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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]

Nil

Universal Trial Number (UTN)

U1111-1169-0410

Trial acronym

Linked study record

Health condition

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

Anxiety disorders

Internalising disorders

Condition category

Condition code

Mental Health

Anxiety

Mental Health

Depression

Public Health

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]

Treatment: Other

Intervention code [2]

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]

Anxiety levels on the Preschool Anxiety Scale and Spence Children’s Anxiety Scale

Timepoint [1]

Following completion of treatment (20 weeks for both groups) and at 6 month follow-up

Primary outcome [2]

Resilience using the Deveruex Student Strengths Assessment and Devereux Early Childhood Assessment

Timepoint [2]

Following completion of treatment (20 weeks for both groups) and at 6 month follow-up

Secondary outcome [1]

Behaviour problems on the Strengths and Difficulties Questionnaire

Timepoint [1]

Following completion of treatment (20 weeks for both groups) and at 6 month follow-up

Secondary outcome [2]

Bullying prevalence on the Olweus Bully/Victim Questionnaire

Timepoint [2]

Following completion of treatment (20 weeks for the standard group) and at 6-month follow-up

Secondary outcome [3]

School climate levels on the School Climate Survey

Timepoint [3]

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]

Charities/Societies/Foundations

Name [1]

FRIENDS Programs International Foundation

Address [1]

7/88 Boundary St, West End QLD 4101

Country [1]

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]

University

Name [1]

Australian National University

Address [1]

Australian National University, Acton ACT 2601

Country [1]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Australian National University Human Research Ethics Committee

Ethics committee address [1]

Australian National University, Acton ACT 2601

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/04/2015

Approval date [1]

Ethics approval number [1]

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

Ms Marita Cooper

Address

Ms Marita Cooper, FRIENDS Programs International, 7/88 Boundary St, West End 4101 QLD

Country

Australia

Phone

+61410716983

Fax

[email protected]

Contact person for public queries

Name

Marita Cooper

Address

Ms Marita Cooper, FRIENDS Programs International, 7/88 Boundary St, West End 4101 QLD

Country

Australia

Phone

+61 410 716983

Fax

[email protected]

Contact person for scientific queries

Name

Marita Cooper

Address

Ms Marita Cooper, FRIENDS Programs International, 7/88 Boundary St, West End 4101 QLD

Country

Australia

Phone

+61410716983

Fax

[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.

Trial Review

Documents added manually

Documents added automatically