Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000382572
Ethics application status
Not yet submitted
Date submitted
7/04/2015
Date registered
27/04/2015
Date last updated
27/04/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The FRIENDS anxiety prevention program: Does an additional parent resilience intervention affect child outcomes
Scientific title
Comparing standard FRIENDS anxiety prevention with the prevention plus an additional parenting component: Effects on
child anxiety and resilience in an educational setting
Secondary ID [1] 286483 0
Nil
Universal Trial Number (UTN)
U1111-1169-0410
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety disorders 294677 0
Internalising disorders 294678 0
Condition category
Condition code
Mental Health 294980 294980 0 0
Anxiety
Mental Health 294981 294981 0 0
Depression
Public Health 295050 295050 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The FRIENDS programs (Fun FRIENDS, FRIENDS for Life, My Youth FRIENDS, Adult Resilience; Barrett, 2012) will be utilised. The parent resilience format will provide the Adult Resilience (a one-day *8 hour program) to parents of children completing the FF, FFL or MYF programs. Allocation to the groups of Fun FRIENDS, FRIENDS for Life or My Youth FRIENDS is determined by age, groups are 4-7 y/o, 8-11 y/o and 12-15 y/o respectively. Classrooms will be randomized to determine the timing of parental intervention (either during the child intervention or 6-months following intervention). The FRIENDS programs are robustly supported anxiety treatment programs with over 50 published articles supporting their use in children and adolescents. Strategies are based on a cognitive behavioural framework and delivered in a group clinical setting. The frequency of sessions is weekly over 20 weeks for the standard format. These will be a 50-minute session conducted by a classroom teacher accredited in the programs (having received a minimum of one-day training). The FRIENDS programs (including all 3 children and the adult program) incorporate physiological, cognitive, and behavioral strategies to assist children and adolescents in coping with stress and worry. The behavioral component includes exposure, relaxation training, assertiveness training, coping and problem solving plans, and conflict resolution. The cognitive component teaches children and adolescents to recognize their feelings and thoughts and the link between them. It also teaches them to identify faulty cognitions and incompatible self-statements, and to elaborate alternative interpretations of difficult situations. Through the program, protective factors such as self-esteem, self-concept, coping skills, hope, and social support are enhanced. The treatment integrity of the child component of the program (FF, FFL, MYF) will be monitored via self-report forms using a Treatment Integrity checklist. The treatment integrity of the adult component of the program (AR) will be monitored by independent reviewers checking the treatment integrity checklist in vivo.

Overall there will be two modes/arms of intervention:
Arm 1: FRIENDS program only (see active comparison below; these will receive the conjunctive adult component at 6-month followup)
Arm 2: Standard FRIENDS program and conjunctive adult resilience component (over 20 weeks)
Intervention code [1] 291574 0
Treatment: Other
Intervention code [2] 291575 0
Behaviour
Comparator / control treatment
An active control is being utilised which is the FRIENDS programs in their standard format. As noted above, the standard format will be 20x50minute sessions conducted on a weekly basis. This will only include the parent resilience component at 6-month followup.
Control group
Active

Outcomes
Primary outcome [1] 294731 0
Anxiety levels on the Preschool Anxiety Scale and Spence Children’s Anxiety Scale
Timepoint [1] 294731 0
Following completion of treatment (20 weeks for both groups) and at 6 month follow-up
Primary outcome [2] 294732 0
Resilience using the Deveruex Student Strengths Assessment and Devereux Early Childhood Assessment
Timepoint [2] 294732 0
Following completion of treatment (20 weeks for both groups) and at 6 month follow-up
Secondary outcome [1] 313954 0
Behaviour problems on the Strengths and Difficulties Questionnaire
Timepoint [1] 313954 0
Following completion of treatment (20 weeks for both groups) and at 6 month follow-up
Secondary outcome [2] 313957 0
Bullying prevalence on the Olweus Bully/Victim Questionnaire
Timepoint [2] 313957 0
Following completion of treatment (20 weeks for the standard group) and at 6-month follow-up
Secondary outcome [3] 313958 0
School climate levels on the School Climate Survey
Timepoint [3] 313958 0
Following completion of treatment (20 weeks for the standard group) and at 6 month follow-up

Eligibility
Key inclusion criteria
All children and their families in the grade years undertaking the FRIENDS program at the school will be invited to complete the research. There will be no inclusion criteria regarding levels of symptomology or a determined diagnosis.
Minimum age
4 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

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 will be concealed. The allocation will be randomised through the use of a computer generated randomiser. Each participant will be allocated a random number and then sorted into the standard or enhanced intervention group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be sorted into groups utilising permuted block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A priori power analysis will be conducted using G*Power to find appropriate sample size utilising effect sizes from previous studies (0.2), significance level (.05) a desired power level of .80. Data will be compiled and analysed using SPSS version 20.0. A split-plot analysis of variance will be used to explore the effects of the adult intervention and phase (pre, post, 6-month followup) on child outcome variables. Furthermore, moderation analyses will be used to evaluate whether the extent of parental resilience outcomes has an effect on child outcomes. Correlations will explore relationships between all of the variables including the demographic variables.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 291050 0
Charities/Societies/Foundations
Name [1] 291050 0
FRIENDS Programs International Foundation
Country [1] 291050 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Friends Programs International
Address
7/88 Boundary St, West End QLD 4101
Country
Australia
Secondary sponsor category [1] 289733 0
University
Name [1] 289733 0
Australian National University
Address [1] 289733 0
Australian National University, Acton ACT 2601
Country [1] 289733 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 292633 0
Australian National University Human Research Ethics Committee
Ethics committee address [1] 292633 0
Australian National University, Acton ACT 2601
Ethics committee country [1] 292633 0
Australia
Date submitted for ethics approval [1] 292633 0
14/04/2015
Approval date [1] 292633 0
Ethics approval number [1] 292633 0

Summary
Brief summary
The etiology of mental ill-health is commonly complex and can often involve not one but a chain of genetic, environmental, social and psychological risk factors. Understanding these risk factors is essential to being able to identify children at risk of developing future mental health difficulties, planning appropriate timing of an intervention and ascertaining necessary treatment components for any intervention. Risk factors may be individual, familial and environmental characteristics that increase the likelihood of adverse developmental outcomes. Although no single risk factor is either necessary or sufficient in the development of a specific disorder, the commonly indicated risk factors in young children are parental psychopathology, temperament and prior symptomology.

Parental psychopathology is commonly accepted as a risk factor for both genetic and environmental pathways towards childhood mental health problems. Family aggregation studies of both the offspring of clinically diagnosed parents and parents of children with mental health difficulties have demonstrated the heritability of mental disorders Connell and Goodman’s meta-analytic review investigated the associations between parental psychopathology and internalizing and externalizing disorders in their children. Based on the 230 articles identified on parental mental health concerns and childhood internalizing difficulties, the authors found that both maternal and paternal psychopathology significantly predicted childhood symptomology. It should be noted, however, that weighted mean effect sizes in this study were small. Additionally, it was found that effects were moderated by child factors, including age and gender, as well as type of parental diagnosis. These findings suggest that the relationship between parental psychopathology and child psychopathology is not a simple direct linear association. Rather, the interaction of parental influences and child influences is more likely to determine future symptomology.

Despite an exponential increase in resilience research for children, there is currently a lack of evidence exploring how adult resilience affects the development of childhood resilience. As the link between vulnerability factors, protective factors and wellbeing in psychopathological pathways is unclear, it cannot be assumed that the heritability and modeling of psychopathology between parent and child directly indicates a similar link relationship for parent and child resilience. As such, this study will to explore both the relationship between parent-child resilience and symptomology and how resilience enhancement in parents affects children’s resilience and symptomology intervention outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56330 0
Ms Marita Cooper
Address 56330 0
Ms Marita Cooper, FRIENDS Programs International, 7/88 Boundary St, West End 4101 QLD
Country 56330 0
Australia
Phone 56330 0
+61410716983
Fax 56330 0
Email 56330 0
[email protected]
Contact person for public queries
Name 56331 0
Marita Cooper
Address 56331 0
Ms Marita Cooper, FRIENDS Programs International, 7/88 Boundary St, West End 4101 QLD
Country 56331 0
Australia
Phone 56331 0
+61 410 716983
Fax 56331 0
Email 56331 0
[email protected]
Contact person for scientific queries
Name 56332 0
Marita Cooper
Address 56332 0
Ms Marita Cooper, FRIENDS Programs International, 7/88 Boundary St, West End 4101 QLD
Country 56332 0
Australia
Phone 56332 0
+61410716983
Fax 56332 0
Email 56332 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
No additional documents have been identified.