Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001338853
Ethics application status
Approved
Date submitted
26/07/2021
Date registered
6/10/2021
Date last updated
25/01/2023
Date data sharing statement initially provided
6/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of family and school partnership program impacts on child education and mental health
Scientific title
A randomised school trial to evaluate family and school partnership program impacts on child education and mental health
Secondary ID [1] 301278 0
Nil
Universal Trial Number (UTN)
U1111-1252-0105
Trial acronym
Nil
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
mental health 317456 0
Condition category
Condition code
Mental Health 315556 315556 0 0
Depression
Public Health 315557 315557 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A primary school-based program delivered to families (parents & children) to improve communication, relationships and parenting. This will consist of two intervention components:

1) Strengthening Family Connections (SFC) Program: The SFC is a manualised program adapted from the original Strengthening Families Program (SFP) to align with the Australian school term. The SFC program provides family skills training in communication techniques and family behaviours to enhance family relationships and healthy child development. The SFC will be delivered by Barwon Child Youth and Family (BCYF) as a routine program in 7 primary schools in the Geelong region. BCYF will recruit parents with children aged 8-12 years using their routine service procedures. The SFC will be delivered face-to-face or online by two trained facilitators in eight 2-hour sessions with groups of 3 to 7 families run over 8 weeks. In the first hour of each session families are separated into two groups, one comprised of children the other of parents. Facilitators of each group overview skills to be covered in the session. These skills are then practiced in the second hour, when family groups are bought together to complete practical tasks involved in sharing a meal. Topics covered across the 8 weeks for parents include: setting goals, self-care, communication and relationships, setting limits, problem-solving, and family management to prevent drug and alcohol use. For children, topics include: goals and dreams, communication, identifying and coping with feelings, seeking support, problem-solving, handling change, and psychoeducation on drugs, alcohol and healthy lifestyle choices. Adherence is monitored by supervisors checking activities against program content lists.

(2). Parenting Resilient Kids (PaRK) is an individually-tailored online parenting intervention for the prevention of depression and anxiety problems suitable for primary school age children. PaRK comprises two components: a) a personally-tailored feedback report highlighting parenting strengths and providing specific parenting strategies for further improvement; b) up to 12 interactive online modules are offered with the feedback report highlighting specific strategies and modules tailored to identified areas for parent improvement. The interactive modules use a training strategy involving online text followed by comprehension testing questions and feedback. The content of the interactive modules includes strategies to: improve parent-child relationships, family rules and consequences, conflict management, healthy lifestyle behaviours, coping with stress, managing anxiety, and help seeking. Adherence to the PaRK intervention is monitored by analysis of online utilisation of the interactive content and parent self-report of whether they have read and acted upon their feedback reports. Parents will be offered PaRK at the same time as SFC.
Intervention code [1] 317586 0
Prevention
Comparator / control treatment
Families (parents and children) following normal routine practices in 7 matched primary schools not invited to participate in Strengthening Families Connections (SFC) or Parenting Resilient Kids (PaRK).
Control group
Active

Outcomes
Primary outcome [1] 323801 0
Parent reported student academic achievement in Grade 3 to 5 assessed in an online survey with 14-items (e.g., this year … how it has been for your child: understanding the work in class, getting assignments and homework done, reading) adapted from the Australian Temperament Project Child School Achievement Scale
Timepoint [1] 323801 0
Baseline, post-program and then 3-months and 12-months (primary endpoint) after the intervention has been delivered.
Primary outcome [2] 328391 0
Parent school engagement assessed in an online parent-report survey with 8-items (e.g., have you - talked to parents, attended a school event, volunteered … in class) adapted from the Longitudinal Study of Australian Children, School Engagement Scale
Timepoint [2] 328391 0
Baseline, post-program and then 3-months and 12-months (primary endpoint) after the intervention has been delivered.
Secondary outcome [1] 382936 0
Academic achievement as assessed by school-wide NAPLAN (National Assessment Program – Literacy and Numeracy tests)
Timepoint [1] 382936 0
2016, 2017, 2018, 2019, 2022, 2023 to assess trends from before versus after the intervention has been delivered.
Secondary outcome [2] 383024 0
School-wide AEDC (Australian Early Development Census) scores
Timepoint [2] 383024 0
2009, 2012, 2015, 2018, 2021, 2024 to assess trends from before versus after the intervention has been delivered.
Secondary outcome [3] 383025 0
Parent ratings of child internalising behaviour problems assessed using an online version of the Strengths and Difficulties Questionnaire
Timepoint [3] 383025 0
Baseline, post-program and then 3-months and 12-months after the intervention has been delivered.
Secondary outcome [4] 383026 0
Parent ratings of child adherence to nutrition guidelines based on days per week that children: drink mainly water with no sugar sweetened drinks; eat four or more serves of vegetables/legumes/beans; and two or more serves of fruit
Timepoint [4] 383026 0
Baseline, post-program and then 3-months and 12-months after the intervention has been delivered.
Secondary outcome [5] 383027 0
Parent ratings of child adherence to physical activity guidelines based on days per week that children: walk or ride to and from school or for fun; spend at least 60 minutes in moderate to vigorous intensity physical activity; spend no more than two hours using electronic media for entertainment (e.g. television, seated electronic games and computer use).
Timepoint [5] 383027 0
Baseline, post-program and then 3-months and 12-months after the intervention has been delivered.
Secondary outcome [6] 398878 0
Rates of parent recruitment in a Longitudinal survey calculated from the number entering the survey divided by the parent population within each school classroom.
Timepoint [6] 398878 0
Parent entry into the survey at the conclusion of the study period.

Eligibility
Key inclusion criteria
Parents/primary carers/guardians of children in either grade 2 or 4 and aged between 8-12 years.
Minimum age
8 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Schools outside the target geographic areas and families with children who attend schools not participating in the trial.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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
For the primary outcomes (parent report of child academic achievement and school engagement), and secondary outcomes (school wide assessment of academic achievement; child internalising behaviour problems; adherence to nutrition guidelines; and adherence to physical activity guidelines), ANCOVA will be used. ANCOVA will be used to predict the parent rating scores of child behaviour at follow-up. The hypothesis would be confirmed if there is a significant Time trend for improvement in the intervention schools, compared to the control schools. Analyses will adjust for predictors of child behaviour including, child gender, family demographics and disadvantage, child baseline externalising, nutrition behaviour, physical activity, school adjustment and risk factors

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/10/2021
Actual
11/10/2021
Date of last participant enrolment
Anticipated
9/10/2023
Actual
Date of last data collection
Anticipated
20/12/2024
Actual
Sample size
Target
2240
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 305724 0
Charities/Societies/Foundations
Name [1] 305724 0
Ian Potter Foundation
Country [1] 305724 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway, Burwood, 3125, Victoria
Country
Australia
Secondary sponsor category [1] 306186 0
University
Name [1] 306186 0
Monash University
Address [1] 306186 0
Wellington Rd, Clayton VIC 3800
Country [1] 306186 0
Australia
Secondary sponsor category [2] 306187 0
University
Name [2] 306187 0
University of Melbourne
Address [2] 306187 0
Grattan Street, Parkville, VIC 3010.
Country [2] 306187 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305999 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 305999 0
Ethics committee country [1] 305999 0
Australia
Date submitted for ethics approval [1] 305999 0
01/06/2020
Approval date [1] 305999 0
16/09/2020
Ethics approval number [1] 305999 0
2020 - 168

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

Contacts
Principal investigator
Name 102366 0
Prof John Toumbourou
Address 102366 0
School of Psychology,
Geelong Waterfront Campus,
Deakin University, Geelong, Victoria, 3220
Country 102366 0
Australia
Phone 102366 0
+61 400 502 938
Fax 102366 0
Email 102366 0
[email protected]
Contact person for public queries
Name 102367 0
Elizabeth Clancy
Address 102367 0
School of Psychology
Deakin University
221 Burwood Highway, Burwood, Victoria, 3125
Country 102367 0
Australia
Phone 102367 0
+61 416274065
Fax 102367 0
Email 102367 0
[email protected]
Contact person for scientific queries
Name 102368 0
John Toumbourou
Address 102368 0
School of Psychology,
Geelong Waterfront Campus,
Deakin University, Geelong, Victoria, 3220
Country 102368 0
Australia
Phone 102368 0
+61 400 502 938
Fax 102368 0
Email 102368 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 collected will be anonymous and as such individual data will not be able to be shared.


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.