, executive function, and family functioning. Study measures include the Hospital Anxiety and Depression Scale, Symptoms Checklist-90-Revised, Strengths and Difficulties Questionnaire, Behaviour Rating Inventory of Executive Function, and Conflict Behaviour Questionnaire. Multi-informant data will be collected from children with TBI and one of their parents.
Timepoint [3] 329540 0
Using a repeated measures design, the above measures will be administered at i) baseline, ii) after the completion of treatment (approximately 10-12 weeks), and iii) 4-weeks later.

Eligibility
Key inclusion criteria
Adolescents (11-18 years at injury) with a mild to moderate traumatic brain injury (TBI) sustained within the last 24 months; teen must reside with a parent with high speed internet access; and parent-reported behavioural difficulties post-TBI.
Minimum age
11 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Adolescents with a history of significant cognitive impairment (less that 70 as defined by standardised cognitive testing), and/or congenital abnormalities preventing active participation. Families where the parent has recently had prolonged hospitalisation for psychiatric problems. Non-English speaking families will also be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Whether participants are included/excluded in the study will be determined by a research assistant (RA) following initial referral by the TBI rehabilitation service provider. The RA is not involved in the subsequent allocation of new participants to the TOPS and usual care treatment or usual care only groups. If a potential participant meets inclusion criteria, the participant will be randomly allocated to either TOPS and usual care or just usual care via a computer program, i.e. allocation is concealed via computer randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised minimization randomisation using QMinim
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Group assignment will be balanced for age group, gender and severity of injury (mild or moderate).
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
9/01/2017
Actual
3/07/2017
Date of last participant enrolment
Anticipated
Actual
3/07/2017
Date of last data collection
Anticipated
31/12/2020
Actual
3/09/2017
Sample size
Target
20
Accrual to date
Final
1
Recruitment outside Australia
Country [1] 8267 0
New Zealand
State/province [1] 8267 0
Auckland

Funding & Sponsors
Funding source category [1] 294591 0
University
Name [1] 294591 0
School of Public Health & Psychosocial studies, Auckland University of Technology
Country [1] 294591 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Auckland University of Technology
Private Bag 92006
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 293461 0
Other
Name [1] 293461 0
ABI Rehabilitation
Address [1] 293461 0
180 Metcalfe Street
Ranui
Auckland 0612
New Zealand
Country [1] 293461 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296046 0
National Health & Disability Ethics Committee
Ethics committee address [1] 296046 0
Ministry of Health
Ethics Department
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 296046 0
New Zealand
Date submitted for ethics approval [1] 296046 0
28/11/2016
Approval date [1] 296046 0
02/02/2017
Ethics approval number [1] 296046 0

Summary
Brief summary
This is a pilot randomised controlled, prospective clinical trial of a family online cognitive behavioural treatment program adapted to New Zealand, for teens with mild or moderate traumatic brain injury (TBI) and their families. Our primary purpose is to examine the feasibility of using an adapted version of Teen Online Problem Solving (TOPS) in New Zealand. Secondary aims are to examine satisfaction and preliminary efficacy for teens and their families. Adolescents (aged 11-18 years) and a parent/caregiver will be recruited via involved TBI service providers and assigned to either TOPS and usual care (n=10) or usual care alone (n=10).

Key research questions include: Is implementation of TOPS feasible within an existing rehabilitation setting in New Zealand? How satisfied are adolescents with TBI and their parents/caregivers with TOPS? What kind of treatment effects are observed compared to usual care?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69310 0
Dr Kelly Jones
Address 69310 0
National Institute for Stroke and Applied Neurosciences
School of Public Health & Psychosocial studies
Auckland University of Technology
Private Bag 92006
Auckland 1142
Country 69310 0
New Zealand
Phone 69310 0
+64 7 838 4257
Fax 69310 0
Email 69310 0
[email protected]
Contact person for public queries
Name 69311 0
Dr Kelly Jones
Address 69311 0
National Institute for Stroke and Applied Neurosciences
School of Public Health & Psychosocial studies
Auckland University of Technology
Private Bag 92006
Auckland 1142
Country 69311 0
New Zealand
Phone 69311 0
+64 7 838 4257
Fax 69311 0
Email 69311 0
[email protected]
Contact person for scientific queries
Name 69312 0
Dr Kelly Jones
Address 69312 0
National Institute for Stroke and Applied Neurosciences
School of Public Health & Psychosocial studies
Auckland University of Technology
Private Bag 92006
Auckland 1142
Country 69312 0
New Zealand
Phone 69312 0
+64 7 838 4257
Fax 69312 0
Email 69312 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data sharing processes not in place at time of study commencement on 2013.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.