Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000350527
Ethics application status
Approved
Date submitted
3/03/2024
Date registered
27/03/2024
Date last updated
27/03/2024
Date data sharing statement initially provided
27/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Bloom: Evaluating the ability of a co-produced parent group to nurture young autistic children to flourish and thrive
Scientific title
A feasibility and acceptability trial of Bloom; a co-produced parent group to focussing on quality of life and wellbeing of young autistic children.
Secondary ID [1] 311652 0
Nil
Universal Trial Number (UTN)
U1111-1305-0305
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
autism 333110 0
Condition category
Condition code
Mental Health 329794 329794 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name: Bloom
The content of Bloom was primarily informed by community perspectives and experiences, with additional underpinning content coming from the extant literature base reporting on factors that influence or impact Quality of Life in autistic children. The community perspectives and experiences were gained through over 70 hours of interviews with autistic adults and parents of autistic children. We also drew upon survey and interview data from 22 young autistic people who were asked about the factors that impact or influence their wellbeing. In conjunction with representatives from autistic-led and non-autistic led community organisations, this content was analysed to inform the main topics in Bloom. The paper describing these findings is being co-authored by the research team as well as representatives from autistic-led and non-autistic led community organisations.

The intervention content and materials were drafted by the research team, which includes autistic and neurodivergent researchers and clinicians, neurotypical researchers and clinicians and researchers who are parents of autistic children. Representatives from autistic-led and non-autistic led community organisations were invited to review and provide feedback on multiple versions of the draft materials for each session as well as the final version of all materials for each session. Representatives from autistic-led and non-autistic led community organisations also provided the recommended resources which are shared with parents at the end of each session. They were able to provide feedback in any way that suited them (e.g. written, verbal) and were provided two weeks to review documents.

Bloom was piloted with four parents of autistic children and their feedback sought after each session. This content was used to further refine the intervention materials and prepare them for the trial.

Bloom consists of eight, two-hour sessions, delivered weekly. Up to 10 parents will be invited to attend each session. Groups will be delivered online or face-to-face. Parents are given a manual and workbook each week with includes a written summary of content discussed and places to complete the exercises (which can be typed into or printed off).

The content of each session is manualised. Each session will be co-facilitated by a therapist (an allied health professional with strong knowledge of autism and training in Bloom) and an autistic co-facilitator (an Autistic adult with training in Bloom, and ideally some experience in supporting parents or advocacy), referred to as an Autistic Guide. Sessions consist of information presented by the faciltator or autistic guide, personal narratives from the autistic guide as illustrative real-life examples of the content covered (e.g. examples of the guide's deep interests, examples of ways that the guide has made strong connections with others), reflective exercises for parents (both independent and group based) and group discussions based on personal experience. No homework is set but parents are directed to "extra inspirational" content if they wish to complete additional exercises between sessions.

The facilitator in each group has the role of taking attendance for each group, and following up with any parents who were not able to attend. Each session will be recorded and this will be used to check for fidelity.
Intervention code [1] 328113 0
Prevention
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337571 0
Feasibility
Timepoint [1] 337571 0
T1 (baseline), T2 (post-completion of the 8-week program), T3 (3-month follow up post-completion of the program)
Primary outcome [2] 337572 0
Acceptability
Timepoint [2] 337572 0
T1 (baseline), T2 (post-completion of the 8-week program), T3 (3-month follow up post-completion of the program)
Secondary outcome [1] 432350 0
Parental expressed emotion and view of autism
Timepoint [1] 432350 0
T1 (baseline), T2 (post-completion of the 8-week program), T3 (3-month follow up post-completion of the program)
Secondary outcome [2] 432351 0
Child Quality of Life
Timepoint [2] 432351 0
T1 (baseline), T2 (post-completion of the 8-week program), T3 (3-month follow up post-completion of the program)
Secondary outcome [3] 432352 0
Family Quality of Life
Timepoint [3] 432352 0
T1 (baseline), T2 (post-completion of the 8-week program), T3 (3-month follow up post-completion of the program)
Secondary outcome [4] 432353 0
Child supports and services accessed
Timepoint [4] 432353 0
T1 (baseline), T3 (3-month follow up post-completion of the program)
Secondary outcome [5] 432354 0
Parental wellbeing
Timepoint [5] 432354 0
T1 (baseline), T2 (post-completion of the 8-week program), T3 (3-month follow up post-completion of the program)
Secondary outcome [6] 432355 0
Parent impression of change
Timepoint [6] 432355 0
T2 (post-completion of the 8-week program), TT3 (3-month follow up post-completion of the program)
Secondary outcome [7] 432914 0
Child quality of life
Timepoint [7] 432914 0
T1 (baseline), T2 (post-completion of the 8-week program), T3 (3-month follow up post-completion of the program)
Secondary outcome [8] 432915 0
Child quality of life
Timepoint [8] 432915 0
T1 (baseline), T2 (post-completion of the 8-week program), T3 (3-month follow up post-completion of the program)

Eligibility
Key inclusion criteria
Parents of autistic children will be eligible to participate if:
- their autistic child, aged 3-8 years, lives with them for 50% of more of the time and the family live in Australia.
- the parent is able to attend the parent group sessions (online or in-person) and to have sufficient English language skills to consent and access group content.
- they can confirm their autistic child's diagnosis through a copy of their diagnostic report or through completing an autism screener questionnaire
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Parents who report experiencing significant mental health challenges which may impact their ability to engage in the group or the trial

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



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
N/A for feasibility trial

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/03/2024
Actual
Date of last participant enrolment
Anticipated
1/11/2024
Actual
Date of last data collection
Anticipated
25/04/2025
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315979 0
Government body
Name [1] 315979 0
Department of Health and Aged Care - Medical Research Future Fund (MRFF)
Country [1] 315979 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 318121 0
None
Name [1] 318121 0
Address [1] 318121 0
Country [1] 318121 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314800 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 314800 0
https://www.griffith.edu.au/research/research-services/research-ethics-integrity/human/human-research-ethics-committee
Ethics committee country [1] 314800 0
Australia
Date submitted for ethics approval [1] 314800 0
15/11/2023
Approval date [1] 314800 0
22/01/2024
Ethics approval number [1] 314800 0
2023/934

Summary
Brief summary
This is a feasibility and acceptability study of a parent-coaching group, Bloom, which has been co-designed and co-produced between researchers and community organisations. The study aims to recruit parents of 80 autistic children aged 3-8 years through community organisations and social media networks. The primary outcomes will look at how acceptable the group is to parents, and how feasible it is to run a bigger definitive trial of this group in the future.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132778 0
Prof Dawn Adams
Address 132778 0
Autism Centre of Excellence, Griffith University, Mount Gravatt Campus M10 5.24, 176 Messines Ridge Rd, Mount Gravatt QLD 4122
Country 132778 0
Australia
Phone 132778 0
+61 735355854
Fax 132778 0
Email 132778 0
dawn.adams@griffith.edu.au
Contact person for public queries
Name 132779 0
Dawn Adams
Address 132779 0
Autism Centre of Excellence, Griffith University, Mount Gravatt Campus M10 5.24, 176 Messines Ridge Rd, Mount Gravatt QLD 4122
Country 132779 0
Australia
Phone 132779 0
+61 735355854
Fax 132779 0
Email 132779 0
dawn.adams@griffith.edu.au
Contact person for scientific queries
Name 132780 0
Dawn Adams
Address 132780 0
Autism Centre of Excellence, Griffith University, Mount Gravatt Campus M10 5.24, 176 Messines Ridge Rd, Mount Gravatt QLD 4122
Country 132780 0
Australia
Phone 132780 0
+61 735355854
Fax 132780 0
Email 132780 0
dawn.adams@griffith.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We have not resolved a plan yet. We are currently discussing this with our community partner organisations (who are co-producing this study) to work out what can be stored, where and when.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21788Study protocol  dawn.adams@griffith.edu.au Currently under review
21789Informed consent form  dawn.adams@griffith.edu.au



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.