Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
ACTRN12615000265572
Ethics application status
Not yet submitted
Date submitted
19/01/2015
Date registered
20/03/2015
Date last updated
20/03/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The FRIENDS anxiety treatment program: Do treatment length and additional parent resilience interventions affect child outcomes
Scientific title
Comparing FRIENDS anxiety treatment as is with intensive delivery and additional parenting component: Effects on
child anxiety and resilience in a community clinic setting
Secondary ID [1] 285990 0
Nil
Universal Trial Number (UTN)
U1111-1166-0862
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety disorders 293941 0
Condition category
Condition code
Mental Health 294239 294239 0 0
Anxiety

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 intensive format will be the same content as the standard session content simply presented more frequently over 2 weeks (as opposed to 10 weeks), whereby each session will be completed daily Mon-Fri rather than weekly. The parent resilience format will provide the Adult Resilience 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. 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 10 weeks for the standard format and daily (Mon-Fri) over 2 weeks for the intensive group. Both formats will be a 90-minute session conducted either by a registered psychologist or clinical psychologist. 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.

Overall there will be three modes/arms of intervention:
Arm 1: FRIENDS program only (see active comparison below)
Arm 2: Standard FRIENDS program and conjunctive adult resilience component (over 10 weeks)
Arm 3: Intensive FRIENDS program and conjunctive adult resilience component (over 2 weeks)
Intervention code [1] 290966 0
Treatment: Other
Intervention code [2] 291149 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 10x90minute sessions conducted on a weekly basis. This will not include the parent resilience component.
Control group
Active

Outcomes
Primary outcome [1] 294042 0
Anxiety levels on the Preschool Anxiety Scale and Spence Children’s Anxiety Scale
Timepoint [1] 294042 0
Following completion of treatment (2 weeks for the intensive group and 10 weeks for the standard group) and at 12 month follow-up
Secondary outcome [1] 312399 0
Resilience using the Deveruex Student Strengths Assessment and Devereux Early Childhood Assessment
Timepoint [1] 312399 0
Following completion of treatment (2 weeks for the intensive group and 10 weeks for the standard group) and at 12 month follow-up
Secondary outcome [2] 312400 0
Behaviour problems on the Strengths and Difficulties Questionnaire
Timepoint [2] 312400 0
Following completion of treatment (2 weeks for the intensive group and 10 weeks for the standard group) and at 12 month follow-up

Eligibility
Key inclusion criteria
All clients attending the community clinic for group treatment will be invited to complete the research. There will be no inclusion criteria regarding levels of symptomology or a determined diagnosis. Clients may attend the clinic following GP referral, school referral or self-referral. The study intends to represent a real-world clinic to increase clinical applicability rather than a restricted university-clinic sample.
Minimum age
4 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants must complete at least 50% of the intervention. Participants who are unlikely to benefit from group treatment or those likely to disrupt the treatment of others will be excluded (and offered individual psychological services). Furthermore, those at risk of harming themselves or others will be offered individual services.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
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 (0.45), 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, 12-month followup) on child outcome variables. Furthermore, for the active condition, 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
30/03/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 290581 0
Charities/Societies/Foundations
Name [1] 290581 0
Friends Programs International
Country [1] 290581 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] 289269 0
University
Name [1] 289269 0
Australian National University
Address [1] 289269 0
Australian National University, Acton Canberra ACT 2601
Country [1] 289269 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 292220 0
Australian National University Human Research Ethics Committee
Ethics committee address [1] 292220 0
Ethics committee country [1] 292220 0
Australia
Date submitted for ethics approval [1] 292220 0
11/02/2015
Approval date [1] 292220 0
Ethics approval number [1] 292220 0

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

Contacts
Principal investigator
Name 54158 0
Ms Marita Cooper
Address 54158 0
Ms Marita Cooper, FRIENDS Programs International, 7/88 Boundary St, West End 4101 QLD
Country 54158 0
Australia
Phone 54158 0
+61 410 716983
Fax 54158 0
Email 54158 0
[email protected]
Contact person for public queries
Name 54159 0
Marita Cooper
Address 54159 0
Ms Marita Cooper, FRIENDS Programs International, 7/88 Boundary St, West End 4101 QLD
Country 54159 0
Australia
Phone 54159 0
+61 410 716983
Fax 54159 0
Email 54159 0
[email protected]
Contact person for scientific queries
Name 54160 0
Marita Cooper
Address 54160 0
Ms Marita Cooper, FRIENDS Programs International, 7/88 Boundary St, West End 4101 QLD
Country 54160 0
Australia
Phone 54160 0
+61410716983
Fax 54160 0
Email 54160 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.