Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000785707
Ethics application status
Approved
Date submitted
20/05/2022
Date registered
2/06/2022
Date last updated
2/06/2022
Date data sharing statement initially provided
2/06/2022
Date results information initially provided
2/06/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is telephone delivery of the Strength 2 Strength (S2S) group program a feasible way to build resilience among family members supporting relatives with Acquired Brain Injury (ABI)?
Scientific title
Building resilience among family members supporting relatives with Acquired Brain Injury in rural New South Wales: Testing the feasibility of a phone-based delivery of the Strength 2 Strength program
Secondary ID [1] 307150 0
None
Universal Trial Number (UTN)
Trial acronym
S2S Phone
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Acquired Brain Injury (ABI) 326347 0
Traumatic Brain Injury (TBI) 326348 0
Condition category
Condition code
Neurological 323652 323652 0 0
Other neurological disorders
Stroke 323653 323653 0 0
Haemorrhagic
Stroke 323654 323654 0 0
Ischaemic
Injuries and Accidents 323655 323655 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief Name: S2S Phone-Based Feasibility and Pilot Study
The S2S program was created as a ten hour group-based psycho-educational program to build resilience among family members supporting relatives with TBI. An abbreviated five hour version was developed to make it more accessible (less time demand and ease of forming a group) as a single workshop or a 5 session telehealth intervention but the telehealth abbreviated program has rarely been used.
Both the full and abbreviated S2S programs use a manual with structured content and format for each of the 5 sessions that comprise the program. There are standard information handouts and worksheets for use in each session and these are provided to the group participants before the commencement of the program. Group facilitators are trained to understand the premise of the program and its delivery using the manual. The manual's title is: Strength2Strength. Building Family Resilience after Traumatic Injury. A Psycho-educational Program.
The psycho-educational program aims to build resilience through providing information, emotional support and skills acquisition. The five sessions within the group program are entitled:
1. Telling Your Story – sharing your experience to date;
2. Active Participation – learning strategies to feel less overwhelmed and manage life;
3. Staying on Top – identifying strengths used to adapt to life challenges;
4. Regaining some Balance – exploring strategies to look after yourself;
5. Staying Connected – with family, friends and community supports.

The intervention study aimed to test the (i) feasibility, (ii) outcomes, and (iii) acceptability of a phone-based delivery of the abbreviated five-hour version of the S2S group program among family members of individuals with ABI living in rural New South Wales (NSW). A quasi-experimental single group design was employed.

Three separate telephone groups were conducted between 2016 and 2018 and were delivered to family members of adult clients of the Mid-Western Brain Injury Rehabilitation Program (MWBIRP). This service operates from Bathurst Health Service and provides a multidisciplinary outreach community rehabilitation program to adults of working age living within a defined geographic area. It takes three hours to drive to the furthest town serviced from Bathurst. The MWBIRP is one service within the NSW Brain Injury Rehabilitation Program – a service network covering the majority of NSW.

The S2S Phone intervention was delivered by a senior social worker and clinical psychologist with high level group facilitation skills and with experience in brain injury rehabilitation and working with families.
The two facilitators delivered the program in the following way:
a) all course resource material was sent to participants (either email or regular mail) before the commencement of the program. This material included content handouts and exercise tools, worksheets for specific session content, a dvd showing guest speaker in session 2,
b) the 2 facilitators met with all group participants using NSW Health group teleconferencing facilities accessible at no cost to the participants and available through landlines and mobile telephones. This created a group setting. The group met at a planned time once a week for 1.25 hours for 5 weeks.

Monitoring of adherence to the intervention occurred by:
a) facilitators keeping an attendance list for each session;
b) if any participant missed a session, then before the next week's session one of the facilitators spoke with the participant about the material covered during the missed session, the contributions made by other participants during the session and explored the participant's views about the discussion topic;
c) data was collected from each participant concerning the process and content of each session. This was done by means of a Session Satisfaction Sheet which participants were asked to complete at the end of each weekly session. This sought ratings about relevance of the content, clarity of the material, whether content covered the aims and objectives, whether they liked the mix of activities and discussion, whether the session timing was suitable, which activity they found useful, what they enjoyed the most in the session.
c) at the beginning of each session facilitators summarised the previous week's group experience and confirmed whether participants had prepared for the session and whether they had practised any particular skill previously introduced.
Intervention code [1] 323602 0
Rehabilitation
Intervention code [2] 323603 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331394 0
A change in resilience experience and levels as rated by family members.

Validated measures used to assess resilience and its change over time:
*Connor-Davidson Resilience Scale
*Resilience Scale (Wagnild and Young)

Timepoint [1] 331394 0
Baseline (pre-intervention),
After completion of S2S Phone (within two weeks of end date of intervention),
Three months (12 to 13 weeks) following completion of S2S Phone
Secondary outcome [1] 409724 0
Change in participant levels of emotional distress as rated using the validated Depression Anxiety and Stress Scale-21 (DASS-21)
Timepoint [1] 409724 0
Baseline (pre-intervention),
After completion of S2S Phone (within two weeks of end date of intervention),
Three months (12 to 13 weeks) following completion of S2S Phone
Secondary outcome [2] 409725 0
Change in participant rating of emotional wellbeing using the validated Positive and Negative Affect Scale (PANAS)
Timepoint [2] 409725 0
Baseline (pre-intervention),
After completion of S2S Phone (within two weeks of end date of intervention),
Three months (12 to 13 weeks) following completion of S2S Phone
Secondary outcome [3] 409726 0
Change in the carer’s ratings of the helpfulness of a list of management strategies in caring for their relative and maintaining personal capacity to provide care using the validated Carer Assessment of Managing Index (CAMI).

Higher scores represent higher ratings of the helpfulness of the strategies and greater use of strategies
Timepoint [3] 409726 0
Baseline (pre-intervention),
After completion of S2S Phone (within two weeks of end date of intervention),
Three months (12 to 13 weeks) following completion of S2S Phone
Secondary outcome [4] 409727 0
Change in the participant’s rating of the level of burden experienced when caring for a person with a neurological impairment as rated using the validated Caregiver Burden Scale (CBS).

Higher scores indicate higher burden
Timepoint [4] 409727 0
Baseline (pre-intervention),
After completion of S2S Phone (within two weeks of end date of intervention),
Three months (12 to 13 weeks) following completion of S2S Phone

Eligibility
Key inclusion criteria
* Aged 18 years or older
* Primary person providing support to person with severe acquired brain injury (ABI) aged between 18 and 65 years (severe ABI defined as TBI with duration of Post Traumatic Amnesia > 7 days or severe non-traumatic brain injury)
* Have no severe co-morbid psychiatric condition
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Poor English fluency as the study involved participating in an English-language program and answering a battery of questionnaires that were only available in English
* Severe psychiatric condition

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative outcome data were entered into SPSS V.26. Descriptives were generated for all variables. Outcome variables were scored and inspected for normality. Paired t-tests were employed to evaluate pairwise relationships among the three time points. Given the small sample size, the significance level was set at p<.10. (Schumm et al., 2013)

Schumm, W. R., Pratt, K. K., Hartenstein, J. L., Jenkins, B. A., & Johnson, G. A. (2013). Determining statistical significance (alpha) and reporting statistical trends: Controversies, issues, and facts. Comprehensive Psychology, 2, 10.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/08/2016
Date of last participant enrolment
Anticipated
Actual
12/04/2018
Date of last data collection
Anticipated
Actual
16/07/2018
Sample size
Target
10
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22388 0
Bathurst Base Hospital - Bathurst
Recruitment postcode(s) [1] 37552 0
2795 - Bathurst

Funding & Sponsors
Funding source category [1] 311453 0
Hospital
Name [1] 311453 0
Mid Western Brain Injury Rehabilitation Program
Country [1] 311453 0
Australia
Primary sponsor type
Hospital
Name
Mid Western Brain Injury Rehabilitation Program
Address
Mid Western Brain Injury Rehabilitation Program,
Ground Floor Heritage Building,
Bathurst Hospital,
Howick Street,
Bathurst, NSW, 2795
Country
Australia
Secondary sponsor category [1] 312849 0
None
Name [1] 312849 0
Address [1] 312849 0
Country [1] 312849 0
Other collaborator category [1] 282313 0
Charities/Societies/Foundations
Name [1] 282313 0
Brain Injury Rehabilitation Research Group,
Address [1] 282313 0
Ingham Institute for Applied Medical Research,
1 Campbell Street,
Liverpool , NSW, 2170
Country [1] 282313 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310925 0
Greater Western Human Research Ethics Committee – Incorporating the Western NSW and Far West Local Health Districts,
Ethics committee address [1] 310925 0
Greater Western Human Research Ethics Committee – Incorporating the Western NSW and Far West Local Health Districts,
PO Box 143,
Bathurst NSW 2795
(Street address: Unit 2, 39 Hampden Park Road, Bathurst )
Ethics committee country [1] 310925 0
Australia
Date submitted for ethics approval [1] 310925 0
08/02/2016
Approval date [1] 310925 0
10/04/2016
Ethics approval number [1] 310925 0
GWAHS 2016-11 & HREC/16/GWAHS/14; REGIS Reference 2019/ETH04025

Summary
Brief summary
Strength 2 Strength is a group program developed and published in 2012. The program was designed to enhance the resilience of family members supporting a person who has acquired a brain injury. The group program provides family members with the chance to speak with others in a similar situation and share experiences. It also provides information on the ways of managing the changes and challenges after a family member sustains a brain injury and gives information about services and supports available in the community. People who participated in the face to face group have found it very useful and effective when run in a number of settings in metropolitan areas of NSW. It can be difficult to run the face to face group program in rural areas where people living with acquired brain injuries and the family members who assist them, are scattered over a wide area and struggle to consistently meet once a week for five weeks. As a result, a shortened version of the group program was developed in 2012 but its effectiveness was not established. The shortened program is facilitated by two people and the guidelines suggest that no more than 4 family participants be involved in each group if telephone conferencing is used. This study is designed to investigate the effectiveness of this shortened program which runs for about an hour once a w eek using discussion tools that have been sent to participants before each session. A number of questionnaires (administered pre- post and follow-up) will be used to investigate the outcomes (primary, secondary) for the participant family members.
Trial website
Nil
Trial related presentations / publications
Public notes
Recruitment came from a defined geographic area within Western NSW Local Health District (service area of Mid Western Brain Injury Rehabilitation Program which is based at Bathurst Base Hospital).
The postcodes of the recruited participants were: 2795, 2798, 2800, 2804, 2871

Contacts
Principal investigator
Name 119370 0
Ms Denise Young
Address 119370 0
c/- Mid Western Brain Injury Rehabilitation Program,
Ground Floor Heritage Building
Bathurst Hospital,
Howick Street,
Bathurst NSW 2795
Country 119370 0
Australia
Phone 119370 0
+61 400 271 899
Fax 119370 0
Email 119370 0
denisegyoung@bigpond.com
Contact person for public queries
Name 119371 0
Ms Jerre Weaver
Address 119371 0
Jerre Weaver, Clinical Psychologist,
Mid Western Brain Injury Rehabilitation Program,
Ground Floor Heritage Building,
Bathurst Hospital,
Howick Street,
Bathurst NSW 2795
Country 119371 0
Australia
Phone 119371 0
+61 2 6330 5108
Fax 119371 0
Email 119371 0
jerre.weaver@health.nsw.gov.au
Contact person for scientific queries
Name 119372 0
A/Prof Grahame Simpson
Address 119372 0
Brain Injury Rehabilitation Research Group,
Ingham Institute for Applied Medical Research,
1 Campbell St,
Liverpool 2170 NSW
Country 119372 0
Australia
Phone 119372 0
+61 2 8738 5495
Fax 119372 0
Email 119372 0
grahame.simpson@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Permission to deposit participant data in a public repository was not sought at the time of consenting.


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.