Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000980538
Ethics application status
Approved
Date submitted
29/07/2024
Date registered
12/08/2024
Date last updated
12/08/2024
Date data sharing statement initially provided
12/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
CONNECT: A Support Program for Families Following a Developmental Assessment
Scientific title
CONNECT - A Brief, Solution-Focused Support Program for Families Following a Developmental Assessment: A Randomised Pilot and Feasibility Trial
Secondary ID [1] 312634 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurodevelopmental Differences 334592 0
Neurodevelopmental Disabilities 334593 0
Condition category
Condition code
Mental Health 331184 331184 0 0
Autistic spectrum disorders
Mental Health 331185 331185 0 0
Learning disabilities
Mental Health 331187 331187 0 0
Other mental health disorders
Public Health 331245 331245 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CONNECT follows a Solution-Focused Brief Therapy (SFBT) framework.

SFBT is short-term and evidence-based. It focusses on the solutions to the problem(s) experienced by the families, rather than the problem(s) themselves, by empowering and encouraging caregivers to achieve their goals.

Participants will be randomised into two arms: Arm 1 - Intervention (i.e., accesses CONNECT) and Arm 2 - Care as Usual (i.e., no access to CONNECT). Participants across both arms of the study will have a baseline session with the study psychologists to discuss the report and recommendations received after their child's developmental assessment. This will occur prior to accessing the intervention (Arm 1) or continuing their care as usual (Arm 2).

The CONNECT intervention for participants allocated to Arm 1 is described in this following section.

Participants who have been randomised into Arm 1 will receive up to 4 x 45-60 minute, one-on-one sessions with one of the study psychologists. The sessions will be organised 1-3 weeks apart over a 4 month period as appropriate for the participants. As part of these sessions, the participants and psychologists will identify up to three goals that are related to caregiver and/or family functioning following their child's recent neurodevelopmental diagnosis. Then, the psychologist will provide participants with support within a SFBT framework that is tailored to the specific goals that they have identified. CONNECT is not a manualised intervention; instead, it is client-led.

The techniques used within this framework may draw from other contemporary therapeutic modalities, such as Motivational Interviewing and Acceptance and Commitment Therapy. These sessions may be held in-person at the university clinics, over the phone, or via teleconferencing depending on the participants' preferences. These sessions will be largely talk-therapy based with additional handouts and homework tasks as appropriate to the participant's circumstances.

All sessions will be audio recorded to allow for an evaluation of the CONNECT psychologist's fidelity and adherence to the SFBT framework. Only a randomly selected subset of the audio recordings will be used for the fidelity evaluation. This will be completed by independent research team members through the development of a shared coding protocol, based on a checklist of SFBT principles.
Intervention code [1] 329152 0
Rehabilitation
Intervention code [2] 329153 0
Treatment: Other
Intervention code [3] 329154 0
Behaviour
Comparator / control treatment
Arm 2 - Care as Usual participants will continue with their standard care processes as advised by their medical treating team. There are no limits on what this can include, except that they will not be accessing the CONNECT intervention. Examples of the standard care processes may include: applications for, or accessing, the National Disability Insurance Scheme (NDIS); privately accessing allied health services including psychology, occupational therapy, speech therapy, or physiotherapy; attending local parent and/or family support groups run by healthcare services for families with children who have similar neurodevelopmental diagnoses, etc.
Control group
Active

Outcomes
Primary outcome [1] 338947 0
Intervention Feasibility
Timepoint [1] 338947 0
All measures except for the Post-Intervention Questionnaire and phone call interview will be administered at baseline and approximately 4-months post-randomisation. The Post-Intervention Questionnaire and phone call interview will be administered at approximately 4-months post-randomisation.

The other study metrics will be obtained at the conclusion of data collection.
Secondary outcome [1] 437998 0
Family quality of life
Timepoint [1] 437998 0
Baseline and approximately 4-months post-randomisation
Secondary outcome [2] 437999 0
Caregiver empowerment and self-efficacy
Timepoint [2] 437999 0
Baseline and approximately 4-months post-randomisation
Secondary outcome [3] 438000 0
Caregiver success in implementing recommendations from developmental assessment report
Timepoint [3] 438000 0
Approximately 4-months post-randomisation

Eligibility
Key inclusion criteria
Participants will include caregivers (i.e., anyone who has primary parenting responsibilities, such as birth parents, grandparents, uncles, aunties, foster parents, adoptive parents, etc.) of a child under 18 years of age who has received a neurodevelopmental diagnosis in the last 12 months.

Additional inclusion criteria are:
(1) Participants must have sufficient levels of English to complete the questionnaires and intervention sessions, OR, be able to nominate someone who can attend with them who has sufficient levels of English
(2) The young person is not already engaged in intervention services for this new neurodevelopmental diagnosis. Engagement with existing intervention services for other diagnoses/needs is acceptable.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not applicable.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be determined by an independent member of the research team who will not be involved in recruitment or data collection. This team member will upload the allocations to the study's REDCap database and lock the allocations, therefore concealing the allocation list to all other team members.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence will be generated by a computerised, random number sequence generator, run by the abovementioned research team member.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis will follow a mixed-methods approach.

Quantitative between-groups and within-participant, repeated measures analyses will be undertaken on the secondary outcome measures. Descriptive statistics will be reported for the primary outcome measure questionnaire responses.

Qualitative analysis of post-intervention interview/phone call conversations will allow for the identification of key themes related to the barriers and enablers of implementing recommendations, caregiver wellbeing, and family functioning. Additional feedback regarding the CONNECT intervention specific only to Arm 1 - Intervention participants will also be gathered, analysed, and reported.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/08/2024
Actual
Date of last participant enrolment
Anticipated
31/03/2025
Actual
Date of last data collection
Anticipated
28/07/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26874 0
Monash Children’s Hospital - Clayton
Recruitment postcode(s) [1] 42936 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 317069 0
Charities/Societies/Foundations
Name [1] 317069 0
McNally Family Foundation
Country [1] 317069 0
Australia
Primary sponsor type
Individual
Name
Professor Katrina Williams - Department of Paediatrics, Monash University
Address
Country
Australia
Secondary sponsor category [1] 319321 0
None
Name [1] 319321 0
Address [1] 319321 0
Country [1] 319321 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315818 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 315818 0
Ethics committee country [1] 315818 0
Australia
Date submitted for ethics approval [1] 315818 0
24/06/2024
Approval date [1] 315818 0
26/06/2024
Ethics approval number [1] 315818 0
Ethics committee name [2] 315820 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 315820 0
Ethics committee country [2] 315820 0
Australia
Date submitted for ethics approval [2] 315820 0
26/06/2024
Approval date [2] 315820 0
27/06/2024
Ethics approval number [2] 315820 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135902 0
Dr Alexandra Ure
Address 135902 0
Department of Psychology & Specialist Services, Monash Health, 246 Clayton Road, Clayton VIC 3168
Country 135902 0
Australia
Phone 135902 0
+61 467 932 130
Fax 135902 0
Email 135902 0
[email protected]
Contact person for public queries
Name 135903 0
Tracey Chau
Address 135903 0
Department of Paediatrics, Monash Children's Hospital, 246 Clayton Road, Clayton VIC 3168
Country 135903 0
Australia
Phone 135903 0
+61 3 8572 3000
Fax 135903 0
Email 135903 0
[email protected]
Contact person for scientific queries
Name 135904 0
Tracey Chau
Address 135904 0
Department of Paediatrics, Monash Children's Hospital, 246 Clayton Road, Clayton VIC 3168
Country 135904 0
Australia
Phone 135904 0
+61 3 8572 3000
Fax 135904 0
Email 135904 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
Participants may be re-identifiable from the qualitative data collected even through anonymisation processes.


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.