ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

Nil

Universal Trial Number (UTN)

U1111-1305-0305

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

autism

Condition category

Condition code

Mental Health

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]

Prevention

Comparator / control treatment

None

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Feasibility

Timepoint [1]

T1 (baseline), T2 (post-completion of the 8-week program), T3 (3-month follow up post-completion of the program)

Primary outcome [2]

Acceptability

Timepoint [2]

T1 (baseline), T2 (post-completion of the 8-week program), T3 (3-month follow up post-completion of the program)

Secondary outcome [1]

Parental expressed emotion and view of autism

Timepoint [1]

T1 (baseline), T2 (post-completion of the 8-week program), T3 (3-month follow up post-completion of the program)

Secondary outcome [2]

Child Quality of Life

Timepoint [2]

T1 (baseline), T2 (post-completion of the 8-week program), T3 (3-month follow up post-completion of the program)

Secondary outcome [3]

Family Quality of Life

Timepoint [3]

T1 (baseline), T2 (post-completion of the 8-week program), T3 (3-month follow up post-completion of the program)

Secondary outcome [4]

Child supports and services accessed

Timepoint [4]

T1 (baseline), T3 (3-month follow up post-completion of the program)

Secondary outcome [5]

Parental wellbeing

Timepoint [5]

T1 (baseline), T2 (post-completion of the 8-week program), T3 (3-month follow up post-completion of the program)

Secondary outcome [6]

Parent impression of change

Timepoint [6]

T2 (post-completion of the 8-week program), TT3 (3-month follow up post-completion of the program)

Secondary outcome [7]

Child quality of life

Timepoint [7]

T1 (baseline), T2 (post-completion of the 8-week program), T3 (3-month follow up post-completion of the program)

Secondary outcome [8]

Child quality of life

Timepoint [8]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Department of Health and Aged Care - Medical Research Future Fund (MRFF)

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

Griffith University

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Griffith University Human Research Ethics Committee

Ethics committee address [1]

https://www.griffith.edu.au/research/research-services/research-ethics-integrity/human/human-research-ethics-committee

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/11/2023

Approval date [1]

22/01/2024

Ethics approval number [1]

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

Prof Dawn Adams

Address

Autism Centre of Excellence, Griffith University, Mount Gravatt Campus M10 5.24, 176 Messines Ridge Rd, Mount Gravatt QLD 4122

Country

Australia

Phone

+61 735355854

Fax

dawn.adams@griffith.edu.au

Contact person for public queries

Name

Dawn Adams

Address

Autism Centre of Excellence, Griffith University, Mount Gravatt Campus M10 5.24, 176 Messines Ridge Rd, Mount Gravatt QLD 4122

Country

Australia

Phone

+61 735355854

Fax

dawn.adams@griffith.edu.au

Contact person for scientific queries

Name

Dawn Adams

Address

Autism Centre of Excellence, Griffith University, Mount Gravatt Campus M10 5.24, 176 Messines Ridge Rd, Mount Gravatt QLD 4122

Country

Australia

Phone

+61 735355854

Fax

dawn.adams@griffith.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
21788	Study protocol			dawn.adams@griffith.edu.au	Currently under review
21789	Informed 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.

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