Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001134213
Ethics application status
Approved
Date submitted
10/05/2018
Date registered
11/07/2018
Date last updated
11/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the Resilient Families Program effects on disadvantaged Grade 8 adolescents
Scientific title
Longitudinal evaluation of the Resilient Families Program effects on disadvantaged Grade 8 adolescents’ mental health, social emotional competence and family relationships
Secondary ID [1] 294844 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
family conflict 307792 0
low social emotional skills 307793 0
adolescent substance use 307794 0
mental health 307869 0
Condition category
Condition code
Mental Health 306838 306838 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 306839 306839 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A) THE INTERVENTION involves secondary schools implementing the Resilient Families intervention with Grade 8 students and their parents. Resilient Families is a structured program that includes a student social relationship curricula and parent education components and is designed to be integrated into the normal secondary school processes to enhance family-school partnerships. The delivery of the program occurs under a license system that includes implementation training and support. The five components are: (1) 10-session student curriculum. (2) Distribution to all families of a parent education book designed for the Resilient Families program titled: Preparing adolescents for success in school and life. Distributed by Australian Council for Education Research, Camberwell, Victoria. 119 pages. (3) Brief parent education groups, based on Parenting Adolescents Quiz (PAQ) where parents interact together to answer questions designed to improve understanding of current adolescent health scientific information. (4) Longer parent education groups, based on Parenting Adolescents: A Creative Experience (PACE) led by a trained facilitator with the aim to increase family management skills for raising healthy adolescents including: family rules, positive communication, problem solving and conflict resolution. Parents interact together in professionally facilitated groups to support each other to improve parenting behaviours. (5) Support to strategically review school policies and practices relating to parents and families.

B) FREQUENCY/DURATION OF THE INTERVENTION: (1) Student curriculum – 10 weekly 45-50-minute sessions. (2) Parent education book completed over approximately 10 weeks at home by parents. (3) At least one 2-hour PAQ event and (4) one PACE group advertised to all parents consisting of 8-weekly sessions each of 2 hours. (5) At least one 2-hour strategic planning session with school leaders to review family-school partnership arrangements.

C) MODE OF ADMINISTRATION: (1) Student curriculum implemented as part of usual classroom activities. (2) Parent education book is sent home by school to the registered home address. (3) PAQ and (4) PACE groups are conducted at the school. (5) Strategic planning sessions are held at the school.

D) TARGET INTENSITY: (1) Student curriculum - targeted to reach all students. (2) Parent education books - targeted to reach all parents. (3) PAQ and (4) PACE group attendance are optional for parents - invitations are sent to all parents with on average 10% volunteering to attend at least one event. (5) Strategic planning sessions target two or more school leaders.

E) WHO ADMINISTERS THE INTERVENTION? (1) Student curriculum implemented by secondary school teachers following 2-hour training. (2) Parent education book is self-administered at home by parents. (3) PAQ and (4) PACE group sessions are facilitated by trained school staff or external experts who have relevant counselling qualifications. (5) Strategic planning sessions facilitated by trained external experts.

F) STRATEGIES USED TO MONITOR ADHERENCE TO THE INTERVENTION: (1) Student curriculum fidelity measured by school teacher-completed checklist and by pre-post changes in student skills. (2) The school strategy for distributing the parent education book is recorded and fidelity is assessed through a parent survey. (3) PAQ and (4) PACE group session attendance and session coverage are recorded by facilitators. Pre-post improvements in parent skills are measured in parent surveys. (5) School strategic planning outcomes are recorded by an external expert. This information is used by each school in their continuous improvement efforts and guides the implementation of Resilient Families to new student cohorts in future years.
Intervention code [1] 301157 0
Prevention
Comparator / control treatment
Usual secondary school program. Students and parents complete surveys without their school altering their usual curricula or programs. School programs are monitored by the research team interviewing school leaders and through parent survey questions.
Control group
Active

Outcomes
Primary outcome [1] 305833 0
Mean difference on child report of Communities That Care family conflict scale (Habib et al, 2014: http://dx.doi.org/10.1007/s11121-013-0416-4)
Timepoint [1] 305833 0
Measured at baseline (Wave 1) and post-intervention (Wave 2 - 3 months after baseline).
Secondary outcome [1] 346699 0
Mean difference on child report of depressive symptoms assessed using the Short Moods and Feelings scale (Kelly et al, 2016: http://dx.doi.org/10.1007/s10964-016-0433-2)
Timepoint [1] 346699 0
Measured at baseline (Wave 1) and post-intervention (Wave 2 - 3 months after baseline).
Secondary outcome [2] 346701 0
Mean difference on child report of social emotional skills assessed using a composite score combining the scales of emotional control, positive and negative problem solving and coping reported by Short et al, (2007: Drug and Alcohol Review, 26(6), pp 625 – 634).
Timepoint [2] 346701 0
Measured at baseline (Wave 1) and post-intervention (Wave 2 - 3 months after baseline).
Secondary outcome [3] 346702 0
Mean difference on child report of school engagement assessed using a composite score combining the scales of school commitment and reward, low academic grades and school absence reported by Short et al, (2007: Drug and Alcohol Review, 26(6), pp 625 – 634)
Timepoint [3] 346702 0
Measured at baseline (Wave 1) and post-intervention (Wave 2 - 3 months after baseline).
Secondary outcome [4] 346705 0
Proportional difference on child report of alcohol use assessed with the items: Have you ever had more than just a sip or two of an alcoholic beverage (like beer, wine or liquor/spirits)? [No/ Yes]. If yes, on how many days in the past month (30 days) did you drink alcohol? [recorded as days] (Short et al, 2007: Drug and Alcohol Review, 26(6), pp 625 – 634).
Timepoint [4] 346705 0
Measured at baseline (Wave 1) and post-intervention (Wave 2 - 3 months after baseline).
Secondary outcome [5] 346971 0
Proportional difference on child report of tobacco use assessed with the items: Have you ever smoked cigarettes? [No/ Yes]. If yes, on how many days in the past month (30 days) did you smoke cigarettes? [recorded as days] (Short et al, 2007: Drug and Alcohol Review, 26(6), pp 625 – 634)
Timepoint [5] 346971 0
Measured at baseline (Wave 1) and post-intervention (Wave 2 - 3 months after baseline).
Secondary outcome [6] 346972 0
Proportional difference in child report of low cyber safety assessed based on two items “in the past three months” … “sent a nude (sexually explicit image) of yourself via your mobile phone or on another electronic communication device?” or “received a nude (sexually explicit image) via your mobile phone or on another electronic communication device?”
Timepoint [6] 346972 0
Measured at baseline (Wave 1) and post-intervention (Wave 2 - 3 months after baseline).
Secondary outcome [7] 346973 0
Mean difference on parent report of child online behaviour problems assessed on three item scale: “When my child can’t use screens, they get restless or irritable”; “Asking my child to stop using their screens often causes arguments in our family” (response options strongly disagree (1) - strongly agree (4)), “does your child have a problem with using screens (i.e., devices such as smartphones, tablets, laptops, personal computers, or interactive screens)? (response options Yes (4), No (1), Don’t know (2.5)).
Timepoint [7] 346973 0
Measured at baseline (Wave 1) and post-intervention (Wave 2 - 3 months after baseline).

Eligibility
Key inclusion criteria
All Grade 8 students in the target school classrooms in 2018. The target schools are disadvantaged based on socioeconomic indicators and academic achievement assessed using NAPLAN (National Assessment Program Literacy and. Numeracy) reading scores.
Minimum age
12 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Ability to participate in classroom program

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)
Allocation was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent statistician used a random number generator to allocate communities into control or intervention conditions. Community allocation occurred in 2006 when fourteen matched community pairs were randomly assigned into 14 control and 14 intervention communities in three states: Victoria, Western Australia and Queensland. The present study sampled the sub-set of four intervention and four control communities in Victoria that were closest to the central business district. Based on their location in these four intervention or four control communities, all secondary schools with high socioeconomic disadvantage and lower than average NAPLAN reading scores will be approached in 2018 until 14 have been recruited in each condition.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
The fourteen matched community pairs were initially selected using a random number generator from a list of all communities of 17,000 in the states of Victoria, Queensland and Western Australia stratified by socioeconomic disadvantage and urban and nonurban location in 2006. From the randomly assigned 14 control and 14 intervention communities, the present study sampled the sub-set of four intervention and four control communities in Victoria that were closest to the central business district. In the 12-years prior to initiating the proposed intervention, community coalitions and intervention teams were organised and funded in the intervention communities.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Within the total sample size of 500, mean reductions of at least 0.25 standard deviations [SD] will be detectable (at power 0.8) at the 3-month measurement point in Grade 8 family conflict in the intervention compared to the control group. Statistical tests will also be able to detect reductions of at least 0.25 SDs comparing the intervention relative to the controls in secondary outcomes of: [1] social emotional skills; [2] school engagement; [3] alcohol and tobacco use; and [4] online behaviour problems / low cyber safety .

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/07/2018
Actual
Date of last participant enrolment
Anticipated
1/10/2018
Actual
Date of last data collection
Anticipated
13/12/2018
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 22625 0
3220 - Geelong
Recruitment postcode(s) [2] 22626 0
3152 - Knox City Centre
Recruitment postcode(s) [3] 22627 0
3820 - Warragul
Recruitment postcode(s) [4] 22628 0
3064 - Craigieburn
Recruitment postcode(s) [5] 22629 0
3630 - Shepparton
Recruitment postcode(s) [6] 22630 0
3844 - Traralgon
Recruitment postcode(s) [7] 22631 0
3016 - Williamstown
Recruitment postcode(s) [8] 22633 0
3825 - Moe
Recruitment postcode(s) [9] 22634 0
3981 - Koo Wee Rup

Funding & Sponsors
Funding source category [1] 299441 0
University
Name [1] 299441 0
Deakin University
Country [1] 299441 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
75 Pigdons Road Waurn Ponds VIC 3216. Australia
Country
Australia
Secondary sponsor category [1] 298731 0
None
Name [1] 298731 0
Address [1] 298731 0
Country [1] 298731 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300339 0
Deakin University
Ethics committee address [1] 300339 0
Ethics committee country [1] 300339 0
Australia
Date submitted for ethics approval [1] 300339 0
17/07/2017
Approval date [1] 300339 0
29/08/2017
Ethics approval number [1] 300339 0
2017-215

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

Contacts
Principal investigator
Name 83350 0
Prof John Toumbourou
Address 83350 0
Deakin University
Waterfront Campus
Geelong 3220 Victoria
Country 83350 0
Australia
Phone 83350 0
+61352278278
Fax 83350 0
+61352278621
Email 83350 0
[email protected]
Contact person for public queries
Name 83351 0
John Toumbourou
Address 83351 0
Deakin University
Waterfront Campus
Geelong 3220 Victoria
Country 83351 0
Australia
Phone 83351 0
+61352278278
Fax 83351 0
+61352278621
Email 83351 0
[email protected]
Contact person for scientific queries
Name 83352 0
John Toumbourou
Address 83352 0
Deakin University
Waterfront Campus
Geelong 3220 Victoria
Country 83352 0
Australia
Phone 83352 0
+61352278278
Fax 83352 0
+61352278621
Email 83352 0
[email protected]

No information has been provided regarding IPD availability


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
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